ESC Congress 2011

PARIS – Coronary artery bypass grafting surpassed percutaneous coronary intervention in a "real-world," registry of patients with three-vessel coronary disease, largely confirming the findings of the SYNTAX trial in patients with high SYNTAX scores and in those with low scores.

However, because the new data – obtained at 26 Japanese centers during 2005-2007 and involving nearly 3,000 patients – came from a nonrandomized registry, it may have been flawed by selection biases that skewed which patients underwent bypass surgery and which ones had percutaneous revascularization.

Coronary artery bypass grafting (CABG) "remains the standard treatment option for patients with triple-vessel disease, even when their SYNTAX scores are high," Dr. Hiroki Shiomi said at the annual congress of the European society of Cardiology. "Use of PCI [percutaneous coronary intervention] in patients with high SYNTAX scores should be seriously discouraged unless their operative risk is prohibitively high," said Dr. Shiomi, a cardiologist at Kyoto University Hospital, Japan. The registry results "suggested that the clinical outcome of PCI is not comparable with CABG even in patients with low syntax scores."

But the study’s findings also suggested that a selection bias occurred that even the risk-adjusted analysis used by Dr. Shiomi and his associates failed to adequately control, commented Dr. Uwe Zeymer, an interventional cardiologist and professor at the Institute for Myocardial Infarction Research in Ludwigshafen, Germany.

A major clue that selection bias came into play was that all-cause death during the 3-year follow-up of the study was 62% higher among the patients who underwent PCI, compared with those who underwent CABG, a statistically significant difference; in contrast, the rate of cardiac death was not significantly different between the CABG and PCI patients.

This discrepancy "says there was selection bias. Physicians had to decide what to do with patients who had a lot of comorbidities," and most of those patients probably underwent PCI, Dr. Zeymer said in an interview. "If the patients [undergoing PCI and CABG] were the same clinically, you’d expect that with PCI you would at least have the same result" for all-cause mortality. "There seems to have been a selection bias toward using PCI in patients with more comorbidities.

"What we can say is that in this real-world situation, cardiac mortality was the same" with both revascularization methods, "which is reassuring for the use of PCI," he added.

CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) enrolled more than 13,000 patients who underwent coronary revascularization at any of 26 Japanese centers during 2005-2007, a period when all PCIs used a drug-eluting coronary stent. The current analysis focused on 2,981 patients with triple vessel disease and no left main coronary disease or acute MI, and included 1,825 who were treated with CABG and 1,156 treated by PCI. The average age of the PCI patients was 70 years; the CABG patients averaged 68 years old.

After 1 year of follow-up, the combined rate of death, MI, or stroke was 23% higher in the patients treated with PCI, compared with those treated with CABG, a statistically significant difference in an unadjusted analysis for the study’s primary end point. After adjustment for baseline differences between the CABG and PCI patients, the rate of this combined end point was 47% higher among the PCI patients, also a statistically significant difference.

Analysis of several secondary end points showed a mixed pattern of differences between the two treatment groups in the adjusted analyses. A statistically significant difference in favor of fewer events with CABG occurred in the end point of all-cause death, which was 62% higher with PCI, as well as in the end point of MI, which was 2.39-fold higher in the PCI group. The protection against MI by CABG, compared with PCI, was "particularly remarkable," Dr. Shiomi said. But the end points of cardiac death and stroke showed no statistically significant differences between the two treatment groups in either the unadjusted or adjusted analyses.

Dr. Shiomi said that baseline SYNTAX scores were available for 94% of the patients. The mean score was 24 in the PCI patients and 30 for the CABG patients.

Dr. Shiomi said he had no disclosures. Dr. Zeymer said that the Institute of MI Research in Germany, where he works, has received research grant support from multiple cardiac-device companies.

PARIS – Coronary artery bypass grafting surpassed percutaneous coronary intervention in a "real-world," registry of patients with three-vessel coronary disease, largely confirming the findings of the SYNTAX trial in patients with high SYNTAX scores and in those with low scores.

However, because the new data – obtained at 26 Japanese centers during 2005-2007 and involving nearly 3,000 patients – came from a nonrandomized registry, it may have been flawed by selection biases that skewed which patients underwent bypass surgery and which ones had percutaneous revascularization.

Coronary artery bypass grafting (CABG) "remains the standard treatment option for patients with triple-vessel disease, even when their SYNTAX scores are high," Dr. Hiroki Shiomi said at the annual congress of the European society of Cardiology. "Use of PCI [percutaneous coronary intervention] in patients with high SYNTAX scores should be seriously discouraged unless their operative risk is prohibitively high," said Dr. Shiomi, a cardiologist at Kyoto University Hospital, Japan. The registry results "suggested that the clinical outcome of PCI is not comparable with CABG even in patients with low syntax scores."

