Mitchel L. Zoler, PhD

PHILADELPHIA – A weeklong course of empiric antibiotic treatment in neonates may result in a higher subsequent rate of chronic lung disease, compared with infants treated for just 2 days, based on an association seen in a review of more than 900 very low birth weight newborns.

But this finding is not yet ready to definitively guide practice, as it came from a nonrandomized, retrospective study that may have failed to control for all possible confounding variables, Dr. Alexandra Novitsky said at the annual meeting of the Eastern Society for Pediatric Research.

In her adjusted analysis, which controlled for several baseline variables, the 159 very low birth weight (VLBW) neonates who received a "long" course of empiric antibiotic treatment, usually for 7 days, had a statistically significant, twofold higher rate of also having chronic lung disease during follow-up, compared with the 747 neonates who received a "short" antibiotic course, usually for 2 days, said Dr. Novitsky, a neonatologist at Christiana Hospital in Newark, Del.

"It’s too early to draw conclusions about changing therapy," based on this finding, said Dr. David A. Paul, associate director of neonatology at Christiana Hospital, who collaborated on the analysis. "We did our best to control for possible confounders, and it still suggested that longer antibiotic treatment altered outcomes, but there may have been things [for which] we did not control," he said in an interview. The next step is to design a prospective study and determine if changing the duration of empiric antibiotic therapy changes outcomes. "But the current findings raise concern that we should be cautious about the duration of treatment," said Dr. Paul.

In the cases reviewed, each physician delivering care determined the duration of antibiotic treatment. Some may have opted for a longer course of treatment because they were concerned that "not all babies have culture-proven sepsis," Dr. Paul said in an interview. The physicians "may have feared that the babies had infections that were missed in their blood cultures. They treated presumed sepsis," he said.

Dr. Novitsky reviewed all the VLBW infants seen in the neonatal ICU at Christiana Hospital between July 2004 and June 2009. The regimen used on all neonates who received empiric antibiotic treatment consisted of ampicillin and gentamicin. The infants who received a longer antibiotic course had a significantly higher prevalence of several markers of a worse clinical profile, including lower birth weight, younger gestational age, a higher score for neonatal acute physiology (SNAP), and a lower 5-minute Apgar score. They also had higher rates of clinical chorioamnionitis, mechanical ventilation, and endotracheal tube colonization (endotracheal tubes underwent routine, weekly colonization assessments).

The infants who received a longer course of antibiotics also had a higher prevalence of antibiotic-resistant, gram-negative organisms colonizing their endotracheal tubes, a 6% rate, compared with a 2% rate among the infants who received a short course of treatment – a significant difference. The two groups of infants had roughly identical prevalence rates of colonization with antibiotic-resistant gram-positive strains.

Dr. Novitsky defined the primary outcome evaluated in the analysis, chronic lung disease, as the need for supplemental oxygen by the infant at 36 weeks postmenstrual age. This outcome occurred in 185 of the 906 (20%) neonates in the study: 17% of the infants who received a short antibiotic course, and 36% of those who received a long course.

The multivariable analysis adjusted for differences in gestational age, SNAP score, Apgar score, maternal antibiotic treatment, chorioamnionitis, pre-eclampsia, cesarean delivery, prolonged rupture of membranes, and need for mechanical ventilation. After adjustment, the two patient groups failed to show a significant difference in their rates of necrotizing enterocolitis or sepsis.

To further examine the relationship between duration of antibiotic treatment and chronic lung disease, Dr. Novitsky also presented the results of a subgroup analysis that focused on the 418 high-risk neonates in her study group, because of their delivery at 28 weeks’ gestation or younger and their SNAP score of 8 or greater. Within this subgroup, the adjusted rate for developing chronic lung disease ran 70% higher in the 108 infants who received a long course of antibiotics, compared with the 310 who received a short course, also a significant difference.

Dr. Novitsky and Dr. Paul said they had no relevant financial disclosures.

PHILADELPHIA – A weeklong course of empiric antibiotic treatment in neonates may result in a higher subsequent rate of chronic lung disease, compared with infants treated for just 2 days, based on an association seen in a review of more than 900 very low birth weight newborns.

But this finding is not yet ready to definitively guide practice, as it came from a nonrandomized, retrospective study that may have failed to control for all possible confounding variables, Dr. Alexandra Novitsky said at the annual meeting of the Eastern Society for Pediatric Research.

In her adjusted analysis, which controlled for several baseline variables, the 159 very low birth weight (VLBW) neonates who received a "long" course of empiric antibiotic treatment, usually for 7 days, had a statistically significant, twofold higher rate of also having chronic lung disease during follow-up, compared with the 747 neonates who received a "short" antibiotic course, usually for 2 days, said Dr. Novitsky, a neonatologist at Christiana Hospital in Newark, Del.

"It’s too early to draw conclusions about changing therapy," based on this finding, said Dr. David A. Paul, associate director of neonatology at Christiana Hospital, who collaborated on the analysis. "We did our best to control for possible confounders, and it still suggested that longer antibiotic treatment altered outcomes, but there may have been things [for which] we did not control," he said in an interview. The next step is to design a prospective study and determine if changing the duration of empiric antibiotic therapy changes outcomes. "But the current findings raise concern that we should be cautious about the duration of treatment," said Dr. Paul.

In the cases reviewed, each physician delivering care determined the duration of antibiotic treatment. Some may have opted for a longer course of treatment because they were concerned that "not all babies have culture-proven sepsis," Dr. Paul said in an interview. The physicians "may have feared that the babies had infections that were missed in their blood cultures. They treated presumed sepsis," he said.

Dr. Novitsky reviewed all the VLBW infants seen in the neonatal ICU at Christiana Hospital between July 2004 and June 2009. The regimen used on all neonates who received empiric antibiotic treatment consisted of ampicillin and gentamicin. The infants who received a longer antibiotic course had a significantly higher prevalence of several markers of a worse clinical profile, including lower birth weight, younger gestational age, a higher score for neonatal acute physiology (SNAP), and a lower 5-minute Apgar score. They also had higher rates of clinical chorioamnionitis, mechanical ventilation, and endotracheal tube colonization (endotracheal tubes underwent routine, weekly colonization assessments).

The infants who received a longer course of antibiotics also had a higher prevalence of antibiotic-resistant, gram-negative organisms colonizing their endotracheal tubes, a 6% rate, compared with a 2% rate among the infants who received a short course of treatment – a significant difference. The two groups of infants had roughly identical prevalence rates of colonization with antibiotic-resistant gram-positive strains.

Dr. Novitsky defined the primary outcome evaluated in the analysis, chronic lung disease, as the need for supplemental oxygen by the infant at 36 weeks postmenstrual age. This outcome occurred in 185 of the 906 (20%) neonates in the study: 17% of the infants who received a short antibiotic course, and 36% of those who received a long course.

The multivariable analysis adjusted for differences in gestational age, SNAP score, Apgar score, maternal antibiotic treatment, chorioamnionitis, pre-eclampsia, cesarean delivery, prolonged rupture of membranes, and need for mechanical ventilation. After adjustment, the two patient groups failed to show a significant difference in their rates of necrotizing enterocolitis or sepsis.

To further examine the relationship between duration of antibiotic treatment and chronic lung disease, Dr. Novitsky also presented the results of a subgroup analysis that focused on the 418 high-risk neonates in her study group, because of their delivery at 28 weeks’ gestation or younger and their SNAP score of 8 or greater. Within this subgroup, the adjusted rate for developing chronic lung disease ran 70% higher in the 108 infants who received a long course of antibiotics, compared with the 310 who received a short course, also a significant difference.

Dr. Novitsky and Dr. Paul said they had no relevant financial disclosures.

PHILADELPHIA – A weeklong course of empiric antibiotic treatment in neonates may result in a higher subsequent rate of chronic lung disease, compared with infants treated for just 2 days, based on an association seen in a review of more than 900 very low birth weight newborns.

But this finding is not yet ready to definitively guide practice, as it came from a nonrandomized, retrospective study that may have failed to control for all possible confounding variables, Dr. Alexandra Novitsky said at the annual meeting of the Eastern Society for Pediatric Research.

In her adjusted analysis, which controlled for several baseline variables, the 159 very low birth weight (VLBW) neonates who received a "long" course of empiric antibiotic treatment, usually for 7 days, had a statistically significant, twofold higher rate of also having chronic lung disease during follow-up, compared with the 747 neonates who received a "short" antibiotic course, usually for 2 days, said Dr. Novitsky, a neonatologist at Christiana Hospital in Newark, Del.

"It’s too early to draw conclusions about changing therapy," based on this finding, said Dr. David A. Paul, associate director of neonatology at Christiana Hospital, who collaborated on the analysis. "We did our best to control for possible confounders, and it still suggested that longer antibiotic treatment altered outcomes, but there may have been things [for which] we did not control," he said in an interview. The next step is to design a prospective study and determine if changing the duration of empiric antibiotic therapy changes outcomes. "But the current findings raise concern that we should be cautious about the duration of treatment," said Dr. Paul.

In the cases reviewed, each physician delivering care determined the duration of antibiotic treatment. Some may have opted for a longer course of treatment because they were concerned that "not all babies have culture-proven sepsis," Dr. Paul said in an interview. The physicians "may have feared that the babies had infections that were missed in their blood cultures. They treated presumed sepsis," he said.

Dr. Novitsky reviewed all the VLBW infants seen in the neonatal ICU at Christiana Hospital between July 2004 and June 2009. The regimen used on all neonates who received empiric antibiotic treatment consisted of ampicillin and gentamicin. The infants who received a longer antibiotic course had a significantly higher prevalence of several markers of a worse clinical profile, including lower birth weight, younger gestational age, a higher score for neonatal acute physiology (SNAP), and a lower 5-minute Apgar score. They also had higher rates of clinical chorioamnionitis, mechanical ventilation, and endotracheal tube colonization (endotracheal tubes underwent routine, weekly colonization assessments).

The infants who received a longer course of antibiotics also had a higher prevalence of antibiotic-resistant, gram-negative organisms colonizing their endotracheal tubes, a 6% rate, compared with a 2% rate among the infants who received a short course of treatment – a significant difference. The two groups of infants had roughly identical prevalence rates of colonization with antibiotic-resistant gram-positive strains.

