ACC 2011

NEW ORLEANS – Calcium channel blockers and diuretics are the best drugs for treating hypertension in the elderly because they are the most effective at reducing the risk of what elderly patients fear most: stroke, Dr. Norman M. Kaplan asserted at the annual meeting of the American College of Cardiology.

"Coronary disease remains by far the most common cause of mortality [in the United States], but stroke poses the greatest threat to the elderly, not coronary disease," said Dr. Kaplan, professor of internal medicine at the University of Texas, Dallas.

He presented a state-of-the-art perspective on antihypertensive therapy in the elderly from the unique vantage point of having served as a member of the third, fourth, fifth, and sixth Joint National Committees on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.

Dr. Kaplan noted that a British meta-analysis of 46 randomized trials comparing each of the five major classes of antihypertensive drugs with any other class showed that all of the classes were similarly effective in preventing both coronary disease events and strokes, with one exception: calcium channel blockers had a significantly greater preventive effect on stroke than other agents. Diuretics showed a trend in the same direction that didn’t reach statistical significance (BMJ 2009;338:b1665 [doi:10.1136/BMJ.b1665]).

More recently, a secondary analysis of the 19,257-subject ASCOT (Anglo-Scandinavian Cardiac Outcomes Trial) demonstrated that calcium channel blocker–based antihypertensive therapy was particularly effective against stroke in the population most in need of such protection: the elderly. Although there was no significant difference in strokes between amlodipine- and atenolol-based therapy in patients younger than age 65 years, there was a highly significant 30% relative risk reduction with amlodipine in the over-65 group (J. Hypertens. 2011;29:583-91).

The latest thinking regarding mechanism of benefit is that calcium channel blockers and diuretics are more effective at reducing stroke risk because they decrease within-individual variation in systolic blood pressure, unlike angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and beta-blockers, all of which significantly increase it. In a meta-analysis of 389 randomized, controlled trials of antihypertensive therapy, stroke risk proved strongly related to this interindividual variation in blood pressure (Lancet 2010;375:906-15).

In addition to reducing stroke risk, calcium channel blockers may also have a neuroprotective effect. A French study of 378 elderly, nondemented, hypertensive patients with the complaint of memory loss showed that memory scores were significantly better in those on a calcium channel blocker than on any other class of antihypertensive medication (J. Hypertens. 2010;28:2485-93). Although that’s an intriguing finding, this was an observational study and needs confirmation, in Dr. Kaplan’s view.

Elderly hypertensives predominantly have isolated systolic hypertension. Because of the extensive body of evidence showing that such patients have a good response rate to diuretic monotherapy, he recommends using a diuretic as the first-line drug.

"I would start chlorthalidone – now having a resurgence as the diuretic of choice – at 12.5 mg/day, and add a calcium channel blocker if additional therapy is needed to reach 150/70 mm Hg, which I think is a rational goal to aim for in the elderly," he said.

Indeed, although the 7th Joint National Committee calls 140 mm Hg the upper limit of normal systolic blood pressure at all ages, nearly all the randomized trials that have shown a protective value for antihypertensive therapy in the elderly enrolled patients with a baseline systolic pressure in excess of 160 mm Hg, and achieved an on-treatment systolic pressure in the 150s or 160s.

"I do not think the evidence we have to date shows protective value for treatment in patients with a baseline systolic blood pressure below 160 mm Hg. There is evidence to suggest that if we lower the elderly patient’s systolic blood pressure more than 10-15 mm Hg, we may be invoking additional trouble rather than protecting the patient," said Dr. Kaplan.

"These are old people who obviously have atherosclerotic vascular disease, even if they don’t show it. Reduction in diastolic blood pressure to 65 mm Hg or lower may reduce their coronary perfusion – which occurs only during diastole – to a degree that could invoke a cardiovascular catastrophe," he continued.

Other important aspects of treating elderly hypertensive patients include identifying and overcoming postural hypotension, encouraging the consumption of one or two alcoholic drinks per day for the well-documented health benefits, starting a statin, and measuring home blood pressures to ensure that an individual really is being treated adequately, Dr. Kaplan said.