But the study’s findings also suggested that a selection bias occurred that even the risk-adjusted analysis used by Dr. Shiomi and his associates failed to adequately control, commented Dr. Uwe Zeymer, an interventional cardiologist and professor at the Institute for Myocardial Infarction Research in Ludwigshafen, Germany.

A major clue that selection bias came into play was that all-cause death during the 3-year follow-up of the study was 62% higher among the patients who underwent PCI, compared with those who underwent CABG, a statistically significant difference; in contrast, the rate of cardiac death was not significantly different between the CABG and PCI patients.

This discrepancy "says there was selection bias. Physicians had to decide what to do with patients who had a lot of comorbidities," and most of those patients probably underwent PCI, Dr. Zeymer said in an interview. "If the patients [undergoing PCI and CABG] were the same clinically, you’d expect that with PCI you would at least have the same result" for all-cause mortality. "There seems to have been a selection bias toward using PCI in patients with more comorbidities.

"What we can say is that in this real-world situation, cardiac mortality was the same" with both revascularization methods, "which is reassuring for the use of PCI," he added.

CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) enrolled more than 13,000 patients who underwent coronary revascularization at any of 26 Japanese centers during 2005-2007, a period when all PCIs used a drug-eluting coronary stent. The current analysis focused on 2,981 patients with triple vessel disease and no left main coronary disease or acute MI, and included 1,825 who were treated with CABG and 1,156 treated by PCI. The average age of the PCI patients was 70 years; the CABG patients averaged 68 years old.

After 1 year of follow-up, the combined rate of death, MI, or stroke was 23% higher in the patients treated with PCI, compared with those treated with CABG, a statistically significant difference in an unadjusted analysis for the study’s primary end point. After adjustment for baseline differences between the CABG and PCI patients, the rate of this combined end point was 47% higher among the PCI patients, also a statistically significant difference.

Analysis of several secondary end points showed a mixed pattern of differences between the two treatment groups in the adjusted analyses. A statistically significant difference in favor of fewer events with CABG occurred in the end point of all-cause death, which was 62% higher with PCI, as well as in the end point of MI, which was 2.39-fold higher in the PCI group. The protection against MI by CABG, compared with PCI, was "particularly remarkable," Dr. Shiomi said. But the end points of cardiac death and stroke showed no statistically significant differences between the two treatment groups in either the unadjusted or adjusted analyses.

Dr. Shiomi said that baseline SYNTAX scores were available for 94% of the patients. The mean score was 24 in the PCI patients and 30 for the CABG patients.

Dr. Shiomi said he had no disclosures. Dr. Zeymer said that the Institute of MI Research in Germany, where he works, has received research grant support from multiple cardiac-device companies.

PARIS – Coronary artery bypass grafting surpassed percutaneous coronary intervention in a "real-world," registry of patients with three-vessel coronary disease, largely confirming the findings of the SYNTAX trial in patients with high SYNTAX scores and in those with low scores.

However, because the new data – obtained at 26 Japanese centers during 2005-2007 and involving nearly 3,000 patients – came from a nonrandomized registry, it may have been flawed by selection biases that skewed which patients underwent bypass surgery and which ones had percutaneous revascularization.

Coronary artery bypass grafting (CABG) "remains the standard treatment option for patients with triple-vessel disease, even when their SYNTAX scores are high," Dr. Hiroki Shiomi said at the annual congress of the European society of Cardiology. "Use of PCI [percutaneous coronary intervention] in patients with high SYNTAX scores should be seriously discouraged unless their operative risk is prohibitively high," said Dr. Shiomi, a cardiologist at Kyoto University Hospital, Japan. The registry results "suggested that the clinical outcome of PCI is not comparable with CABG even in patients with low syntax scores."

But the study’s findings also suggested that a selection bias occurred that even the risk-adjusted analysis used by Dr. Shiomi and his associates failed to adequately control, commented Dr. Uwe Zeymer, an interventional cardiologist and professor at the Institute for Myocardial Infarction Research in Ludwigshafen, Germany.

A major clue that selection bias came into play was that all-cause death during the 3-year follow-up of the study was 62% higher among the patients who underwent PCI, compared with those who underwent CABG, a statistically significant difference; in contrast, the rate of cardiac death was not significantly different between the CABG and PCI patients.

This discrepancy "says there was selection bias. Physicians had to decide what to do with patients who had a lot of comorbidities," and most of those patients probably underwent PCI, Dr. Zeymer said in an interview. "If the patients [undergoing PCI and CABG] were the same clinically, you’d expect that with PCI you would at least have the same result" for all-cause mortality. "There seems to have been a selection bias toward using PCI in patients with more comorbidities.

"What we can say is that in this real-world situation, cardiac mortality was the same" with both revascularization methods, "which is reassuring for the use of PCI," he added.

CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) enrolled more than 13,000 patients who underwent coronary revascularization at any of 26 Japanese centers during 2005-2007, a period when all PCIs used a drug-eluting coronary stent. The current analysis focused on 2,981 patients with triple vessel disease and no left main coronary disease or acute MI, and included 1,825 who were treated with CABG and 1,156 treated by PCI. The average age of the PCI patients was 70 years; the CABG patients averaged 68 years old.

After 1 year of follow-up, the combined rate of death, MI, or stroke was 23% higher in the patients treated with PCI, compared with those treated with CABG, a statistically significant difference in an unadjusted analysis for the study’s primary end point. After adjustment for baseline differences between the CABG and PCI patients, the rate of this combined end point was 47% higher among the PCI patients, also a statistically significant difference.

Analysis of several secondary end points showed a mixed pattern of differences between the two treatment groups in the adjusted analyses. A statistically significant difference in favor of fewer events with CABG occurred in the end point of all-cause death, which was 62% higher with PCI, as well as in the end point of MI, which was 2.39-fold higher in the PCI group. The protection against MI by CABG, compared with PCI, was "particularly remarkable," Dr. Shiomi said. But the end points of cardiac death and stroke showed no statistically significant differences between the two treatment groups in either the unadjusted or adjusted analyses.

Dr. Shiomi said that baseline SYNTAX scores were available for 94% of the patients. The mean score was 24 in the PCI patients and 30 for the CABG patients.

Dr. Shiomi said he had no disclosures. Dr. Zeymer said that the Institute of MI Research in Germany, where he works, has received research grant support from multiple cardiac-device companies.

PARIS – A cardiac rehabilitation program can help cerebrovascular-disease patients as much as it helps patients with cardiac disease, based on results from 89 patients treated in a Canadian pilot program.

"Patients suffering a non-disabling stroke or TIA [transient ischemic attack] gain the same, if not better, outcomes from being part of a multifactorial, risk-reduction program traditionally offered to patients with coronary artery disease," said Dr. Nicholas B. Giacomantonio at the annual congress of the European Society of Cardiology. "We believe programs such as Hearts in Motion should be the standard of care for all patients with established vascular disease."

Based on the positive results from the pilot study, run at three sites in Nova Scotia, referral of patients following stroke or TIA to cardiac rehabilitation programs modeled on Community Cardiovascular Hearts in Motion are now operating at two additional Nova Scotia sites as well at several locations in New Brunswick. The total of about a dozen sites are testing the efficacy of a standard, 12-week cardiac rehabilitation program of diet, exercise, and education against usual care in a prospective study (BMC Neurol. 2010;10:122), said Dr. Giacomantonio, a cardiologist and director of cardiac rehabilitation at Dalhousie University in Halifax, N.S.

The three Nova Scotia sites that ran programs for the pilot phase of Hearts in Motion – a small regional hospital, a sports complex, and a drug store – began enrolling patients in 2006 to the 3-month intervention, and by 2010 the program had 12-month follow-up data on a total of 705 patients. In addition to the 89 patients enrolled following a nondisabling stroke or TIA, the programs enrolled 397 patients with coronary artery disease, 12 with peripheral artery disease, and 207 people for primary prevention. As of last August, a total of about 1,400 people had enrolled at the first three Hearts in Motion sites, but follow-up on the other roughly 700 patients had not yet reached at least 1 year.

The program directly targets family physicians as a source for referrals, Dr. Giacomantonio said. Other referral sources are specialist physicians and hospitals. Following stroke or TIA, patients entered the program after an average of 4 weeks. Among enrolled patients, 94% completed the 3-month program (defined as attending at least 80% of the 36 hours of classes), 87% completed 6-month follow-up, and 77% returned for a 12-month follow-up assessment. He attributed the excellent retention rate to "family physicians who refer patients who are likely motivated to attend the program."

The "traditional" cardiac rehabilitation program used by Hearts in Motion includes 2 hours per week of supervised exercise and 1 hour each week of education, along with referrals to ancillary programs when needed, such as smoking cessation. The participants averaged 62 years old, and 10% of the cerebrovascular patients were current smokers. During the 3-month intervention, participating patients generally did not undergo any changes in their medical management.

"We believe programs such as Hearts in Motion should be the standard of care for all patients with established vascular disease."

The most dramatic changes in risk profile occurred in functional capacity, measured as metabolic equivalents (METs). The 60 post-stroke or TIA patients without diabetes averaged a 27% improvement in METs at the end of the 3-month intervention, while the 29 post–cerebrovascular disease patients with diabetes averaged a 29% boost in METs after the 3-month program, increases comparable to the 18% and 21% METs rises in the coronary artery disease patients with or without diabetes, respectively.