Dr. Novitsky defined the primary outcome evaluated in the analysis, chronic lung disease, as the need for supplemental oxygen by the infant at 36 weeks postmenstrual age. This outcome occurred in 185 of the 906 (20%) neonates in the study: 17% of the infants who received a short antibiotic course, and 36% of those who received a long course.

The multivariable analysis adjusted for differences in gestational age, SNAP score, Apgar score, maternal antibiotic treatment, chorioamnionitis, pre-eclampsia, cesarean delivery, prolonged rupture of membranes, and need for mechanical ventilation. After adjustment, the two patient groups failed to show a significant difference in their rates of necrotizing enterocolitis or sepsis.

To further examine the relationship between duration of antibiotic treatment and chronic lung disease, Dr. Novitsky also presented the results of a subgroup analysis that focused on the 418 high-risk neonates in her study group, because of their delivery at 28 weeks’ gestation or younger and their SNAP score of 8 or greater. Within this subgroup, the adjusted rate for developing chronic lung disease ran 70% higher in the 108 infants who received a long course of antibiotics, compared with the 310 who received a short course, also a significant difference.

Dr. Novitsky and Dr. Paul said they had no relevant financial disclosures.

PHILADELPHIA – A weeklong course of empiric antibiotic treatment in neonates may result in a higher subsequent rate of chronic lung disease, compared with infants treated for just 2 days, based on an association seen in a review of more than 900 very low birth weight newborns.

But this finding is not yet ready to definitively guide practice, as it came from a nonrandomized, retrospective study that may have failed to control for all possible confounding variables, Dr. Alexandra Novitsky said at the annual meeting of the Eastern Society for Pediatric Research.

In her adjusted analysis, which controlled for several baseline variables, the 159 very low birth weight (VLBW) neonates who received a "long" course of empiric antibiotic treatment, usually for 7 days, had a statistically significant, twofold higher rate of also having chronic lung disease during follow-up, compared with the 747 neonates who received a "short" antibiotic course, usually for 2 days, said Dr. Novitsky, a neonatologist at Christiana Hospital in Newark, Del.

"It’s too early to draw conclusions about changing therapy," based on this finding, said Dr. David A. Paul, associate director of neonatology at Christiana Hospital, who collaborated on the analysis. "We did our best to control for possible confounders, and it still suggested that longer antibiotic treatment altered outcomes, but there may have been things [for which] we did not control," he said in an interview. The next step is to design a prospective study and determine if changing the duration of empiric antibiotic therapy changes outcomes. "But the current findings raise concern that we should be cautious about the duration of treatment," said Dr. Paul.

In the cases reviewed, each physician delivering care determined the duration of antibiotic treatment. Some may have opted for a longer course of treatment because they were concerned that "not all babies have culture-proven sepsis," Dr. Paul said in an interview. The physicians "may have feared that the babies had infections that were missed in their blood cultures. They treated presumed sepsis," he said.

Dr. Novitsky reviewed all the VLBW infants seen in the neonatal ICU at Christiana Hospital between July 2004 and June 2009. The regimen used on all neonates who received empiric antibiotic treatment consisted of ampicillin and gentamicin. The infants who received a longer antibiotic course had a significantly higher prevalence of several markers of a worse clinical profile, including lower birth weight, younger gestational age, a higher score for neonatal acute physiology (SNAP), and a lower 5-minute Apgar score. They also had higher rates of clinical chorioamnionitis, mechanical ventilation, and endotracheal tube colonization (endotracheal tubes underwent routine, weekly colonization assessments).

The infants who received a longer course of antibiotics also had a higher prevalence of antibiotic-resistant, gram-negative organisms colonizing their endotracheal tubes, a 6% rate, compared with a 2% rate among the infants who received a short course of treatment – a significant difference. The two groups of infants had roughly identical prevalence rates of colonization with antibiotic-resistant gram-positive strains.

Dr. Novitsky defined the primary outcome evaluated in the analysis, chronic lung disease, as the need for supplemental oxygen by the infant at 36 weeks postmenstrual age. This outcome occurred in 185 of the 906 (20%) neonates in the study: 17% of the infants who received a short antibiotic course, and 36% of those who received a long course.

The multivariable analysis adjusted for differences in gestational age, SNAP score, Apgar score, maternal antibiotic treatment, chorioamnionitis, pre-eclampsia, cesarean delivery, prolonged rupture of membranes, and need for mechanical ventilation. After adjustment, the two patient groups failed to show a significant difference in their rates of necrotizing enterocolitis or sepsis.

To further examine the relationship between duration of antibiotic treatment and chronic lung disease, Dr. Novitsky also presented the results of a subgroup analysis that focused on the 418 high-risk neonates in her study group, because of their delivery at 28 weeks’ gestation or younger and their SNAP score of 8 or greater. Within this subgroup, the adjusted rate for developing chronic lung disease ran 70% higher in the 108 infants who received a long course of antibiotics, compared with the 310 who received a short course, also a significant difference.

Dr. Novitsky and Dr. Paul said they had no relevant financial disclosures.

PHILADELPHIA – A weeklong course of empiric antibiotic treatment in neonates may result in a higher subsequent rate of chronic lung disease, compared with infants treated for just 2 days, based on an association seen in a review of more than 900 very low birth weight newborns.

But this finding is not yet ready to definitively guide practice, as it came from a nonrandomized, retrospective study that may have failed to control for all possible confounding variables, Dr. Alexandra Novitsky said at the annual meeting of the Eastern Society for Pediatric Research.

In her adjusted analysis, which controlled for several baseline variables, the 159 very low birth weight (VLBW) neonates who received a "long" course of empiric antibiotic treatment, usually for 7 days, had a statistically significant, twofold higher rate of also having chronic lung disease during follow-up, compared with the 747 neonates who received a "short" antibiotic course, usually for 2 days, said Dr. Novitsky, a neonatologist at Christiana Hospital in Newark, Del.

"It’s too early to draw conclusions about changing therapy," based on this finding, said Dr. David A. Paul, associate director of neonatology at Christiana Hospital, who collaborated on the analysis. "We did our best to control for possible confounders, and it still suggested that longer antibiotic treatment altered outcomes, but there may have been things [for which] we did not control," he said in an interview. The next step is to design a prospective study and determine if changing the duration of empiric antibiotic therapy changes outcomes. "But the current findings raise concern that we should be cautious about the duration of treatment," said Dr. Paul.

In the cases reviewed, each physician delivering care determined the duration of antibiotic treatment. Some may have opted for a longer course of treatment because they were concerned that "not all babies have culture-proven sepsis," Dr. Paul said in an interview. The physicians "may have feared that the babies had infections that were missed in their blood cultures. They treated presumed sepsis," he said.

Dr. Novitsky reviewed all the VLBW infants seen in the neonatal ICU at Christiana Hospital between July 2004 and June 2009. The regimen used on all neonates who received empiric antibiotic treatment consisted of ampicillin and gentamicin. The infants who received a longer antibiotic course had a significantly higher prevalence of several markers of a worse clinical profile, including lower birth weight, younger gestational age, a higher score for neonatal acute physiology (SNAP), and a lower 5-minute Apgar score. They also had higher rates of clinical chorioamnionitis, mechanical ventilation, and endotracheal tube colonization (endotracheal tubes underwent routine, weekly colonization assessments).

The infants who received a longer course of antibiotics also had a higher prevalence of antibiotic-resistant, gram-negative organisms colonizing their endotracheal tubes, a 6% rate, compared with a 2% rate among the infants who received a short course of treatment – a significant difference. The two groups of infants had roughly identical prevalence rates of colonization with antibiotic-resistant gram-positive strains.

Dr. Novitsky defined the primary outcome evaluated in the analysis, chronic lung disease, as the need for supplemental oxygen by the infant at 36 weeks postmenstrual age. This outcome occurred in 185 of the 906 (20%) neonates in the study: 17% of the infants who received a short antibiotic course, and 36% of those who received a long course.

The multivariable analysis adjusted for differences in gestational age, SNAP score, Apgar score, maternal antibiotic treatment, chorioamnionitis, pre-eclampsia, cesarean delivery, prolonged rupture of membranes, and need for mechanical ventilation. After adjustment, the two patient groups failed to show a significant difference in their rates of necrotizing enterocolitis or sepsis.

To further examine the relationship between duration of antibiotic treatment and chronic lung disease, Dr. Novitsky also presented the results of a subgroup analysis that focused on the 418 high-risk neonates in her study group, because of their delivery at 28 weeks’ gestation or younger and their SNAP score of 8 or greater. Within this subgroup, the adjusted rate for developing chronic lung disease ran 70% higher in the 108 infants who received a long course of antibiotics, compared with the 310 who received a short course, also a significant difference.

Dr. Novitsky and Dr. Paul said they had no relevant financial disclosures.

PHILADELPHIA – A weeklong course of empiric antibiotic treatment in neonates may result in a higher subsequent rate of chronic lung disease, compared with infants treated for just 2 days, based on an association seen in a review of more than 900 very low birth weight newborns.

But this finding is not yet ready to definitively guide practice, as it came from a nonrandomized, retrospective study that may have failed to control for all possible confounding variables, Dr. Alexandra Novitsky said at the annual meeting of the Eastern Society for Pediatric Research.

In her adjusted analysis, which controlled for several baseline variables, the 159 very low birth weight (VLBW) neonates who received a "long" course of empiric antibiotic treatment, usually for 7 days, had a statistically significant, twofold higher rate of also having chronic lung disease during follow-up, compared with the 747 neonates who received a "short" antibiotic course, usually for 2 days, said Dr. Novitsky, a neonatologist at Christiana Hospital in Newark, Del.

"It’s too early to draw conclusions about changing therapy," based on this finding, said Dr. David A. Paul, associate director of neonatology at Christiana Hospital, who collaborated on the analysis. "We did our best to control for possible confounders, and it still suggested that longer antibiotic treatment altered outcomes, but there may have been things [for which] we did not control," he said in an interview. The next step is to design a prospective study and determine if changing the duration of empiric antibiotic therapy changes outcomes. "But the current findings raise concern that we should be cautious about the duration of treatment," said Dr. Paul.

In the cases reviewed, each physician delivering care determined the duration of antibiotic treatment. Some may have opted for a longer course of treatment because they were concerned that "not all babies have culture-proven sepsis," Dr. Paul said in an interview. The physicians "may have feared that the babies had infections that were missed in their blood cultures. They treated presumed sepsis," he said.