The risks posed by orthostatic hypotension were recently highlighted in a study of 374 unselected ambulatory adults with an average age of 70 years and no known cardiovascular disease or other comorbidities. An orthostatic decrease in systolic blood pressure greater than 20 mm Hg was present 2 minutes after standing in 12% of them. Over roughly 1 year of follow-up, cardiovascular events were 2.4-fold more frequent in that patient subset (Hypertension 2010;56:56-61).

There are no safe and effective medications for the treatment of orthostatic hypotension. Fortunately, this condition generally responds to nondrug measures, including avoidance of fluid-volume depletion, taking up to 2 full minutes to rise from supine to standing in the morning, raising the head of the bed 15 degrees to help maintain a degree of sympathetic nervous system activation during the night, eating a small breakfast, and crossing the legs when feeling unsteady while standing.

Dr. Kaplan disclosed that he is on the speakers bureaus for Pfizer, AstraZeneca, Merck, Novartis, and Bayer.

NEW ORLEANS – Calcium channel blockers and diuretics are the best drugs for treating hypertension in the elderly because they are the most effective at reducing the risk of what elderly patients fear most: stroke, Dr. Norman M. Kaplan asserted at the annual meeting of the American College of Cardiology.

"Coronary disease remains by far the most common cause of mortality [in the United States], but stroke poses the greatest threat to the elderly, not coronary disease," said Dr. Kaplan, professor of internal medicine at the University of Texas, Dallas.

He presented a state-of-the-art perspective on antihypertensive therapy in the elderly from the unique vantage point of having served as a member of the third, fourth, fifth, and sixth Joint National Committees on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.

Dr. Kaplan noted that a British meta-analysis of 46 randomized trials comparing each of the five major classes of antihypertensive drugs with any other class showed that all of the classes were similarly effective in preventing both coronary disease events and strokes, with one exception: calcium channel blockers had a significantly greater preventive effect on stroke than other agents. Diuretics showed a trend in the same direction that didn’t reach statistical significance (BMJ 2009;338:b1665 [doi:10.1136/BMJ.b1665]).

More recently, a secondary analysis of the 19,257-subject ASCOT (Anglo-Scandinavian Cardiac Outcomes Trial) demonstrated that calcium channel blocker–based antihypertensive therapy was particularly effective against stroke in the population most in need of such protection: the elderly. Although there was no significant difference in strokes between amlodipine- and atenolol-based therapy in patients younger than age 65 years, there was a highly significant 30% relative risk reduction with amlodipine in the over-65 group (J. Hypertens. 2011;29:583-91).

The latest thinking regarding mechanism of benefit is that calcium channel blockers and diuretics are more effective at reducing stroke risk because they decrease within-individual variation in systolic blood pressure, unlike angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and beta-blockers, all of which significantly increase it. In a meta-analysis of 389 randomized, controlled trials of antihypertensive therapy, stroke risk proved strongly related to this interindividual variation in blood pressure (Lancet 2010;375:906-15).

In addition to reducing stroke risk, calcium channel blockers may also have a neuroprotective effect. A French study of 378 elderly, nondemented, hypertensive patients with the complaint of memory loss showed that memory scores were significantly better in those on a calcium channel blocker than on any other class of antihypertensive medication (J. Hypertens. 2010;28:2485-93). Although that’s an intriguing finding, this was an observational study and needs confirmation, in Dr. Kaplan’s view.

Elderly hypertensives predominantly have isolated systolic hypertension. Because of the extensive body of evidence showing that such patients have a good response rate to diuretic monotherapy, he recommends using a diuretic as the first-line drug.

"I would start chlorthalidone – now having a resurgence as the diuretic of choice – at 12.5 mg/day, and add a calcium channel blocker if additional therapy is needed to reach 150/70 mm Hg, which I think is a rational goal to aim for in the elderly," he said.

Indeed, although the 7th Joint National Committee calls 140 mm Hg the upper limit of normal systolic blood pressure at all ages, nearly all the randomized trials that have shown a protective value for antihypertensive therapy in the elderly enrolled patients with a baseline systolic pressure in excess of 160 mm Hg, and achieved an on-treatment systolic pressure in the 150s or 160s.

"I do not think the evidence we have to date shows protective value for treatment in patients with a baseline systolic blood pressure below 160 mm Hg. There is evidence to suggest that if we lower the elderly patient’s systolic blood pressure more than 10-15 mm Hg, we may be invoking additional trouble rather than protecting the patient," said Dr. Kaplan.