Retention of the functional improvement fared somewhat less well in the post-stroke and TIA patients without diabetes at 12-month follow-up, when these patients averaged a 0.9 METs increase over baseline. Cerebrovascular disease patients with diabetes had an average 1.6-MET increase at their 12-month follow-up compared with baseline, similar to the 1.6-MET and 1.4-MET improvements over baseline seen in the two coronary disease subgroups at 12-months. A 1.6-MET improvement sustained over 12 months corresponds to a roughly 12% reduced risk for cardiovascular disease death, Dr. Giacomantonio noted.

By other measures, the post-stroke and TIA patients tracked close to their coronary disease counterparts. Systolic blood pressure fell by an average of 4% in the coronary group and 3% in the cerebrovascular disease patients, diastolic pressure dropped by averages of 3% and 2% in the two subgroups, respectively, and LDL-cholesterol levels dropped by an average of 1% and 4%. All patients lost an average of 1 inch in waist circumference regardless of their subgroup. Depression and anxiety scores also dropped by similar amounts in the coronary- and cerebrovascular-disease subgroups.

Dr. Giacomantonio and his associates are currently analyzing cost data from the pilot program, and plan to have those results available in about a year. They suspect the intervention will save more from cardiovascular events prevented than the cost of offering the program to patients following cerebrovascular events, he said.

Dr. Giacomantonio said that he had no disclosures.

PARIS – A cardiac rehabilitation program can help cerebrovascular-disease patients as much as it helps patients with cardiac disease, based on results from 89 patients treated in a Canadian pilot program.

"Patients suffering a non-disabling stroke or TIA [transient ischemic attack] gain the same, if not better, outcomes from being part of a multifactorial, risk-reduction program traditionally offered to patients with coronary artery disease," said Dr. Nicholas B. Giacomantonio at the annual congress of the European Society of Cardiology. "We believe programs such as Hearts in Motion should be the standard of care for all patients with established vascular disease."

Based on the positive results from the pilot study, run at three sites in Nova Scotia, referral of patients following stroke or TIA to cardiac rehabilitation programs modeled on Community Cardiovascular Hearts in Motion are now operating at two additional Nova Scotia sites as well at several locations in New Brunswick. The total of about a dozen sites are testing the efficacy of a standard, 12-week cardiac rehabilitation program of diet, exercise, and education against usual care in a prospective study (BMC Neurol. 2010;10:122), said Dr. Giacomantonio, a cardiologist and director of cardiac rehabilitation at Dalhousie University in Halifax, N.S.

The three Nova Scotia sites that ran programs for the pilot phase of Hearts in Motion – a small regional hospital, a sports complex, and a drug store – began enrolling patients in 2006 to the 3-month intervention, and by 2010 the program had 12-month follow-up data on a total of 705 patients. In addition to the 89 patients enrolled following a nondisabling stroke or TIA, the programs enrolled 397 patients with coronary artery disease, 12 with peripheral artery disease, and 207 people for primary prevention. As of last August, a total of about 1,400 people had enrolled at the first three Hearts in Motion sites, but follow-up on the other roughly 700 patients had not yet reached at least 1 year.

The program directly targets family physicians as a source for referrals, Dr. Giacomantonio said. Other referral sources are specialist physicians and hospitals. Following stroke or TIA, patients entered the program after an average of 4 weeks. Among enrolled patients, 94% completed the 3-month program (defined as attending at least 80% of the 36 hours of classes), 87% completed 6-month follow-up, and 77% returned for a 12-month follow-up assessment. He attributed the excellent retention rate to "family physicians who refer patients who are likely motivated to attend the program."

The "traditional" cardiac rehabilitation program used by Hearts in Motion includes 2 hours per week of supervised exercise and 1 hour each week of education, along with referrals to ancillary programs when needed, such as smoking cessation. The participants averaged 62 years old, and 10% of the cerebrovascular patients were current smokers. During the 3-month intervention, participating patients generally did not undergo any changes in their medical management.

"We believe programs such as Hearts in Motion should be the standard of care for all patients with established vascular disease."

The most dramatic changes in risk profile occurred in functional capacity, measured as metabolic equivalents (METs). The 60 post-stroke or TIA patients without diabetes averaged a 27% improvement in METs at the end of the 3-month intervention, while the 29 post–cerebrovascular disease patients with diabetes averaged a 29% boost in METs after the 3-month program, increases comparable to the 18% and 21% METs rises in the coronary artery disease patients with or without diabetes, respectively.