Dr. Novitsky reviewed all the VLBW infants seen in the neonatal ICU at Christiana Hospital between July 2004 and June 2009. The regimen used on all neonates who received empiric antibiotic treatment consisted of ampicillin and gentamicin. The infants who received a longer antibiotic course had a significantly higher prevalence of several markers of a worse clinical profile, including lower birth weight, younger gestational age, a higher score for neonatal acute physiology (SNAP), and a lower 5-minute Apgar score. They also had higher rates of clinical chorioamnionitis, mechanical ventilation, and endotracheal tube colonization (endotracheal tubes underwent routine, weekly colonization assessments).

The infants who received a longer course of antibiotics also had a higher prevalence of antibiotic-resistant, gram-negative organisms colonizing their endotracheal tubes, a 6% rate, compared with a 2% rate among the infants who received a short course of treatment – a significant difference. The two groups of infants had roughly identical prevalence rates of colonization with antibiotic-resistant gram-positive strains.

Dr. Novitsky defined the primary outcome evaluated in the analysis, chronic lung disease, as the need for supplemental oxygen by the infant at 36 weeks postmenstrual age. This outcome occurred in 185 of the 906 (20%) neonates in the study: 17% of the infants who received a short antibiotic course, and 36% of those who received a long course.

The multivariable analysis adjusted for differences in gestational age, SNAP score, Apgar score, maternal antibiotic treatment, chorioamnionitis, pre-eclampsia, cesarean delivery, prolonged rupture of membranes, and need for mechanical ventilation. After adjustment, the two patient groups failed to show a significant difference in their rates of necrotizing enterocolitis or sepsis.

To further examine the relationship between duration of antibiotic treatment and chronic lung disease, Dr. Novitsky also presented the results of a subgroup analysis that focused on the 418 high-risk neonates in her study group, because of their delivery at 28 weeks’ gestation or younger and their SNAP score of 8 or greater. Within this subgroup, the adjusted rate for developing chronic lung disease ran 70% higher in the 108 infants who received a long course of antibiotics, compared with the 310 who received a short course, also a significant difference.

Dr. Novitsky and Dr. Paul said they had no relevant financial disclosures.

NEW ORLEANS – Patients with severe psoriasis face a 6% higher 10-year risk for a cardiovascular event than do comparable people without psoriasis, according to the findings of a prospective cohort study of nearly 18,000 people.

This added cardiovascular risk can have substantial implications, as it can move psoriasis patients into a higher Framingham Risk Score category and shift the way physicians need to think about cardiovascular risk management of these patients, Dr. Nehal N. Mehta said at the annual meeting of the American College of Cardiology.

In his practice that focuses on adults with psoriasis, the average background Framingham Risk Score based on low density lipoprotein cholesterol is a 7% 10-year risk for having a cardiovascular event, a level defined as low risk. However, adding the 6% additional risk linked with their psoriasis results in many patients having a 10-year risk of 13% or higher, placing them in the intermediate risk category (generally defined as a 10%-20% risk of having a cardiovascular event).

Patients at that intermediate risk category usually have more stringent targets for lipid levels, blood pressure, and weight although, in this context, it's unclear whether patients who leap into a higher cardiovascular risk level because of their psoriasis require more aggressive medical management; cardiovascular risk management guidelines have yet to elucidate optimal management for this patient subgroup.

Dr. Mehta deals with this dilemma by implementing aggressive lifestyle interventions for these patients, and also by suggesting naturally occurring risk-reduction interventions, such as the consumption of fiber, red yeast rice, soy, phytoestrogens, fish oil, and niacin. If, after all these interventions, a patient's low density lipoprotein cholesterol or blood pressure remains at a questionably high level, he discusses the option of starting treatment with a statin or an antihypertensive medication, making clear that these steps have not yet been endorsed by most society management guidelines.

"Ultimately, about 5% of my psoriasis patients end up on a statin," said Dr. Mehta, a cardiologist and director of the inflammatory risk clinic in preventive cardiology at the University of Pennsylvania, Philadelphia.

Dr. Mehta and his associates derived an estimate of cardiovascular disease risk attributable to psoriasis by reviewing follow-up data maintained on 3,603 patients with severe psoriasis and 14,330 control participants without psoriasis enrolled in the General Practice Research Database, a collection of records from more than 5 million people seen by U.K. general practice physicians. The researchers identified cases of severe psoriasis based on their receiving systemic therapy or phototherapy and excluded people with a prior history of cardiovascular events. The average age of all the people in the analysis was about 50 years and, on average, people were followed for about 3 years.

In a multivariable analysis that controlled for diabetes, hypertension, hyperlipidemia, age, gender, body mass index, and smoking status, the risk for a myocardial infarction, stroke, or death from a cardiovascular cause was 53% higher among the psoriasis patients, compared with the controls, a statistically significant difference. This higher cardiovascular risk among patients with psoriasis matched the 50% increased risk proposed last year for patients with rheumatoid arthritis and other forms of inflammatory arthritis including psoriatic arthritis, according to a panel convened by the European League Against Rheumatism (Ann. Rheum. Dis. 2010;69:325-31).

To translate the 1.53 relative risk into an attributable risk, Dr. Mehta and his associates multiplied that factor against the background cardiovascular risk for someone in the general population of the study to derive an adjusted risk. They then subtracted the background risk from the adjusted risk. Over a 10-year period, this translated into an excess risk for a cardiovascular event of 6.2%.

To illustrate the potential impact of this estimate, the researchers then applied this to a consecutive sample of 103 psoriasis patients seen in Dr. Mehta's psoriasis clinic at the Penn Heart and Vascular Center, including nine patients with psoriatic arthritis. The baseline risk for these men and women averaged 7.3%, a low-risk level, but with the additional 6.2% risk added their functional risk jumped to an average of 13.5%, or to the intermediate-risk level. For individual patients, this signaled a substantial shift in their Framingham Risk Score risk level. Dr. Mehta conceded that the risk adjustment he applied derived from patients with severe psoriasis, while only 10% of patients in his practice have severe disease. About 60% have mild psoriasis, and about 30% have moderately severe disease, he said.

"This is the best we can do" for the time being, he said. "We applied the severe psoriasis metric to everyone to get a hazard estimate. We believe this is better than just multiplying" to recalculate a person's risk, the approach suggested by the EULAR committee. He hopes that a larger, prospective study he has begun in collaboration with Dr. Joel M. Gelfand, a dermatologist at the University of Pennsylvania and the senior investigator for this work, will eventually provide a more nuanced risk adjustment for all levels of psoriasis severity. But he said that the current estimate of the increased risk will help persuade psoriasis patients to adopt healthier lifestyles.  Patients with psoriasis, at all severity levels, tend to have relatively high rates of obesity, smoking, diabetes, hypertension, and inactivity.

Dr. Mehta added that better medical control of psoriasis also might help blunt the increased cardiovascular risk.

"Psoriasis and atherosclerosis are both T-cell mediated diseases," he observed. Most likely what goes on in the skin -to form the psoriasis plaques - also is going on inside patients' blood vessels, he said.

Dr. Mehta said that he had no disclosures. 

NEW ORLEANS – Patients with severe psoriasis face a 6% higher 10-year risk for a cardiovascular event than do comparable people without psoriasis, according to the findings of a prospective cohort study of nearly 18,000 people.

This added cardiovascular risk can have substantial implications, as it can move psoriasis patients into a higher Framingham Risk Score category and shift the way physicians need to think about cardiovascular risk management of these patients, Dr. Nehal N. Mehta said at the annual meeting of the American College of Cardiology.

In his practice that focuses on adults with psoriasis, the average background Framingham Risk Score based on low density lipoprotein cholesterol is a 7% 10-year risk for having a cardiovascular event, a level defined as low risk. However, adding the 6% additional risk linked with their psoriasis results in many patients having a 10-year risk of 13% or higher, placing them in the intermediate risk category (generally defined as a 10%-20% risk of having a cardiovascular event).

Patients at that intermediate risk category usually have more stringent targets for lipid levels, blood pressure, and weight although, in this context, it's unclear whether patients who leap into a higher cardiovascular risk level because of their psoriasis require more aggressive medical management; cardiovascular risk management guidelines have yet to elucidate optimal management for this patient subgroup.

Dr. Mehta deals with this dilemma by implementing aggressive lifestyle interventions for these patients, and also by suggesting naturally occurring risk-reduction interventions, such as the consumption of fiber, red yeast rice, soy, phytoestrogens, fish oil, and niacin. If, after all these interventions, a patient's low density lipoprotein cholesterol or blood pressure remains at a questionably high level, he discusses the option of starting treatment with a statin or an antihypertensive medication, making clear that these steps have not yet been endorsed by most society management guidelines.

"Ultimately, about 5% of my psoriasis patients end up on a statin," said Dr. Mehta, a cardiologist and director of the inflammatory risk clinic in preventive cardiology at the University of Pennsylvania, Philadelphia.

Dr. Mehta and his associates derived an estimate of cardiovascular disease risk attributable to psoriasis by reviewing follow-up data maintained on 3,603 patients with severe psoriasis and 14,330 control participants without psoriasis enrolled in the General Practice Research Database, a collection of records from more than 5 million people seen by U.K. general practice physicians. The researchers identified cases of severe psoriasis based on their receiving systemic therapy or phototherapy and excluded people with a prior history of cardiovascular events. The average age of all the people in the analysis was about 50 years and, on average, people were followed for about 3 years.

In a multivariable analysis that controlled for diabetes, hypertension, hyperlipidemia, age, gender, body mass index, and smoking status, the risk for a myocardial infarction, stroke, or death from a cardiovascular cause was 53% higher among the psoriasis patients, compared with the controls, a statistically significant difference. This higher cardiovascular risk among patients with psoriasis matched the 50% increased risk proposed last year for patients with rheumatoid arthritis and other forms of inflammatory arthritis including psoriatic arthritis, according to a panel convened by the European League Against Rheumatism (Ann. Rheum. Dis. 2010;69:325-31).

To translate the 1.53 relative risk into an attributable risk, Dr. Mehta and his associates multiplied that factor against the background cardiovascular risk for someone in the general population of the study to derive an adjusted risk. They then subtracted the background risk from the adjusted risk. Over a 10-year period, this translated into an excess risk for a cardiovascular event of 6.2%.