"These are old people who obviously have atherosclerotic vascular disease, even if they don’t show it. Reduction in diastolic blood pressure to 65 mm Hg or lower may reduce their coronary perfusion – which occurs only during diastole – to a degree that could invoke a cardiovascular catastrophe," he continued.

Other important aspects of treating elderly hypertensive patients include identifying and overcoming postural hypotension, encouraging the consumption of one or two alcoholic drinks per day for the well-documented health benefits, starting a statin, and measuring home blood pressures to ensure that an individual really is being treated adequately, Dr. Kaplan said.

The risks posed by orthostatic hypotension were recently highlighted in a study of 374 unselected ambulatory adults with an average age of 70 years and no known cardiovascular disease or other comorbidities. An orthostatic decrease in systolic blood pressure greater than 20 mm Hg was present 2 minutes after standing in 12% of them. Over roughly 1 year of follow-up, cardiovascular events were 2.4-fold more frequent in that patient subset (Hypertension 2010;56:56-61).

There are no safe and effective medications for the treatment of orthostatic hypotension. Fortunately, this condition generally responds to nondrug measures, including avoidance of fluid-volume depletion, taking up to 2 full minutes to rise from supine to standing in the morning, raising the head of the bed 15 degrees to help maintain a degree of sympathetic nervous system activation during the night, eating a small breakfast, and crossing the legs when feeling unsteady while standing.

Dr. Kaplan disclosed that he is on the speakers bureaus for Pfizer, AstraZeneca, Merck, Novartis, and Bayer.

NEW ORLEANS – Calcium channel blockers and diuretics are the best drugs for treating hypertension in the elderly because they are the most effective at reducing the risk of what elderly patients fear most: stroke, Dr. Norman M. Kaplan asserted at the annual meeting of the American College of Cardiology.

"Coronary disease remains by far the most common cause of mortality [in the United States], but stroke poses the greatest threat to the elderly, not coronary disease," said Dr. Kaplan, professor of internal medicine at the University of Texas, Dallas.

He presented a state-of-the-art perspective on antihypertensive therapy in the elderly from the unique vantage point of having served as a member of the third, fourth, fifth, and sixth Joint National Committees on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.

Dr. Kaplan noted that a British meta-analysis of 46 randomized trials comparing each of the five major classes of antihypertensive drugs with any other class showed that all of the classes were similarly effective in preventing both coronary disease events and strokes, with one exception: calcium channel blockers had a significantly greater preventive effect on stroke than other agents. Diuretics showed a trend in the same direction that didn’t reach statistical significance (BMJ 2009;338:b1665 [doi:10.1136/BMJ.b1665]).

More recently, a secondary analysis of the 19,257-subject ASCOT (Anglo-Scandinavian Cardiac Outcomes Trial) demonstrated that calcium channel blocker–based antihypertensive therapy was particularly effective against stroke in the population most in need of such protection: the elderly. Although there was no significant difference in strokes between amlodipine- and atenolol-based therapy in patients younger than age 65 years, there was a highly significant 30% relative risk reduction with amlodipine in the over-65 group (J. Hypertens. 2011;29:583-91).

The latest thinking regarding mechanism of benefit is that calcium channel blockers and diuretics are more effective at reducing stroke risk because they decrease within-individual variation in systolic blood pressure, unlike angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and beta-blockers, all of which significantly increase it. In a meta-analysis of 389 randomized, controlled trials of antihypertensive therapy, stroke risk proved strongly related to this interindividual variation in blood pressure (Lancet 2010;375:906-15).

In addition to reducing stroke risk, calcium channel blockers may also have a neuroprotective effect. A French study of 378 elderly, nondemented, hypertensive patients with the complaint of memory loss showed that memory scores were significantly better in those on a calcium channel blocker than on any other class of antihypertensive medication (J. Hypertens. 2010;28:2485-93). Although that’s an intriguing finding, this was an observational study and needs confirmation, in Dr. Kaplan’s view.

Elderly hypertensives predominantly have isolated systolic hypertension. Because of the extensive body of evidence showing that such patients have a good response rate to diuretic monotherapy, he recommends using a diuretic as the first-line drug.