Retention of the functional improvement fared somewhat less well in the post-stroke and TIA patients without diabetes at 12-month follow-up, when these patients averaged a 0.9 METs increase over baseline. Cerebrovascular disease patients with diabetes had an average 1.6-MET increase at their 12-month follow-up compared with baseline, similar to the 1.6-MET and 1.4-MET improvements over baseline seen in the two coronary disease subgroups at 12-months. A 1.6-MET improvement sustained over 12 months corresponds to a roughly 12% reduced risk for cardiovascular disease death, Dr. Giacomantonio noted.

By other measures, the post-stroke and TIA patients tracked close to their coronary disease counterparts. Systolic blood pressure fell by an average of 4% in the coronary group and 3% in the cerebrovascular disease patients, diastolic pressure dropped by averages of 3% and 2% in the two subgroups, respectively, and LDL-cholesterol levels dropped by an average of 1% and 4%. All patients lost an average of 1 inch in waist circumference regardless of their subgroup. Depression and anxiety scores also dropped by similar amounts in the coronary- and cerebrovascular-disease subgroups.

Dr. Giacomantonio and his associates are currently analyzing cost data from the pilot program, and plan to have those results available in about a year. They suspect the intervention will save more from cardiovascular events prevented than the cost of offering the program to patients following cerebrovascular events, he said.

Dr. Giacomantonio said that he had no disclosures.

PARIS – A cardiac rehabilitation program can help cerebrovascular-disease patients as much as it helps patients with cardiac disease, based on results from 89 patients treated in a Canadian pilot program.

"Patients suffering a non-disabling stroke or TIA [transient ischemic attack] gain the same, if not better, outcomes from being part of a multifactorial, risk-reduction program traditionally offered to patients with coronary artery disease," said Dr. Nicholas B. Giacomantonio at the annual congress of the European Society of Cardiology. "We believe programs such as Hearts in Motion should be the standard of care for all patients with established vascular disease."

Based on the positive results from the pilot study, run at three sites in Nova Scotia, referral of patients following stroke or TIA to cardiac rehabilitation programs modeled on Community Cardiovascular Hearts in Motion are now operating at two additional Nova Scotia sites as well at several locations in New Brunswick. The total of about a dozen sites are testing the efficacy of a standard, 12-week cardiac rehabilitation program of diet, exercise, and education against usual care in a prospective study (BMC Neurol. 2010;10:122), said Dr. Giacomantonio, a cardiologist and director of cardiac rehabilitation at Dalhousie University in Halifax, N.S.

The three Nova Scotia sites that ran programs for the pilot phase of Hearts in Motion – a small regional hospital, a sports complex, and a drug store – began enrolling patients in 2006 to the 3-month intervention, and by 2010 the program had 12-month follow-up data on a total of 705 patients. In addition to the 89 patients enrolled following a nondisabling stroke or TIA, the programs enrolled 397 patients with coronary artery disease, 12 with peripheral artery disease, and 207 people for primary prevention. As of last August, a total of about 1,400 people had enrolled at the first three Hearts in Motion sites, but follow-up on the other roughly 700 patients had not yet reached at least 1 year.

The program directly targets family physicians as a source for referrals, Dr. Giacomantonio said. Other referral sources are specialist physicians and hospitals. Following stroke or TIA, patients entered the program after an average of 4 weeks. Among enrolled patients, 94% completed the 3-month program (defined as attending at least 80% of the 36 hours of classes), 87% completed 6-month follow-up, and 77% returned for a 12-month follow-up assessment. He attributed the excellent retention rate to "family physicians who refer patients who are likely motivated to attend the program."

The "traditional" cardiac rehabilitation program used by Hearts in Motion includes 2 hours per week of supervised exercise and 1 hour each week of education, along with referrals to ancillary programs when needed, such as smoking cessation. The participants averaged 62 years old, and 10% of the cerebrovascular patients were current smokers. During the 3-month intervention, participating patients generally did not undergo any changes in their medical management.

"We believe programs such as Hearts in Motion should be the standard of care for all patients with established vascular disease."

The most dramatic changes in risk profile occurred in functional capacity, measured as metabolic equivalents (METs). The 60 post-stroke or TIA patients without diabetes averaged a 27% improvement in METs at the end of the 3-month intervention, while the 29 post–cerebrovascular disease patients with diabetes averaged a 29% boost in METs after the 3-month program, increases comparable to the 18% and 21% METs rises in the coronary artery disease patients with or without diabetes, respectively.

Retention of the functional improvement fared somewhat less well in the post-stroke and TIA patients without diabetes at 12-month follow-up, when these patients averaged a 0.9 METs increase over baseline. Cerebrovascular disease patients with diabetes had an average 1.6-MET increase at their 12-month follow-up compared with baseline, similar to the 1.6-MET and 1.4-MET improvements over baseline seen in the two coronary disease subgroups at 12-months. A 1.6-MET improvement sustained over 12 months corresponds to a roughly 12% reduced risk for cardiovascular disease death, Dr. Giacomantonio noted.