To illustrate the potential impact of this estimate, the researchers then applied this to a consecutive sample of 103 psoriasis patients seen in Dr. Mehta's psoriasis clinic at the Penn Heart and Vascular Center, including nine patients with psoriatic arthritis. The baseline risk for these men and women averaged 7.3%, a low-risk level, but with the additional 6.2% risk added their functional risk jumped to an average of 13.5%, or to the intermediate-risk level. For individual patients, this signaled a substantial shift in their Framingham Risk Score risk level. Dr. Mehta conceded that the risk adjustment he applied derived from patients with severe psoriasis, while only 10% of patients in his practice have severe disease. About 60% have mild psoriasis, and about 30% have moderately severe disease, he said.

"This is the best we can do" for the time being, he said. "We applied the severe psoriasis metric to everyone to get a hazard estimate. We believe this is better than just multiplying" to recalculate a person's risk, the approach suggested by the EULAR committee. He hopes that a larger, prospective study he has begun in collaboration with Dr. Joel M. Gelfand, a dermatologist at the University of Pennsylvania and the senior investigator for this work, will eventually provide a more nuanced risk adjustment for all levels of psoriasis severity. But he said that the current estimate of the increased risk will help persuade psoriasis patients to adopt healthier lifestyles.  Patients with psoriasis, at all severity levels, tend to have relatively high rates of obesity, smoking, diabetes, hypertension, and inactivity.

Dr. Mehta added that better medical control of psoriasis also might help blunt the increased cardiovascular risk.

"Psoriasis and atherosclerosis are both T-cell mediated diseases," he observed. Most likely what goes on in the skin -to form the psoriasis plaques - also is going on inside patients' blood vessels, he said.

Dr. Mehta said that he had no disclosures. 

NEW ORLEANS – Patients with severe psoriasis face a 6% higher 10-year risk for a cardiovascular event than do comparable people without psoriasis, according to the findings of a prospective cohort study of nearly 18,000 people.

This added cardiovascular risk can have substantial implications, as it can move psoriasis patients into a higher Framingham Risk Score category and shift the way physicians need to think about cardiovascular risk management of these patients, Dr. Nehal N. Mehta said at the annual meeting of the American College of Cardiology.

In his practice that focuses on adults with psoriasis, the average background Framingham Risk Score based on low density lipoprotein cholesterol is a 7% 10-year risk for having a cardiovascular event, a level defined as low risk. However, adding the 6% additional risk linked with their psoriasis results in many patients having a 10-year risk of 13% or higher, placing them in the intermediate risk category (generally defined as a 10%-20% risk of having a cardiovascular event).

Patients at that intermediate risk category usually have more stringent targets for lipid levels, blood pressure, and weight although, in this context, it's unclear whether patients who leap into a higher cardiovascular risk level because of their psoriasis require more aggressive medical management; cardiovascular risk management guidelines have yet to elucidate optimal management for this patient subgroup.

Dr. Mehta deals with this dilemma by implementing aggressive lifestyle interventions for these patients, and also by suggesting naturally occurring risk-reduction interventions, such as the consumption of fiber, red yeast rice, soy, phytoestrogens, fish oil, and niacin. If, after all these interventions, a patient's low density lipoprotein cholesterol or blood pressure remains at a questionably high level, he discusses the option of starting treatment with a statin or an antihypertensive medication, making clear that these steps have not yet been endorsed by most society management guidelines.

"Ultimately, about 5% of my psoriasis patients end up on a statin," said Dr. Mehta, a cardiologist and director of the inflammatory risk clinic in preventive cardiology at the University of Pennsylvania, Philadelphia.

Dr. Mehta and his associates derived an estimate of cardiovascular disease risk attributable to psoriasis by reviewing follow-up data maintained on 3,603 patients with severe psoriasis and 14,330 control participants without psoriasis enrolled in the General Practice Research Database, a collection of records from more than 5 million people seen by U.K. general practice physicians. The researchers identified cases of severe psoriasis based on their receiving systemic therapy or phototherapy and excluded people with a prior history of cardiovascular events. The average age of all the people in the analysis was about 50 years and, on average, people were followed for about 3 years.

In a multivariable analysis that controlled for diabetes, hypertension, hyperlipidemia, age, gender, body mass index, and smoking status, the risk for a myocardial infarction, stroke, or death from a cardiovascular cause was 53% higher among the psoriasis patients, compared with the controls, a statistically significant difference. This higher cardiovascular risk among patients with psoriasis matched the 50% increased risk proposed last year for patients with rheumatoid arthritis and other forms of inflammatory arthritis including psoriatic arthritis, according to a panel convened by the European League Against Rheumatism (Ann. Rheum. Dis. 2010;69:325-31).

To translate the 1.53 relative risk into an attributable risk, Dr. Mehta and his associates multiplied that factor against the background cardiovascular risk for someone in the general population of the study to derive an adjusted risk. They then subtracted the background risk from the adjusted risk. Over a 10-year period, this translated into an excess risk for a cardiovascular event of 6.2%.

To illustrate the potential impact of this estimate, the researchers then applied this to a consecutive sample of 103 psoriasis patients seen in Dr. Mehta's psoriasis clinic at the Penn Heart and Vascular Center, including nine patients with psoriatic arthritis. The baseline risk for these men and women averaged 7.3%, a low-risk level, but with the additional 6.2% risk added their functional risk jumped to an average of 13.5%, or to the intermediate-risk level. For individual patients, this signaled a substantial shift in their Framingham Risk Score risk level. Dr. Mehta conceded that the risk adjustment he applied derived from patients with severe psoriasis, while only 10% of patients in his practice have severe disease. About 60% have mild psoriasis, and about 30% have moderately severe disease, he said.

"This is the best we can do" for the time being, he said. "We applied the severe psoriasis metric to everyone to get a hazard estimate. We believe this is better than just multiplying" to recalculate a person's risk, the approach suggested by the EULAR committee. He hopes that a larger, prospective study he has begun in collaboration with Dr. Joel M. Gelfand, a dermatologist at the University of Pennsylvania and the senior investigator for this work, will eventually provide a more nuanced risk adjustment for all levels of psoriasis severity. But he said that the current estimate of the increased risk will help persuade psoriasis patients to adopt healthier lifestyles.  Patients with psoriasis, at all severity levels, tend to have relatively high rates of obesity, smoking, diabetes, hypertension, and inactivity.

Dr. Mehta added that better medical control of psoriasis also might help blunt the increased cardiovascular risk.

"Psoriasis and atherosclerosis are both T-cell mediated diseases," he observed. Most likely what goes on in the skin -to form the psoriasis plaques - also is going on inside patients' blood vessels, he said.

Dr. Mehta said that he had no disclosures. 

NEW ORLEANS – Patients with severe psoriasis face a 6% higher 10-year risk for a cardiovascular event than do comparable people without psoriasis, according to the findings of a prospective cohort study of nearly 18,000 people.

This added cardiovascular risk can have substantial implications, as it can move psoriasis patients into a higher Framingham Risk Score category and shift the way physicians need to think about cardiovascular risk management of these patients, Dr. Nehal N. Mehta said at the annual meeting of the American College of Cardiology.

In his practice that focuses on adults with psoriasis, the average background Framingham Risk Score based on low density lipoprotein cholesterol is a 7% 10-year risk for having a cardiovascular event, a level defined as low risk. However, adding the 6% additional risk linked with their psoriasis results in many patients having a 10-year risk of 13% or higher, placing them in the intermediate risk category (generally defined as a 10%-20% risk of having a cardiovascular event).

Patients at that intermediate risk category usually have more stringent targets for lipid levels, blood pressure, and weight although, in this context, it's unclear whether patients who leap into a higher cardiovascular risk level because of their psoriasis require more aggressive medical management; cardiovascular risk management guidelines have yet to elucidate optimal management for this patient subgroup.

Dr. Mehta deals with this dilemma by implementing aggressive lifestyle interventions for these patients, and also by suggesting naturally occurring risk-reduction interventions, such as the consumption of fiber, red yeast rice, soy, phytoestrogens, fish oil, and niacin. If, after all these interventions, a patient's low density lipoprotein cholesterol or blood pressure remains at a questionably high level, he discusses the option of starting treatment with a statin or an antihypertensive medication, making clear that these steps have not yet been endorsed by most society management guidelines.

"Ultimately, about 5% of my psoriasis patients end up on a statin," said Dr. Mehta, a cardiologist and director of the inflammatory risk clinic in preventive cardiology at the University of Pennsylvania, Philadelphia.

Dr. Mehta and his associates derived an estimate of cardiovascular disease risk attributable to psoriasis by reviewing follow-up data maintained on 3,603 patients with severe psoriasis and 14,330 control participants without psoriasis enrolled in the General Practice Research Database, a collection of records from more than 5 million people seen by U.K. general practice physicians. The researchers identified cases of severe psoriasis based on their receiving systemic therapy or phototherapy and excluded people with a prior history of cardiovascular events. The average age of all the people in the analysis was about 50 years and, on average, people were followed for about 3 years.

In a multivariable analysis that controlled for diabetes, hypertension, hyperlipidemia, age, gender, body mass index, and smoking status, the risk for a myocardial infarction, stroke, or death from a cardiovascular cause was 53% higher among the psoriasis patients, compared with the controls, a statistically significant difference. This higher cardiovascular risk among patients with psoriasis matched the 50% increased risk proposed last year for patients with rheumatoid arthritis and other forms of inflammatory arthritis including psoriatic arthritis, according to a panel convened by the European League Against Rheumatism (Ann. Rheum. Dis. 2010;69:325-31).

To translate the 1.53 relative risk into an attributable risk, Dr. Mehta and his associates multiplied that factor against the background cardiovascular risk for someone in the general population of the study to derive an adjusted risk. They then subtracted the background risk from the adjusted risk. Over a 10-year period, this translated into an excess risk for a cardiovascular event of 6.2%.

To illustrate the potential impact of this estimate, the researchers then applied this to a consecutive sample of 103 psoriasis patients seen in Dr. Mehta's psoriasis clinic at the Penn Heart and Vascular Center, including nine patients with psoriatic arthritis. The baseline risk for these men and women averaged 7.3%, a low-risk level, but with the additional 6.2% risk added their functional risk jumped to an average of 13.5%, or to the intermediate-risk level. For individual patients, this signaled a substantial shift in their Framingham Risk Score risk level. Dr. Mehta conceded that the risk adjustment he applied derived from patients with severe psoriasis, while only 10% of patients in his practice have severe disease. About 60% have mild psoriasis, and about 30% have moderately severe disease, he said.