"I would start chlorthalidone – now having a resurgence as the diuretic of choice – at 12.5 mg/day, and add a calcium channel blocker if additional therapy is needed to reach 150/70 mm Hg, which I think is a rational goal to aim for in the elderly," he said.

Indeed, although the 7th Joint National Committee calls 140 mm Hg the upper limit of normal systolic blood pressure at all ages, nearly all the randomized trials that have shown a protective value for antihypertensive therapy in the elderly enrolled patients with a baseline systolic pressure in excess of 160 mm Hg, and achieved an on-treatment systolic pressure in the 150s or 160s.

"I do not think the evidence we have to date shows protective value for treatment in patients with a baseline systolic blood pressure below 160 mm Hg. There is evidence to suggest that if we lower the elderly patient’s systolic blood pressure more than 10-15 mm Hg, we may be invoking additional trouble rather than protecting the patient," said Dr. Kaplan.

"These are old people who obviously have atherosclerotic vascular disease, even if they don’t show it. Reduction in diastolic blood pressure to 65 mm Hg or lower may reduce their coronary perfusion – which occurs only during diastole – to a degree that could invoke a cardiovascular catastrophe," he continued.

Other important aspects of treating elderly hypertensive patients include identifying and overcoming postural hypotension, encouraging the consumption of one or two alcoholic drinks per day for the well-documented health benefits, starting a statin, and measuring home blood pressures to ensure that an individual really is being treated adequately, Dr. Kaplan said.

The risks posed by orthostatic hypotension were recently highlighted in a study of 374 unselected ambulatory adults with an average age of 70 years and no known cardiovascular disease or other comorbidities. An orthostatic decrease in systolic blood pressure greater than 20 mm Hg was present 2 minutes after standing in 12% of them. Over roughly 1 year of follow-up, cardiovascular events were 2.4-fold more frequent in that patient subset (Hypertension 2010;56:56-61).

There are no safe and effective medications for the treatment of orthostatic hypotension. Fortunately, this condition generally responds to nondrug measures, including avoidance of fluid-volume depletion, taking up to 2 full minutes to rise from supine to standing in the morning, raising the head of the bed 15 degrees to help maintain a degree of sympathetic nervous system activation during the night, eating a small breakfast, and crossing the legs when feeling unsteady while standing.

Dr. Kaplan disclosed that he is on the speakers bureaus for Pfizer, AstraZeneca, Merck, Novartis, and Bayer.

NEW ORLEANS – In major clinical trials of lipid-lowering agents, the mortality benefit derived from medical therapy persists long after the studies end, according to a meta-analysis presented at the annual meeting of the American College of Cardiology.

Furthermore, placebo recipients who cross over to lipid-lowering therapy in the open-label phases of the studies demonstrate survival benefits as well, but never attain the protection achieved by being randomized to active treatment earlier on, according to Dr. William J. Kostis of Massachusetts General Hospital, Boston. "Persons with risk factors for coronary artery disease should be treated early," Dr. Kostis said in an interview. "The sooner you treat, the better."

He and his colleagues searched several major databases to identify randomized trials of lipid-lowering therapies that also contained an analysis of patient outcomes after the randomized portion of the trials had ended and an open-label phase had begun. Active treatment in the trials involved statins, niacin, cholestyramine, or gemfibrozil.

The analysis included eight clinical trials involving 44,255 patients, of whom 8,144 died during follow-up.

The average patient remained on the assigned treatment for approximately 5 years and was on the lipid-lowering agent in the open-label phase for approximately 6 years.

During the randomized phase of the trials, the mean all-cause mortality was significantly lower for the active treatment group (odds ratio, 0.84; P = .0006), as was cardiovascular mortality (0.72; P less than .001). The lower mortality among those initially receiving active therapy persisted during the open-label follow-up phase (OR, 0.90; P = .0035), as did the reduction in cardiovascular mortality (OR, 0.82; P = .0014).

"Being treated with a beneficial medication for a longer period of time is better, possibly because we are arresting pathophysiology at an earlier stage," Dr. Kostis proposed. He added that statins may be reducing the size of infarcts in patients who have myocardial infarctions.

Dr. Patrick Moriarty, a lipid specialist and a professor of medicine at the University of Kansas in Kansas City, agreed. "We need to start lipid-lowering therapy early to get the most benefit," and this includes interventions in children when necessary, he added.