By other measures, the post-stroke and TIA patients tracked close to their coronary disease counterparts. Systolic blood pressure fell by an average of 4% in the coronary group and 3% in the cerebrovascular disease patients, diastolic pressure dropped by averages of 3% and 2% in the two subgroups, respectively, and LDL-cholesterol levels dropped by an average of 1% and 4%. All patients lost an average of 1 inch in waist circumference regardless of their subgroup. Depression and anxiety scores also dropped by similar amounts in the coronary- and cerebrovascular-disease subgroups.

Dr. Giacomantonio and his associates are currently analyzing cost data from the pilot program, and plan to have those results available in about a year. They suspect the intervention will save more from cardiovascular events prevented than the cost of offering the program to patients following cerebrovascular events, he said.

Dr. Giacomantonio said that he had no disclosures.

PARIS – The heart rate lowering agent, ivabradine, significantly improved left ventricular volume indexes and left ventricular ejection fraction in patients with heart failure and systolic dysfunction, according to the findings of an echocardiography substudy of a large randomized controlled trial.

"These results suggest that ivabradine modifies disease progression in patients with heart failure receiving background therapy," Dr. Jean-Claude Tardif said at the annual congress of the European Society of Cardiology. The results are also clinically important because left ventricular enlargement and reduced ejection fraction are powerful predictors of outcomes in heart failure.

Notably, among the 411 patients analyzed, those who had the greatest reduction in heart rate had better remodeling and outcomes.

Investigators reported at last year’s congress that in SHIFT (Systolic Heart Failure Treatment With the I_f Inhibitor Ivabradine Trial), ivabradine (Procoralan), a selective I_f channel blocker, led to an 18% reduction in the composite primary end point of cardiovascular death and heart failure hospitalization, compared with placebo, in 6,558 patients with chronic heart failure, a left ventricular ejection fraction (LVEF) of 35% or less, and resting heart rate of at least 70 beats per minute (Lancet 2010;376:875-85).

In the prespecified substudy, echocardiography was used to assess left ventricular modeling in 208 patients treated with ivabradine, 5 mg twice daily, and 203 patients given placebo. Baseline background treatment included beta-blockers (92%), an ACE inhibitor/angiotensin-receptor blocker (96%), or an aldosterone antagonist (72%). Their mean LVEF was 32%.

Eight months of treatment with ivabradine resulted in a statistically significant 7 mL/m² reduction in the primary end point of left ventricular end-systolic volume index (LVESVI), compared with a 0.9 mL/m² reduction in the placebo group (P = .0002), reported Dr. Tardif, with the Montreal Heart Institute at the University of Montreal. The change in LVESVI was independent of beta-blocker use, heart failure etiology and baseline LVEF.

A reduction in LVESVI of at least 15% was observed in significantly more patients with ivabradine than placebo (38% vs. 25%, P = .005)

Ivabradine significantly improved the secondary end points of left ventricular end-diastolic volume index (-7.9 mL/m² vs. -1.8 mL/m², P = .002) and LVEF (2.4% vs. -0.1%, P = .0003), he said.

Significantly more patients experienced a clinically relevant improvement in LVEF of 5% or more with ivabradine than placebo (36% vs. 23%, P = .003).

"The significant reductions in LV volumes in favor of ivabradine were parallel with the reduction in heart rate at eight months achieved with ivabradine versus placebo [-14.7 bpm vs. -5.8 bpm, P less than .0001]," Dr. Tardif said.

Discussant Dr. Burkert Pieske, with the division of cardiology at the Medical University of Graz (Austria), said that the substudy findings underscore the importance of reverse remodeling as a marker for improved outcome, and provides solid, mechanistic data to encourage the use of ivabradine as an add-on medication in patients in sinus rhythm and a heart rate above 7 beats/minute.

"The reduction in LVESVI of about 6 mL/m² is more or less comparable with other pharmacologic interventions, and importantly it adds on to the beneficial effect of beta blockers and ACE inhibitors," he said.

In contrast to cardiac resynchronization, ivabradine can be started by every heart failure physician without great expense, Dr. Pieske and his colleague Dr. Friedrich Fruhwald, wrote in an accompanying editorial in the European Heart Journal (Eur. Heart J. 2011 Sept. 2 [doi:10.1093/eurheartj/ehr317]).

They pointed out, however, that ivabradine only works in heart failure patients with sinus rhythm and that relevant reverse modeling was seen in only a third of these patients.

"So, we have to identify the right patients we need to treat with ivabradine," said Dr. Pieske, adding that further testing is warranted in such conditions as acute heart failure or heart failure with preserved ejection fraction.

Findings from a second SHIFT substudy suggest that reduction in heart rate with ivabradine is associated with improved health-related quality of life.