"This is the best we can do" for the time being, he said. "We applied the severe psoriasis metric to everyone to get a hazard estimate. We believe this is better than just multiplying" to recalculate a person's risk, the approach suggested by the EULAR committee. He hopes that a larger, prospective study he has begun in collaboration with Dr. Joel M. Gelfand, a dermatologist at the University of Pennsylvania and the senior investigator for this work, will eventually provide a more nuanced risk adjustment for all levels of psoriasis severity. But he said that the current estimate of the increased risk will help persuade psoriasis patients to adopt healthier lifestyles.  Patients with psoriasis, at all severity levels, tend to have relatively high rates of obesity, smoking, diabetes, hypertension, and inactivity.

Dr. Mehta added that better medical control of psoriasis also might help blunt the increased cardiovascular risk.

"Psoriasis and atherosclerosis are both T-cell mediated diseases," he observed. Most likely what goes on in the skin -to form the psoriasis plaques - also is going on inside patients' blood vessels, he said.

Dr. Mehta said that he had no disclosures. 

NEW ORLEANS – Patients with severe psoriasis face a 6% higher 10-year risk for a cardiovascular event than do comparable people without psoriasis, according to the findings of a prospective cohort study of nearly 18,000 people.

This added cardiovascular risk can have substantial implications, as it can move psoriasis patients into a higher Framingham Risk Score category and shift the way physicians need to think about cardiovascular risk management of these patients, Dr. Nehal N. Mehta said at the annual meeting of the American College of Cardiology.

In his practice that focuses on adults with psoriasis, the average background Framingham Risk Score based on low density lipoprotein cholesterol is a 7% 10-year risk for having a cardiovascular event, a level defined as low risk. However, adding the 6% additional risk linked with their psoriasis results in many patients having a 10-year risk of 13% or higher, placing them in the intermediate risk category (generally defined as a 10%-20% risk of having a cardiovascular event).

Patients at that intermediate risk category usually have more stringent targets for lipid levels, blood pressure, and weight although, in this context, it's unclear whether patients who leap into a higher cardiovascular risk level because of their psoriasis require more aggressive medical management; cardiovascular risk management guidelines have yet to elucidate optimal management for this patient subgroup.

Dr. Mehta deals with this dilemma by implementing aggressive lifestyle interventions for these patients, and also by suggesting naturally occurring risk-reduction interventions, such as the consumption of fiber, red yeast rice, soy, phytoestrogens, fish oil, and niacin. If, after all these interventions, a patient's low density lipoprotein cholesterol or blood pressure remains at a questionably high level, he discusses the option of starting treatment with a statin or an antihypertensive medication, making clear that these steps have not yet been endorsed by most society management guidelines.

"Ultimately, about 5% of my psoriasis patients end up on a statin," said Dr. Mehta, a cardiologist and director of the inflammatory risk clinic in preventive cardiology at the University of Pennsylvania, Philadelphia.

Dr. Mehta and his associates derived an estimate of cardiovascular disease risk attributable to psoriasis by reviewing follow-up data maintained on 3,603 patients with severe psoriasis and 14,330 control participants without psoriasis enrolled in the General Practice Research Database, a collection of records from more than 5 million people seen by U.K. general practice physicians. The researchers identified cases of severe psoriasis based on their receiving systemic therapy or phototherapy and excluded people with a prior history of cardiovascular events. The average age of all the people in the analysis was about 50 years and, on average, people were followed for about 3 years.

In a multivariable analysis that controlled for diabetes, hypertension, hyperlipidemia, age, gender, body mass index, and smoking status, the risk for a myocardial infarction, stroke, or death from a cardiovascular cause was 53% higher among the psoriasis patients, compared with the controls, a statistically significant difference. This higher cardiovascular risk among patients with psoriasis matched the 50% increased risk proposed last year for patients with rheumatoid arthritis and other forms of inflammatory arthritis including psoriatic arthritis, according to a panel convened by the European League Against Rheumatism (Ann. Rheum. Dis. 2010;69:325-31).

To translate the 1.53 relative risk into an attributable risk, Dr. Mehta and his associates multiplied that factor against the background cardiovascular risk for someone in the general population of the study to derive an adjusted risk. They then subtracted the background risk from the adjusted risk. Over a 10-year period, this translated into an excess risk for a cardiovascular event of 6.2%.

To illustrate the potential impact of this estimate, the researchers then applied this to a consecutive sample of 103 psoriasis patients seen in Dr. Mehta's psoriasis clinic at the Penn Heart and Vascular Center, including nine patients with psoriatic arthritis. The baseline risk for these men and women averaged 7.3%, a low-risk level, but with the additional 6.2% risk added their functional risk jumped to an average of 13.5%, or to the intermediate-risk level. For individual patients, this signaled a substantial shift in their Framingham Risk Score risk level. Dr. Mehta conceded that the risk adjustment he applied derived from patients with severe psoriasis, while only 10% of patients in his practice have severe disease. About 60% have mild psoriasis, and about 30% have moderately severe disease, he said.

"This is the best we can do" for the time being, he said. "We applied the severe psoriasis metric to everyone to get a hazard estimate. We believe this is better than just multiplying" to recalculate a person's risk, the approach suggested by the EULAR committee. He hopes that a larger, prospective study he has begun in collaboration with Dr. Joel M. Gelfand, a dermatologist at the University of Pennsylvania and the senior investigator for this work, will eventually provide a more nuanced risk adjustment for all levels of psoriasis severity. But he said that the current estimate of the increased risk will help persuade psoriasis patients to adopt healthier lifestyles.  Patients with psoriasis, at all severity levels, tend to have relatively high rates of obesity, smoking, diabetes, hypertension, and inactivity.

Dr. Mehta added that better medical control of psoriasis also might help blunt the increased cardiovascular risk.

"Psoriasis and atherosclerosis are both T-cell mediated diseases," he observed. Most likely what goes on in the skin -to form the psoriasis plaques - also is going on inside patients' blood vessels, he said.

Dr. Mehta said that he had no disclosures. 

NEW ORLEANS – Patients with severe psoriasis face a 6% higher 10-year risk for a cardiovascular event than do comparable people without psoriasis, according to the findings of a prospective cohort study of nearly 18,000 people.

This added cardiovascular risk can have substantial implications, as it can move psoriasis patients into a higher Framingham Risk Score category and shift the way physicians need to think about cardiovascular risk management of these patients, Dr. Nehal N. Mehta said at the annual meeting of the American College of Cardiology.

In his practice that focuses on adults with psoriasis, the average background Framingham Risk Score based on low density lipoprotein cholesterol is a 7% 10-year risk for having a cardiovascular event, a level defined as low risk. However, adding the 6% additional risk linked with their psoriasis results in many patients having a 10-year risk of 13% or higher, placing them in the intermediate risk category (generally defined as a 10%-20% risk of having a cardiovascular event).

Patients at that intermediate risk category usually have more stringent targets for lipid levels, blood pressure, and weight although, in this context, it's unclear whether patients who leap into a higher cardiovascular risk level because of their psoriasis require more aggressive medical management; cardiovascular risk management guidelines have yet to elucidate optimal management for this patient subgroup.

Dr. Mehta deals with this dilemma by implementing aggressive lifestyle interventions for these patients, and also by suggesting naturally occurring risk-reduction interventions, such as the consumption of fiber, red yeast rice, soy, phytoestrogens, fish oil, and niacin. If, after all these interventions, a patient's low density lipoprotein cholesterol or blood pressure remains at a questionably high level, he discusses the option of starting treatment with a statin or an antihypertensive medication, making clear that these steps have not yet been endorsed by most society management guidelines.

"Ultimately, about 5% of my psoriasis patients end up on a statin," said Dr. Mehta, a cardiologist and director of the inflammatory risk clinic in preventive cardiology at the University of Pennsylvania, Philadelphia.

Dr. Mehta and his associates derived an estimate of cardiovascular disease risk attributable to psoriasis by reviewing follow-up data maintained on 3,603 patients with severe psoriasis and 14,330 control participants without psoriasis enrolled in the General Practice Research Database, a collection of records from more than 5 million people seen by U.K. general practice physicians. The researchers identified cases of severe psoriasis based on their receiving systemic therapy or phototherapy and excluded people with a prior history of cardiovascular events. The average age of all the people in the analysis was about 50 years and, on average, people were followed for about 3 years.

In a multivariable analysis that controlled for diabetes, hypertension, hyperlipidemia, age, gender, body mass index, and smoking status, the risk for a myocardial infarction, stroke, or death from a cardiovascular cause was 53% higher among the psoriasis patients, compared with the controls, a statistically significant difference. This higher cardiovascular risk among patients with psoriasis matched the 50% increased risk proposed last year for patients with rheumatoid arthritis and other forms of inflammatory arthritis including psoriatic arthritis, according to a panel convened by the European League Against Rheumatism (Ann. Rheum. Dis. 2010;69:325-31).

To translate the 1.53 relative risk into an attributable risk, Dr. Mehta and his associates multiplied that factor against the background cardiovascular risk for someone in the general population of the study to derive an adjusted risk. They then subtracted the background risk from the adjusted risk. Over a 10-year period, this translated into an excess risk for a cardiovascular event of 6.2%.

To illustrate the potential impact of this estimate, the researchers then applied this to a consecutive sample of 103 psoriasis patients seen in Dr. Mehta's psoriasis clinic at the Penn Heart and Vascular Center, including nine patients with psoriatic arthritis. The baseline risk for these men and women averaged 7.3%, a low-risk level, but with the additional 6.2% risk added their functional risk jumped to an average of 13.5%, or to the intermediate-risk level. For individual patients, this signaled a substantial shift in their Framingham Risk Score risk level. Dr. Mehta conceded that the risk adjustment he applied derived from patients with severe psoriasis, while only 10% of patients in his practice have severe disease. About 60% have mild psoriasis, and about 30% have moderately severe disease, he said.