"We treat pediatric patients all the time," he said, "not only those with familial hyperlipidemias but also those with metabolic syndrome. ... The future emphasis will be, ‘the sooner the better.’ "

Dr. Kostis and Dr. Moriarty reported having no relevant conflicts of interest.

NEW ORLEANS – In major clinical trials of lipid-lowering agents, the mortality benefit derived from medical therapy persists long after the studies end, according to a meta-analysis presented at the annual meeting of the American College of Cardiology.

Furthermore, placebo recipients who cross over to lipid-lowering therapy in the open-label phases of the studies demonstrate survival benefits as well, but never attain the protection achieved by being randomized to active treatment earlier on, according to Dr. William J. Kostis of Massachusetts General Hospital, Boston. "Persons with risk factors for coronary artery disease should be treated early," Dr. Kostis said in an interview. "The sooner you treat, the better."

He and his colleagues searched several major databases to identify randomized trials of lipid-lowering therapies that also contained an analysis of patient outcomes after the randomized portion of the trials had ended and an open-label phase had begun. Active treatment in the trials involved statins, niacin, cholestyramine, or gemfibrozil.

The analysis included eight clinical trials involving 44,255 patients, of whom 8,144 died during follow-up.

The average patient remained on the assigned treatment for approximately 5 years and was on the lipid-lowering agent in the open-label phase for approximately 6 years.

During the randomized phase of the trials, the mean all-cause mortality was significantly lower for the active treatment group (odds ratio, 0.84; P = .0006), as was cardiovascular mortality (0.72; P less than .001). The lower mortality among those initially receiving active therapy persisted during the open-label follow-up phase (OR, 0.90; P = .0035), as did the reduction in cardiovascular mortality (OR, 0.82; P = .0014).

"Being treated with a beneficial medication for a longer period of time is better, possibly because we are arresting pathophysiology at an earlier stage," Dr. Kostis proposed. He added that statins may be reducing the size of infarcts in patients who have myocardial infarctions.

Dr. Patrick Moriarty, a lipid specialist and a professor of medicine at the University of Kansas in Kansas City, agreed. "We need to start lipid-lowering therapy early to get the most benefit," and this includes interventions in children when necessary, he added.

"We treat pediatric patients all the time," he said, "not only those with familial hyperlipidemias but also those with metabolic syndrome. ... The future emphasis will be, ‘the sooner the better.’ "

Dr. Kostis and Dr. Moriarty reported having no relevant conflicts of interest.

NEW ORLEANS – In major clinical trials of lipid-lowering agents, the mortality benefit derived from medical therapy persists long after the studies end, according to a meta-analysis presented at the annual meeting of the American College of Cardiology.

Furthermore, placebo recipients who cross over to lipid-lowering therapy in the open-label phases of the studies demonstrate survival benefits as well, but never attain the protection achieved by being randomized to active treatment earlier on, according to Dr. William J. Kostis of Massachusetts General Hospital, Boston. "Persons with risk factors for coronary artery disease should be treated early," Dr. Kostis said in an interview. "The sooner you treat, the better."

He and his colleagues searched several major databases to identify randomized trials of lipid-lowering therapies that also contained an analysis of patient outcomes after the randomized portion of the trials had ended and an open-label phase had begun. Active treatment in the trials involved statins, niacin, cholestyramine, or gemfibrozil.

The analysis included eight clinical trials involving 44,255 patients, of whom 8,144 died during follow-up.

The average patient remained on the assigned treatment for approximately 5 years and was on the lipid-lowering agent in the open-label phase for approximately 6 years.

During the randomized phase of the trials, the mean all-cause mortality was significantly lower for the active treatment group (odds ratio, 0.84; P = .0006), as was cardiovascular mortality (0.72; P less than .001). The lower mortality among those initially receiving active therapy persisted during the open-label follow-up phase (OR, 0.90; P = .0035), as did the reduction in cardiovascular mortality (OR, 0.82; P = .0014).

"Being treated with a beneficial medication for a longer period of time is better, possibly because we are arresting pathophysiology at an earlier stage," Dr. Kostis proposed. He added that statins may be reducing the size of infarcts in patients who have myocardial infarctions.