At 12 months, the change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score was significantly greater in the ivabradine group than the placebo group (6.7 vs. 4.3, P less than .001).

This also was true for the KCCQ clinical summary score (5.0 vs. 3.3, P = .018), reported Dr. Inger Ekman from the Institute of Health Care Sciences, Sahlgrenska Academy in Gothenburg, Sweden. A change of 5 units is considered a clinically meaningful change in KCCQ scoring.

The magnitude of heart rate reduction with ivabradine was directly related to the degree of improvement in health-related quality of life, she said.

Among the 1,944 patients in the substudy, the incidence of cardiovascular death or heart failure hospitalization at 12 months was inversely associated with KCCQ scores.

Dr. Ekman pointed out that recommended therapies with survival benefits like beta blockers have no impact on health-related quality of life, while some therapies that improve quality of life like inotropic agents do not improve survival.

Dr. Tardif and Dr. Ekman reported that all the study’s authors have received fees, research grants or both from the study sponsor, Servier. Dr. Pieske reported having no relevant disclosures.

PARIS – The heart rate lowering agent, ivabradine, significantly improved left ventricular volume indexes and left ventricular ejection fraction in patients with heart failure and systolic dysfunction, according to the findings of an echocardiography substudy of a large randomized controlled trial.

"These results suggest that ivabradine modifies disease progression in patients with heart failure receiving background therapy," Dr. Jean-Claude Tardif said at the annual congress of the European Society of Cardiology. The results are also clinically important because left ventricular enlargement and reduced ejection fraction are powerful predictors of outcomes in heart failure.

Notably, among the 411 patients analyzed, those who had the greatest reduction in heart rate had better remodeling and outcomes.

Investigators reported at last year’s congress that in SHIFT (Systolic Heart Failure Treatment With the I_f Inhibitor Ivabradine Trial), ivabradine (Procoralan), a selective I_f channel blocker, led to an 18% reduction in the composite primary end point of cardiovascular death and heart failure hospitalization, compared with placebo, in 6,558 patients with chronic heart failure, a left ventricular ejection fraction (LVEF) of 35% or less, and resting heart rate of at least 70 beats per minute (Lancet 2010;376:875-85).

In the prespecified substudy, echocardiography was used to assess left ventricular modeling in 208 patients treated with ivabradine, 5 mg twice daily, and 203 patients given placebo. Baseline background treatment included beta-blockers (92%), an ACE inhibitor/angiotensin-receptor blocker (96%), or an aldosterone antagonist (72%). Their mean LVEF was 32%.

Eight months of treatment with ivabradine resulted in a statistically significant 7 mL/m² reduction in the primary end point of left ventricular end-systolic volume index (LVESVI), compared with a 0.9 mL/m² reduction in the placebo group (P = .0002), reported Dr. Tardif, with the Montreal Heart Institute at the University of Montreal. The change in LVESVI was independent of beta-blocker use, heart failure etiology and baseline LVEF.

A reduction in LVESVI of at least 15% was observed in significantly more patients with ivabradine than placebo (38% vs. 25%, P = .005)

Ivabradine significantly improved the secondary end points of left ventricular end-diastolic volume index (-7.9 mL/m² vs. -1.8 mL/m², P = .002) and LVEF (2.4% vs. -0.1%, P = .0003), he said.

Significantly more patients experienced a clinically relevant improvement in LVEF of 5% or more with ivabradine than placebo (36% vs. 23%, P = .003).

"The significant reductions in LV volumes in favor of ivabradine were parallel with the reduction in heart rate at eight months achieved with ivabradine versus placebo [-14.7 bpm vs. -5.8 bpm, P less than .0001]," Dr. Tardif said.

Discussant Dr. Burkert Pieske, with the division of cardiology at the Medical University of Graz (Austria), said that the substudy findings underscore the importance of reverse remodeling as a marker for improved outcome, and provides solid, mechanistic data to encourage the use of ivabradine as an add-on medication in patients in sinus rhythm and a heart rate above 7 beats/minute.

"The reduction in LVESVI of about 6 mL/m² is more or less comparable with other pharmacologic interventions, and importantly it adds on to the beneficial effect of beta blockers and ACE inhibitors," he said.

In contrast to cardiac resynchronization, ivabradine can be started by every heart failure physician without great expense, Dr. Pieske and his colleague Dr. Friedrich Fruhwald, wrote in an accompanying editorial in the European Heart Journal (Eur. Heart J. 2011 Sept. 2 [doi:10.1093/eurheartj/ehr317]).

They pointed out, however, that ivabradine only works in heart failure patients with sinus rhythm and that relevant reverse modeling was seen in only a third of these patients.

"So, we have to identify the right patients we need to treat with ivabradine," said Dr. Pieske, adding that further testing is warranted in such conditions as acute heart failure or heart failure with preserved ejection fraction.