"This is the best we can do" for the time being, he said. "We applied the severe psoriasis metric to everyone to get a hazard estimate. We believe this is better than just multiplying" to recalculate a person's risk, the approach suggested by the EULAR committee. He hopes that a larger, prospective study he has begun in collaboration with Dr. Joel M. Gelfand, a dermatologist at the University of Pennsylvania and the senior investigator for this work, will eventually provide a more nuanced risk adjustment for all levels of psoriasis severity. But he said that the current estimate of the increased risk will help persuade psoriasis patients to adopt healthier lifestyles.  Patients with psoriasis, at all severity levels, tend to have relatively high rates of obesity, smoking, diabetes, hypertension, and inactivity.

Dr. Mehta added that better medical control of psoriasis also might help blunt the increased cardiovascular risk.

"Psoriasis and atherosclerosis are both T-cell mediated diseases," he observed. Most likely what goes on in the skin -to form the psoriasis plaques - also is going on inside patients' blood vessels, he said.

Dr. Mehta said that he had no disclosures. 

PHILADELPHIA  – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said at the annual meeting of the Eastern Society for Pediatric Research.

"Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections," said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

"People have been saying that maybe we should culture pregnant women" to determine whether they have anovaginal S. aureus colonization, "but it’s a huge expense, and you’d have to really convince yourself that it matters," said Dr. Lisa Saiman, a professor of clinical pediatrics at the university, an attending physician and hospital epidemiologist at New York-Presbyterian, and a collaborator on the study. "S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don’t want people to worry about what’s normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora" she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35-37 weeks’ gestation.

Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization.

Dr. Top’s analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days (range 3-66 days).

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold.

In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Mode of delivery also played a role, with women who had a caesarean delivery significantly more likely to become infected than women with a vaginal delivery.

Dr. Top and Dr. Saiman said that they had no relevant financial disclosures.

PHILADELPHIA  – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said at the annual meeting of the Eastern Society for Pediatric Research.

"Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections," said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

"People have been saying that maybe we should culture pregnant women" to determine whether they have anovaginal S. aureus colonization, "but it’s a huge expense, and you’d have to really convince yourself that it matters," said Dr. Lisa Saiman, a professor of clinical pediatrics at the university, an attending physician and hospital epidemiologist at New York-Presbyterian, and a collaborator on the study. "S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don’t want people to worry about what’s normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora" she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35-37 weeks’ gestation.

Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization.

Dr. Top’s analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days (range 3-66 days).

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold.

In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Mode of delivery also played a role, with women who had a caesarean delivery significantly more likely to become infected than women with a vaginal delivery.

Dr. Top and Dr. Saiman said that they had no relevant financial disclosures.

PHILADELPHIA  – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said at the annual meeting of the Eastern Society for Pediatric Research.

"Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections," said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

"People have been saying that maybe we should culture pregnant women" to determine whether they have anovaginal S. aureus colonization, "but it’s a huge expense, and you’d have to really convince yourself that it matters," said Dr. Lisa Saiman, a professor of clinical pediatrics at the university, an attending physician and hospital epidemiologist at New York-Presbyterian, and a collaborator on the study. "S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don’t want people to worry about what’s normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora" she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35-37 weeks’ gestation.

Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization.

Dr. Top’s analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days (range 3-66 days).

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold.

In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Mode of delivery also played a role, with women who had a caesarean delivery significantly more likely to become infected than women with a vaginal delivery.

Dr. Top and Dr. Saiman said that they had no relevant financial disclosures.

PHILADELPHIA  – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said at the annual meeting of the Eastern Society for Pediatric Research.

"Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections," said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

"People have been saying that maybe we should culture pregnant women" to determine whether they have anovaginal S. aureus colonization, "but it’s a huge expense, and you’d have to really convince yourself that it matters," said Dr. Lisa Saiman, a professor of clinical pediatrics at the university, an attending physician and hospital epidemiologist at New York-Presbyterian, and a collaborator on the study. "S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don’t want people to worry about what’s normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora" she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35-37 weeks’ gestation.

Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization.

Dr. Top’s analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days (range 3-66 days).

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold.

In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Mode of delivery also played a role, with women who had a caesarean delivery significantly more likely to become infected than women with a vaginal delivery.

Dr. Top and Dr. Saiman said that they had no relevant financial disclosures.

PHILADELPHIA  – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said at the annual meeting of the Eastern Society for Pediatric Research.

"Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections," said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

"People have been saying that maybe we should culture pregnant women" to determine whether they have anovaginal S. aureus colonization, "but it’s a huge expense, and you’d have to really convince yourself that it matters," said Dr. Lisa Saiman, a professor of clinical pediatrics at the university, an attending physician and hospital epidemiologist at New York-Presbyterian, and a collaborator on the study. "S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don’t want people to worry about what’s normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora" she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35-37 weeks’ gestation.

Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization.

Dr. Top’s analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days (range 3-66 days).

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold.

In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Mode of delivery also played a role, with women who had a caesarean delivery significantly more likely to become infected than women with a vaginal delivery.

Dr. Top and Dr. Saiman said that they had no relevant financial disclosures.

PHILADELPHIA  – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said at the annual meeting of the Eastern Society for Pediatric Research.

"Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections," said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

"People have been saying that maybe we should culture pregnant women" to determine whether they have anovaginal S. aureus colonization, "but it’s a huge expense, and you’d have to really convince yourself that it matters," said Dr. Lisa Saiman, a professor of clinical pediatrics at the university, an attending physician and hospital epidemiologist at New York-Presbyterian, and a collaborator on the study. "S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don’t want people to worry about what’s normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora" she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35-37 weeks’ gestation.

Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization.

Dr. Top’s analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days (range 3-66 days).

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold.

In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Mode of delivery also played a role, with women who had a caesarean delivery significantly more likely to become infected than women with a vaginal delivery.

Dr. Top and Dr. Saiman said that they had no relevant financial disclosures.

PHILADELPHIA  – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said at the annual meeting of the Eastern Society for Pediatric Research.

"Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections," said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

"People have been saying that maybe we should culture pregnant women" to determine whether they have anovaginal S. aureus colonization, "but it’s a huge expense, and you’d have to really convince yourself that it matters," said Dr. Lisa Saiman, a professor of clinical pediatrics at the university, an attending physician and hospital epidemiologist at New York-Presbyterian, and a collaborator on the study. "S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don’t want people to worry about what’s normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora" she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35-37 weeks’ gestation.

Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization.

Dr. Top’s analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days (range 3-66 days).

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold.

In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Mode of delivery also played a role, with women who had a caesarean delivery significantly more likely to become infected than women with a vaginal delivery.

Dr. Top and Dr. Saiman said that they had no relevant financial disclosures.

PHILADELPHIA  – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said at the annual meeting of the Eastern Society for Pediatric Research.

"Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections," said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

"People have been saying that maybe we should culture pregnant women" to determine whether they have anovaginal S. aureus colonization, "but it’s a huge expense, and you’d have to really convince yourself that it matters," said Dr. Lisa Saiman, a professor of clinical pediatrics at the university, an attending physician and hospital epidemiologist at New York-Presbyterian, and a collaborator on the study. "S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don’t want people to worry about what’s normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora" she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35-37 weeks’ gestation.

Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization.

Dr. Top’s analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days (range 3-66 days).

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold.

In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Mode of delivery also played a role, with women who had a caesarean delivery significantly more likely to become infected than women with a vaginal delivery.

Dr. Top and Dr. Saiman said that they had no relevant financial disclosures.

PHILADELPHIA  – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said at the annual meeting of the Eastern Society for Pediatric Research.

"Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections," said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

"People have been saying that maybe we should culture pregnant women" to determine whether they have anovaginal S. aureus colonization, "but it’s a huge expense, and you’d have to really convince yourself that it matters," said Dr. Lisa Saiman, a professor of clinical pediatrics at the university, an attending physician and hospital epidemiologist at New York-Presbyterian, and a collaborator on the study. "S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don’t want people to worry about what’s normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora" she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35-37 weeks’ gestation.

Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization.

Dr. Top’s analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days (range 3-66 days).

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold.

In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Mode of delivery also played a role, with women who had a caesarean delivery significantly more likely to become infected than women with a vaginal delivery.

Dr. Top and Dr. Saiman said that they had no relevant financial disclosures.

NEW ORLEANS – Presuming that the Resolute zotarolimus-eluting coronary stent enters the U.S. market within the next year, interventionalists likely will rely on data from two key studies to weigh how it matches up against its main competition, the Xience V/Promus everolimus-eluting coronary stent.

Two features seemed to especially capture the attention of the cardiologists who reported the data at the annual meeting of the American College of Cardiology and those who heard it: the impressive performance of the zotarolimus-eluting stent (ZES) in patients with diabetes, and the long-term safety of the ZES compared with the everolimus-eluting stent (EES) for stent thrombosis.

The two studies included the RESOLUTE All Comers trial, which compared the ZES against the EES in a randomized trial of 2,292 European patients for whom follow-up now extends to 2 years. The second study, RESOLUTE US, evaluated the new ZES in a series of 1,402 U.S. patients with a high, 34% prevalence of diabetes; this study had a special focus on the stent’s performance in the 150 narrow, 2.25-mm-diameter arteries included in the series.

The roughly 2,500 ZES recipients included in these two studies form about half of the 5,227 total patient worldwide experience with the stent to date, and constituted what Medronic, the company developing the Resolute ZES, submitted to the Food and Drug Administration on April 1 for marketing approval and labeling.

One major take on these data by experts was that the ZES showed good overall performance that matched well with the performance of the EES.

"I think Xience/Promus and Resolute represent the state of the art for current-generation drug-eluting stents. Choosing between them would be very difficult. They seemed to be fairly equivalent for most of the important safety and efficacy metrics. They are both superb," said Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy at Columbia University in New York, and lead investigator for the RESOLUTE US study.

But other interventionalists hearing the data from both studies weren’t as completely convinced.

"My initial take on the data is that [the ZES] doesn’t seem to be better than the Xience stent, which is a very good stent and the dominant stent we use [in the United States] at this time," commented Dr. Abhiram Prasad, an interventional cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn. "Solely on the basis of these data, I don’t think I would foresee a major shift in our use of the Xience stent," he said in an interview.

Safety concerns with the ZES date back to the initial, 12-month follow-up report, the first indication that the ZES fell short, compared with the EES on the rate of stent thrombosis in the RESOLUTE All Comers trial. The New England Journal of Medicine report last year documented 18 patients (1.6%) with definite or probable stent thrombosis in the ZES arm, compared with 8 cases (0.7%) of definite or probable stent thrombosis in the EES group, a significant difference (N. Engl. J. Med. 2010;363:136-46).