Dr. Patrick Moriarty, a lipid specialist and a professor of medicine at the University of Kansas in Kansas City, agreed. "We need to start lipid-lowering therapy early to get the most benefit," and this includes interventions in children when necessary, he added.

"We treat pediatric patients all the time," he said, "not only those with familial hyperlipidemias but also those with metabolic syndrome. ... The future emphasis will be, ‘the sooner the better.’ "

Dr. Kostis and Dr. Moriarty reported having no relevant conflicts of interest.

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. 

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 – Short and standard durations of dual-antiplatelet therapy were equally protective against target vessel failure in drug-eluting stent recipients, Korean researchers reported at the annual meeting of the American College of Cardiology.

With the exception of patients who had diabetes, the overall 12-month clinical event rates were not different between 6-month and 12-month treatment duration groups for all-cause mortality, cardiac death, myocardial infarction, cerebrovascular accident, target vessel revascularization, stent thrombosis, major bleeding, or various composites of the above end points, reported Dr. Hyeon-Cheol Gwon of Samsung Medical Center at Sungkyunkwan University in Seoul.

"At least in low-risk patients getting drug-eluting stents, that is, nondiabetics, maybe we can safely discontinue clopidogrel at 6 months," he said. Current guidelines recommend at least 12 months of anticoagulation to prevent venous thromboembolism.

Early discontinuation of antiplatelet therapy might be particularly relevant for patients at high risk of bleeding or those anticipating subsequent procedures, which are often delayed while the drugs are withdrawn.

But Dr. Sanjay Kaul of Cedars-Sinai Medical Center, Los Angeles, an invited panelist at the late-breaking clinical trials session where the results were presented, questioned the researchers’ use of target vessel failure (TVF) as the primary study end point. TVF was defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization.

Dr. Gwon acknowledged that "the study was underpowered to test the hard end points that we are really interested in. ... We recognize our study is hypothesis generating."

The trial involved 1,443 patients with greater than 50% stenosis and evidence of myocardial ischemia. Patients receiving everolimus- or sirolimus-eluting stents were randomized to receive 6 or 12 months of dual antiplatelet therapy with clopidogrel and aspirin.

The study found that discontinuing clopidogrel and aspirin after 6 months did not increase the rate of 12-month TVF. The rates were 4.7% for the 6-month group and 4.4% for the 12-month group. By Kaplan-Meier analysis, the cumulative proportional TVF estimate at 1 year was 5.2% for the 6-month regimen and 4.3% for the 12-month regimen, which met the noninferiority end point "in a highly significant manner with a confidence interval that was smaller than prespecified for noninferiority" (P = .0031; upper 1-sided 97.5% CI 0.9%-3.6%), Dr. Gwon said.

The cumulative incidence of major adverse cardiac or coronary events was 7.5% with 6-month therapy and 8.4% with 12-month therapy.

There was also no significant difference according to whether patients received an everolimus- or sirolimus-eluting stent, though the rates were numerically closer in the everolimus group.

There was, however, a significantly higher risk for primary TVF with early discontinuation of antiplatelet therapy for patients with diabetes. Diabetic patients receiving 6 months of dual antiplatelet therapy had a TVF rate of 8.9%, vs. 2.9% with 12 months of treatment (P = .006).

There were no other significant subgroup differences.

Crossovers were common, primarily in that patients on the 6-month regimen received clopidogrel for a longer duration than assigned. Non-inferiority between the arms was maintained in a per-protocol analysis of 936 patients that excluded patients who crossed over, were lost to follow-up or otherwise did not receive treatment as assigned.

The per-protocol analysis showed the cumulative proportional TVF estimates at 1 year to be 3.6% in the 6-month group and 4.3% in the 12-month group (P = .0093 for noninferiority). TVF incidence rates were 3.2% and 2.1%, respectively, Dr. Gwon reported.

Dr. Byron Lee of the University of California in San Francisco, noted at a press briefing, "Frequently, we are confronted by patients on clopidogrel and aspirin, and we may have to put a pacemaker or defibrillator in them. Knowing that this study showed noninferiority, I feel much more comfortable now taking them off clopidogrel if it’s been past 6 months."