The new, 24-month follow-up data provided some reassurance on safety, in that the stent thrombosis gap between the two stents stayed stable. During an extra year of follow-up, three new cases of definite or probable stent thrombosis occurred in each of the two treatment arms, said Dr. Patrick W. Serruys, professor of interventional cardiology at Erasmus University and the Thoraxcentrum, Rotterdam, and lead investigator for the RESOLUTE All Comers trial. Aside from this one early safety deviation, the ZES and EES continued to show virtually identical efficacy performance through the 2 years of study, he showed in the updated data. Concurrently with his report at the meeting, the results appeared in an article published in the Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

Dr. Serruys, as well as others, chalked up the early difference in stent thrombosis rates to chance, and to some isolated poor performance in certain sites undertaking the coronary interventions.

"Numerically, the stent thrombosis is very small, a difference of 21 versus 11 patients in more than 2,000 total patients. It could be the play of chance," Dr. Serruys said.

The RESOLUTE US results seemed to add to the safety assurance. In those 1,402 patients, 2 cases (0.1%) of stent thrombosis occurred during 12 months of tracking. Concurrently with Dr. Leon’s report, the RESOLUTE US results appeared in an article in the Journal of the American College of Cardiology (J. Amer. Coll. Cardiol. 2011 April 4 [doi:10.1016/j.jacc.2011.03.005]).

"This is one of the lowest 1-year stent thrombosis rates ever reported," noted Dr. Leon. "I take from this that it’s a safe stent. There was anxiety when RESOLUTE All Comers suggested a higher than expected stent thrombosis rate compared with Xience. The [RESOLUTE US] data help us realize that we need data density to get our hands around stent thrombosis. I’m not sure that 0.1% is the correct number either. By chance you’ll see study variations."

The pattern of some of the earliest cases of stent thrombosis in RESOLUTE All Comers suggested that it may have been caused more by operator failings and less by problems with the stent itself. During the study’s first 30 days, stent thrombosis occurred in nine ZES patients and one EES patient, making up most of the differential that wound up haunting the ZES arm through the next 2 years. "Stent thrombosis during the first 30 days is procedure related," and generally the stent itself plays no role, said Dr. Alan C. Yeung, professor of medicine and director of cardiac catheterization at Stanford (Calif.) University in Palo Alto.

"Whether it’s a real difference or a play of chance remains undetermined," commented Dr. Mitchell W. Krucoff, a professor of medicine and interventional cardiologist at Duke University in Durham, N.C. "These types of differences [21 patients versus 11 patients] are not certain at a statistical level." He called the question of a safety difference between the two stents "an open question," adding that "all the rest is superimposable" between the ZES and EES.

So if the ZES hopes to wrest any market share from the EES when it hits the U.S. market, it may need to have something to distinguish it, and that something may be an FDA-approved indication for treatment of coronary stenoses in patients with diabetes. At least that’s what Medtronic is hoping for. The company included that application in its submission to the FDA, Jason Fontana, Ph.D., senior director for clinical communication at Medtronic, said in an interview. If the ZES gets this indication, it will make the device unique. No other coronary stent now on the U.S. market carries that indication in its label.

"The diabetes subgroup was large enough, and the diabetes analysis was prespecified" in RESOLUTE US, Dr. Leon said in an interview. "If you include this subgroup, and the RESOLUTE All Comers diabetes subgroup, you have a robust enough population to justify consideration for approval, I think," he said.

"The results were quite substantial," with a 3.0% rate of target-lesion revascularization among the patients with diabetes, compared with a 2.0% rate for the entire main cohort of the study. "Usually you see more of a bump in patients with diabetes," he said. "To see a 3% repeat revascularization rate in patients with diabetes is very encouraging. I think if the stent gets this indication it may have an impact. It’s an important consideration."

But even if the diabetes indication works out, will interventionalists be swayed by that, or by the data?

"An issue is, to what extent can a single trial address a subgroup?" said Dr. Krucoff. "To what degree is there statistical guidance that in the real world [the ZES] would live up to this measure?"

"I don’t think I’d put a lot of emphasis of my decision-making on the [RESOLUTE US] data, because a problem with all [stenting] studies is that the rates are constantly improving, so the new device can appear to be better," said Dr. Prasad. "The study did not use a SYNTAX score to give us an idea of how complex the patients were. Unless we know about the complexity of the disease in the diabetes patients, I’m not sure we can call it a superior performance than what one would expect in today’s practice. Even if [the ZES] was approved for use in patients with diabetes, I don’t think in my practice I’d pick it to use in those patients. They’d need to do a randomized study in patients with diabetes to convince me" that it was better than the EES, Dr. Prasad said.

Dr. Serruys said he had no disclosures. Dr. Prasad said he had no disclosures. Dr. Leon said that he serves as an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Yeung said that he serves on the scientific advisory board of Medtronic; he is also a consultant for Abbott Vascular, Boston Scientific, and Cordis, and has received research grants from Boston Scientific, Edwards, and Medtronic. Dr. Fontana is an employee of Medtronic. Dr. Krucoff said that he has been a consultant to or has received honoraria from Abbott, Biosensors, Cardiomind, Cordis Johnson & Johnson, Medtronic, Merck, Micelle, OrbusNeich, Prescient, Sanofi-Aventis, and Terumo.

NEW ORLEANS – Presuming that the Resolute zotarolimus-eluting coronary stent enters the U.S. market within the next year, interventionalists likely will rely on data from two key studies to weigh how it matches up against its main competition, the Xience V/Promus everolimus-eluting coronary stent.

Two features seemed to especially capture the attention of the cardiologists who reported the data at the annual meeting of the American College of Cardiology and those who heard it: the impressive performance of the zotarolimus-eluting stent (ZES) in patients with diabetes, and the long-term safety of the ZES compared with the everolimus-eluting stent (EES) for stent thrombosis.

The two studies included the RESOLUTE All Comers trial, which compared the ZES against the EES in a randomized trial of 2,292 European patients for whom follow-up now extends to 2 years. The second study, RESOLUTE US, evaluated the new ZES in a series of 1,402 U.S. patients with a high, 34% prevalence of diabetes; this study had a special focus on the stent’s performance in the 150 narrow, 2.25-mm-diameter arteries included in the series.

The roughly 2,500 ZES recipients included in these two studies form about half of the 5,227 total patient worldwide experience with the stent to date, and constituted what Medronic, the company developing the Resolute ZES, submitted to the Food and Drug Administration on April 1 for marketing approval and labeling.

One major take on these data by experts was that the ZES showed good overall performance that matched well with the performance of the EES.

"I think Xience/Promus and Resolute represent the state of the art for current-generation drug-eluting stents. Choosing between them would be very difficult. They seemed to be fairly equivalent for most of the important safety and efficacy metrics. They are both superb," said Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy at Columbia University in New York, and lead investigator for the RESOLUTE US study.

But other interventionalists hearing the data from both studies weren’t as completely convinced.

"My initial take on the data is that [the ZES] doesn’t seem to be better than the Xience stent, which is a very good stent and the dominant stent we use [in the United States] at this time," commented Dr. Abhiram Prasad, an interventional cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn. "Solely on the basis of these data, I don’t think I would foresee a major shift in our use of the Xience stent," he said in an interview.

Safety concerns with the ZES date back to the initial, 12-month follow-up report, the first indication that the ZES fell short, compared with the EES on the rate of stent thrombosis in the RESOLUTE All Comers trial. The New England Journal of Medicine report last year documented 18 patients (1.6%) with definite or probable stent thrombosis in the ZES arm, compared with 8 cases (0.7%) of definite or probable stent thrombosis in the EES group, a significant difference (N. Engl. J. Med. 2010;363:136-46).

The new, 24-month follow-up data provided some reassurance on safety, in that the stent thrombosis gap between the two stents stayed stable. During an extra year of follow-up, three new cases of definite or probable stent thrombosis occurred in each of the two treatment arms, said Dr. Patrick W. Serruys, professor of interventional cardiology at Erasmus University and the Thoraxcentrum, Rotterdam, and lead investigator for the RESOLUTE All Comers trial. Aside from this one early safety deviation, the ZES and EES continued to show virtually identical efficacy performance through the 2 years of study, he showed in the updated data. Concurrently with his report at the meeting, the results appeared in an article published in the Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

Dr. Serruys, as well as others, chalked up the early difference in stent thrombosis rates to chance, and to some isolated poor performance in certain sites undertaking the coronary interventions.

"Numerically, the stent thrombosis is very small, a difference of 21 versus 11 patients in more than 2,000 total patients. It could be the play of chance," Dr. Serruys said.

The RESOLUTE US results seemed to add to the safety assurance. In those 1,402 patients, 2 cases (0.1%) of stent thrombosis occurred during 12 months of tracking. Concurrently with Dr. Leon’s report, the RESOLUTE US results appeared in an article in the Journal of the American College of Cardiology (J. Amer. Coll. Cardiol. 2011 April 4 [doi:10.1016/j.jacc.2011.03.005]).

"This is one of the lowest 1-year stent thrombosis rates ever reported," noted Dr. Leon. "I take from this that it’s a safe stent. There was anxiety when RESOLUTE All Comers suggested a higher than expected stent thrombosis rate compared with Xience. The [RESOLUTE US] data help us realize that we need data density to get our hands around stent thrombosis. I’m not sure that 0.1% is the correct number either. By chance you’ll see study variations."

The pattern of some of the earliest cases of stent thrombosis in RESOLUTE All Comers suggested that it may have been caused more by operator failings and less by problems with the stent itself. During the study’s first 30 days, stent thrombosis occurred in nine ZES patients and one EES patient, making up most of the differential that wound up haunting the ZES arm through the next 2 years. "Stent thrombosis during the first 30 days is procedure related," and generally the stent itself plays no role, said Dr. Alan C. Yeung, professor of medicine and director of cardiac catheterization at Stanford (Calif.) University in Palo Alto.

"Whether it’s a real difference or a play of chance remains undetermined," commented Dr. Mitchell W. Krucoff, a professor of medicine and interventional cardiologist at Duke University in Durham, N.C. "These types of differences [21 patients versus 11 patients] are not certain at a statistical level." He called the question of a safety difference between the two stents "an open question," adding that "all the rest is superimposable" between the ZES and EES.