Dr. Gwon reported consulting fees and honoraria from Cordis and Medtronic as well as research support from Abbott Korea and Medtronic Korea. Dr. Lee reported consulting fees and honoraria from Biotronik, St. Jude, and Nanostim, as well as research funding from Medtronic and Zoll. Dr. Kaul serves on the Food and Drug Administration’s Cardiorenal Advisory Panel and has received consulting fees and honoraria from Novo Nordisk and Hoffman-LaRoche.

NEW ORLEANS – Short and standard durations of dual-antiplatelet therapy were equally protective against target vessel failure in drug-eluting stent recipients, Korean researchers reported at the annual meeting of the American College of Cardiology.

With the exception of patients who had diabetes, the overall 12-month clinical event rates were not different between 6-month and 12-month treatment duration groups for all-cause mortality, cardiac death, myocardial infarction, cerebrovascular accident, target vessel revascularization, stent thrombosis, major bleeding, or various composites of the above end points, reported Dr. Hyeon-Cheol Gwon of Samsung Medical Center at Sungkyunkwan University in Seoul.

"At least in low-risk patients getting drug-eluting stents, that is, nondiabetics, maybe we can safely discontinue clopidogrel at 6 months," he said. Current guidelines recommend at least 12 months of anticoagulation to prevent venous thromboembolism.

Early discontinuation of antiplatelet therapy might be particularly relevant for patients at high risk of bleeding or those anticipating subsequent procedures, which are often delayed while the drugs are withdrawn.

But Dr. Sanjay Kaul of Cedars-Sinai Medical Center, Los Angeles, an invited panelist at the late-breaking clinical trials session where the results were presented, questioned the researchers’ use of target vessel failure (TVF) as the primary study end point. TVF was defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization.

Dr. Gwon acknowledged that "the study was underpowered to test the hard end points that we are really interested in. ... We recognize our study is hypothesis generating."

The trial involved 1,443 patients with greater than 50% stenosis and evidence of myocardial ischemia. Patients receiving everolimus- or sirolimus-eluting stents were randomized to receive 6 or 12 months of dual antiplatelet therapy with clopidogrel and aspirin.

The study found that discontinuing clopidogrel and aspirin after 6 months did not increase the rate of 12-month TVF. The rates were 4.7% for the 6-month group and 4.4% for the 12-month group. By Kaplan-Meier analysis, the cumulative proportional TVF estimate at 1 year was 5.2% for the 6-month regimen and 4.3% for the 12-month regimen, which met the noninferiority end point "in a highly significant manner with a confidence interval that was smaller than prespecified for noninferiority" (P = .0031; upper 1-sided 97.5% CI 0.9%-3.6%), Dr. Gwon said.

The cumulative incidence of major adverse cardiac or coronary events was 7.5% with 6-month therapy and 8.4% with 12-month therapy.

There was also no significant difference according to whether patients received an everolimus- or sirolimus-eluting stent, though the rates were numerically closer in the everolimus group.

There was, however, a significantly higher risk for primary TVF with early discontinuation of antiplatelet therapy for patients with diabetes. Diabetic patients receiving 6 months of dual antiplatelet therapy had a TVF rate of 8.9%, vs. 2.9% with 12 months of treatment (P = .006).

There were no other significant subgroup differences.

Crossovers were common, primarily in that patients on the 6-month regimen received clopidogrel for a longer duration than assigned. Non-inferiority between the arms was maintained in a per-protocol analysis of 936 patients that excluded patients who crossed over, were lost to follow-up or otherwise did not receive treatment as assigned.

The per-protocol analysis showed the cumulative proportional TVF estimates at 1 year to be 3.6% in the 6-month group and 4.3% in the 12-month group (P = .0093 for noninferiority). TVF incidence rates were 3.2% and 2.1%, respectively, Dr. Gwon reported.

Dr. Byron Lee of the University of California in San Francisco, noted at a press briefing, "Frequently, we are confronted by patients on clopidogrel and aspirin, and we may have to put a pacemaker or defibrillator in them. Knowing that this study showed noninferiority, I feel much more comfortable now taking them off clopidogrel if it’s been past 6 months."

Dr. Gwon reported consulting fees and honoraria from Cordis and Medtronic as well as research support from Abbott Korea and Medtronic Korea. Dr. Lee reported consulting fees and honoraria from Biotronik, St. Jude, and Nanostim, as well as research funding from Medtronic and Zoll. Dr. Kaul serves on the Food and Drug Administration’s Cardiorenal Advisory Panel and has received consulting fees and honoraria from Novo Nordisk and Hoffman-LaRoche.