So if the ZES hopes to wrest any market share from the EES when it hits the U.S. market, it may need to have something to distinguish it, and that something may be an FDA-approved indication for treatment of coronary stenoses in patients with diabetes. At least that’s what Medtronic is hoping for. The company included that application in its submission to the FDA, Jason Fontana, Ph.D., senior director for clinical communication at Medtronic, said in an interview. If the ZES gets this indication, it will make the device unique. No other coronary stent now on the U.S. market carries that indication in its label.

"The diabetes subgroup was large enough, and the diabetes analysis was prespecified" in RESOLUTE US, Dr. Leon said in an interview. "If you include this subgroup, and the RESOLUTE All Comers diabetes subgroup, you have a robust enough population to justify consideration for approval, I think," he said.

"The results were quite substantial," with a 3.0% rate of target-lesion revascularization among the patients with diabetes, compared with a 2.0% rate for the entire main cohort of the study. "Usually you see more of a bump in patients with diabetes," he said. "To see a 3% repeat revascularization rate in patients with diabetes is very encouraging. I think if the stent gets this indication it may have an impact. It’s an important consideration."

But even if the diabetes indication works out, will interventionalists be swayed by that, or by the data?

"An issue is, to what extent can a single trial address a subgroup?" said Dr. Krucoff. "To what degree is there statistical guidance that in the real world [the ZES] would live up to this measure?"

"I don’t think I’d put a lot of emphasis of my decision-making on the [RESOLUTE US] data, because a problem with all [stenting] studies is that the rates are constantly improving, so the new device can appear to be better," said Dr. Prasad. "The study did not use a SYNTAX score to give us an idea of how complex the patients were. Unless we know about the complexity of the disease in the diabetes patients, I’m not sure we can call it a superior performance than what one would expect in today’s practice. Even if [the ZES] was approved for use in patients with diabetes, I don’t think in my practice I’d pick it to use in those patients. They’d need to do a randomized study in patients with diabetes to convince me" that it was better than the EES, Dr. Prasad said.

Dr. Serruys said he had no disclosures. Dr. Prasad said he had no disclosures. Dr. Leon said that he serves as an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Yeung said that he serves on the scientific advisory board of Medtronic; he is also a consultant for Abbott Vascular, Boston Scientific, and Cordis, and has received research grants from Boston Scientific, Edwards, and Medtronic. Dr. Fontana is an employee of Medtronic. Dr. Krucoff said that he has been a consultant to or has received honoraria from Abbott, Biosensors, Cardiomind, Cordis Johnson & Johnson, Medtronic, Merck, Micelle, OrbusNeich, Prescient, Sanofi-Aventis, and Terumo.

NEW ORLEANS – Presuming that the Resolute zotarolimus-eluting coronary stent enters the U.S. market within the next year, interventionalists likely will rely on data from two key studies to weigh how it matches up against its main competition, the Xience V/Promus everolimus-eluting coronary stent.

Two features seemed to especially capture the attention of the cardiologists who reported the data at the annual meeting of the American College of Cardiology and those who heard it: the impressive performance of the zotarolimus-eluting stent (ZES) in patients with diabetes, and the long-term safety of the ZES compared with the everolimus-eluting stent (EES) for stent thrombosis.

The two studies included the RESOLUTE All Comers trial, which compared the ZES against the EES in a randomized trial of 2,292 European patients for whom follow-up now extends to 2 years. The second study, RESOLUTE US, evaluated the new ZES in a series of 1,402 U.S. patients with a high, 34% prevalence of diabetes; this study had a special focus on the stent’s performance in the 150 narrow, 2.25-mm-diameter arteries included in the series.

The roughly 2,500 ZES recipients included in these two studies form about half of the 5,227 total patient worldwide experience with the stent to date, and constituted what Medronic, the company developing the Resolute ZES, submitted to the Food and Drug Administration on April 1 for marketing approval and labeling.

One major take on these data by experts was that the ZES showed good overall performance that matched well with the performance of the EES.

"I think Xience/Promus and Resolute represent the state of the art for current-generation drug-eluting stents. Choosing between them would be very difficult. They seemed to be fairly equivalent for most of the important safety and efficacy metrics. They are both superb," said Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy at Columbia University in New York, and lead investigator for the RESOLUTE US study.

But other interventionalists hearing the data from both studies weren’t as completely convinced.

"My initial take on the data is that [the ZES] doesn’t seem to be better than the Xience stent, which is a very good stent and the dominant stent we use [in the United States] at this time," commented Dr. Abhiram Prasad, an interventional cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn. "Solely on the basis of these data, I don’t think I would foresee a major shift in our use of the Xience stent," he said in an interview.

Safety concerns with the ZES date back to the initial, 12-month follow-up report, the first indication that the ZES fell short, compared with the EES on the rate of stent thrombosis in the RESOLUTE All Comers trial. The New England Journal of Medicine report last year documented 18 patients (1.6%) with definite or probable stent thrombosis in the ZES arm, compared with 8 cases (0.7%) of definite or probable stent thrombosis in the EES group, a significant difference (N. Engl. J. Med. 2010;363:136-46).

The new, 24-month follow-up data provided some reassurance on safety, in that the stent thrombosis gap between the two stents stayed stable. During an extra year of follow-up, three new cases of definite or probable stent thrombosis occurred in each of the two treatment arms, said Dr. Patrick W. Serruys, professor of interventional cardiology at Erasmus University and the Thoraxcentrum, Rotterdam, and lead investigator for the RESOLUTE All Comers trial. Aside from this one early safety deviation, the ZES and EES continued to show virtually identical efficacy performance through the 2 years of study, he showed in the updated data. Concurrently with his report at the meeting, the results appeared in an article published in the Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

Dr. Serruys, as well as others, chalked up the early difference in stent thrombosis rates to chance, and to some isolated poor performance in certain sites undertaking the coronary interventions.

"Numerically, the stent thrombosis is very small, a difference of 21 versus 11 patients in more than 2,000 total patients. It could be the play of chance," Dr. Serruys said.

The RESOLUTE US results seemed to add to the safety assurance. In those 1,402 patients, 2 cases (0.1%) of stent thrombosis occurred during 12 months of tracking. Concurrently with Dr. Leon’s report, the RESOLUTE US results appeared in an article in the Journal of the American College of Cardiology (J. Amer. Coll. Cardiol. 2011 April 4 [doi:10.1016/j.jacc.2011.03.005]).

"This is one of the lowest 1-year stent thrombosis rates ever reported," noted Dr. Leon. "I take from this that it’s a safe stent. There was anxiety when RESOLUTE All Comers suggested a higher than expected stent thrombosis rate compared with Xience. The [RESOLUTE US] data help us realize that we need data density to get our hands around stent thrombosis. I’m not sure that 0.1% is the correct number either. By chance you’ll see study variations."

The pattern of some of the earliest cases of stent thrombosis in RESOLUTE All Comers suggested that it may have been caused more by operator failings and less by problems with the stent itself. During the study’s first 30 days, stent thrombosis occurred in nine ZES patients and one EES patient, making up most of the differential that wound up haunting the ZES arm through the next 2 years. "Stent thrombosis during the first 30 days is procedure related," and generally the stent itself plays no role, said Dr. Alan C. Yeung, professor of medicine and director of cardiac catheterization at Stanford (Calif.) University in Palo Alto.

"Whether it’s a real difference or a play of chance remains undetermined," commented Dr. Mitchell W. Krucoff, a professor of medicine and interventional cardiologist at Duke University in Durham, N.C. "These types of differences [21 patients versus 11 patients] are not certain at a statistical level." He called the question of a safety difference between the two stents "an open question," adding that "all the rest is superimposable" between the ZES and EES.

So if the ZES hopes to wrest any market share from the EES when it hits the U.S. market, it may need to have something to distinguish it, and that something may be an FDA-approved indication for treatment of coronary stenoses in patients with diabetes. At least that’s what Medtronic is hoping for. The company included that application in its submission to the FDA, Jason Fontana, Ph.D., senior director for clinical communication at Medtronic, said in an interview. If the ZES gets this indication, it will make the device unique. No other coronary stent now on the U.S. market carries that indication in its label.

"The diabetes subgroup was large enough, and the diabetes analysis was prespecified" in RESOLUTE US, Dr. Leon said in an interview. "If you include this subgroup, and the RESOLUTE All Comers diabetes subgroup, you have a robust enough population to justify consideration for approval, I think," he said.

"The results were quite substantial," with a 3.0% rate of target-lesion revascularization among the patients with diabetes, compared with a 2.0% rate for the entire main cohort of the study. "Usually you see more of a bump in patients with diabetes," he said. "To see a 3% repeat revascularization rate in patients with diabetes is very encouraging. I think if the stent gets this indication it may have an impact. It’s an important consideration."

But even if the diabetes indication works out, will interventionalists be swayed by that, or by the data?

"An issue is, to what extent can a single trial address a subgroup?" said Dr. Krucoff. "To what degree is there statistical guidance that in the real world [the ZES] would live up to this measure?"

"I don’t think I’d put a lot of emphasis of my decision-making on the [RESOLUTE US] data, because a problem with all [stenting] studies is that the rates are constantly improving, so the new device can appear to be better," said Dr. Prasad. "The study did not use a SYNTAX score to give us an idea of how complex the patients were. Unless we know about the complexity of the disease in the diabetes patients, I’m not sure we can call it a superior performance than what one would expect in today’s practice. Even if [the ZES] was approved for use in patients with diabetes, I don’t think in my practice I’d pick it to use in those patients. They’d need to do a randomized study in patients with diabetes to convince me" that it was better than the EES, Dr. Prasad said.

Dr. Serruys said he had no disclosures. Dr. Prasad said he had no disclosures. Dr. Leon said that he serves as an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Yeung said that he serves on the scientific advisory board of Medtronic; he is also a consultant for Abbott Vascular, Boston Scientific, and Cordis, and has received research grants from Boston Scientific, Edwards, and Medtronic. Dr. Fontana is an employee of Medtronic. Dr. Krucoff said that he has been a consultant to or has received honoraria from Abbott, Biosensors, Cardiomind, Cordis Johnson & Johnson, Medtronic, Merck, Micelle, OrbusNeich, Prescient, Sanofi-Aventis, and Terumo.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.