NEW ORLEANS – Short and standard durations of dual-antiplatelet therapy were equally protective against target vessel failure in drug-eluting stent recipients, Korean researchers reported at the annual meeting of the American College of Cardiology.

With the exception of patients who had diabetes, the overall 12-month clinical event rates were not different between 6-month and 12-month treatment duration groups for all-cause mortality, cardiac death, myocardial infarction, cerebrovascular accident, target vessel revascularization, stent thrombosis, major bleeding, or various composites of the above end points, reported Dr. Hyeon-Cheol Gwon of Samsung Medical Center at Sungkyunkwan University in Seoul.

"At least in low-risk patients getting drug-eluting stents, that is, nondiabetics, maybe we can safely discontinue clopidogrel at 6 months," he said. Current guidelines recommend at least 12 months of anticoagulation to prevent venous thromboembolism.

Early discontinuation of antiplatelet therapy might be particularly relevant for patients at high risk of bleeding or those anticipating subsequent procedures, which are often delayed while the drugs are withdrawn.

But Dr. Sanjay Kaul of Cedars-Sinai Medical Center, Los Angeles, an invited panelist at the late-breaking clinical trials session where the results were presented, questioned the researchers’ use of target vessel failure (TVF) as the primary study end point. TVF was defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization.

Dr. Gwon acknowledged that "the study was underpowered to test the hard end points that we are really interested in. ... We recognize our study is hypothesis generating."

The trial involved 1,443 patients with greater than 50% stenosis and evidence of myocardial ischemia. Patients receiving everolimus- or sirolimus-eluting stents were randomized to receive 6 or 12 months of dual antiplatelet therapy with clopidogrel and aspirin.

The study found that discontinuing clopidogrel and aspirin after 6 months did not increase the rate of 12-month TVF. The rates were 4.7% for the 6-month group and 4.4% for the 12-month group. By Kaplan-Meier analysis, the cumulative proportional TVF estimate at 1 year was 5.2% for the 6-month regimen and 4.3% for the 12-month regimen, which met the noninferiority end point "in a highly significant manner with a confidence interval that was smaller than prespecified for noninferiority" (P = .0031; upper 1-sided 97.5% CI 0.9%-3.6%), Dr. Gwon said.

The cumulative incidence of major adverse cardiac or coronary events was 7.5% with 6-month therapy and 8.4% with 12-month therapy.

There was also no significant difference according to whether patients received an everolimus- or sirolimus-eluting stent, though the rates were numerically closer in the everolimus group.

There was, however, a significantly higher risk for primary TVF with early discontinuation of antiplatelet therapy for patients with diabetes. Diabetic patients receiving 6 months of dual antiplatelet therapy had a TVF rate of 8.9%, vs. 2.9% with 12 months of treatment (P = .006).

There were no other significant subgroup differences.

Crossovers were common, primarily in that patients on the 6-month regimen received clopidogrel for a longer duration than assigned. Non-inferiority between the arms was maintained in a per-protocol analysis of 936 patients that excluded patients who crossed over, were lost to follow-up or otherwise did not receive treatment as assigned.

The per-protocol analysis showed the cumulative proportional TVF estimates at 1 year to be 3.6% in the 6-month group and 4.3% in the 12-month group (P = .0093 for noninferiority). TVF incidence rates were 3.2% and 2.1%, respectively, Dr. Gwon reported.

Dr. Byron Lee of the University of California in San Francisco, noted at a press briefing, "Frequently, we are confronted by patients on clopidogrel and aspirin, and we may have to put a pacemaker or defibrillator in them. Knowing that this study showed noninferiority, I feel much more comfortable now taking them off clopidogrel if it’s been past 6 months."

Dr. Gwon reported consulting fees and honoraria from Cordis and Medtronic as well as research support from Abbott Korea and Medtronic Korea. Dr. Lee reported consulting fees and honoraria from Biotronik, St. Jude, and Nanostim, as well as research funding from Medtronic and Zoll. Dr. Kaul serves on the Food and Drug Administration’s Cardiorenal Advisory Panel and has received consulting fees and honoraria from Novo Nordisk and Hoffman-LaRoche.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania 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.