Findings from a second SHIFT substudy suggest that reduction in heart rate with ivabradine is associated with improved health-related quality of life.

At 12 months, the change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score was significantly greater in the ivabradine group than the placebo group (6.7 vs. 4.3, P less than .001).

This also was true for the KCCQ clinical summary score (5.0 vs. 3.3, P = .018), reported Dr. Inger Ekman from the Institute of Health Care Sciences, Sahlgrenska Academy in Gothenburg, Sweden. A change of 5 units is considered a clinically meaningful change in KCCQ scoring.

The magnitude of heart rate reduction with ivabradine was directly related to the degree of improvement in health-related quality of life, she said.

Among the 1,944 patients in the substudy, the incidence of cardiovascular death or heart failure hospitalization at 12 months was inversely associated with KCCQ scores.

Dr. Ekman pointed out that recommended therapies with survival benefits like beta blockers have no impact on health-related quality of life, while some therapies that improve quality of life like inotropic agents do not improve survival.

Dr. Tardif and Dr. Ekman reported that all the study’s authors have received fees, research grants or both from the study sponsor, Servier. Dr. Pieske reported having no relevant disclosures.

PARIS – The heart rate lowering agent, ivabradine, significantly improved left ventricular volume indexes and left ventricular ejection fraction in patients with heart failure and systolic dysfunction, according to the findings of an echocardiography substudy of a large randomized controlled trial.

"These results suggest that ivabradine modifies disease progression in patients with heart failure receiving background therapy," Dr. Jean-Claude Tardif said at the annual congress of the European Society of Cardiology. The results are also clinically important because left ventricular enlargement and reduced ejection fraction are powerful predictors of outcomes in heart failure.

Notably, among the 411 patients analyzed, those who had the greatest reduction in heart rate had better remodeling and outcomes.

Investigators reported at last year’s congress that in SHIFT (Systolic Heart Failure Treatment With the I_f Inhibitor Ivabradine Trial), ivabradine (Procoralan), a selective I_f channel blocker, led to an 18% reduction in the composite primary end point of cardiovascular death and heart failure hospitalization, compared with placebo, in 6,558 patients with chronic heart failure, a left ventricular ejection fraction (LVEF) of 35% or less, and resting heart rate of at least 70 beats per minute (Lancet 2010;376:875-85).

In the prespecified substudy, echocardiography was used to assess left ventricular modeling in 208 patients treated with ivabradine, 5 mg twice daily, and 203 patients given placebo. Baseline background treatment included beta-blockers (92%), an ACE inhibitor/angiotensin-receptor blocker (96%), or an aldosterone antagonist (72%). Their mean LVEF was 32%.

Eight months of treatment with ivabradine resulted in a statistically significant 7 mL/m² reduction in the primary end point of left ventricular end-systolic volume index (LVESVI), compared with a 0.9 mL/m² reduction in the placebo group (P = .0002), reported Dr. Tardif, with the Montreal Heart Institute at the University of Montreal. The change in LVESVI was independent of beta-blocker use, heart failure etiology and baseline LVEF.

A reduction in LVESVI of at least 15% was observed in significantly more patients with ivabradine than placebo (38% vs. 25%, P = .005)

Ivabradine significantly improved the secondary end points of left ventricular end-diastolic volume index (-7.9 mL/m² vs. -1.8 mL/m², P = .002) and LVEF (2.4% vs. -0.1%, P = .0003), he said.

Significantly more patients experienced a clinically relevant improvement in LVEF of 5% or more with ivabradine than placebo (36% vs. 23%, P = .003).

"The significant reductions in LV volumes in favor of ivabradine were parallel with the reduction in heart rate at eight months achieved with ivabradine versus placebo [-14.7 bpm vs. -5.8 bpm, P less than .0001]," Dr. Tardif said.

Discussant Dr. Burkert Pieske, with the division of cardiology at the Medical University of Graz (Austria), said that the substudy findings underscore the importance of reverse remodeling as a marker for improved outcome, and provides solid, mechanistic data to encourage the use of ivabradine as an add-on medication in patients in sinus rhythm and a heart rate above 7 beats/minute.

"The reduction in LVESVI of about 6 mL/m² is more or less comparable with other pharmacologic interventions, and importantly it adds on to the beneficial effect of beta blockers and ACE inhibitors," he said.

In contrast to cardiac resynchronization, ivabradine can be started by every heart failure physician without great expense, Dr. Pieske and his colleague Dr. Friedrich Fruhwald, wrote in an accompanying editorial in the European Heart Journal (Eur. Heart J. 2011 Sept. 2 [doi:10.1093/eurheartj/ehr317]).

They pointed out, however, that ivabradine only works in heart failure patients with sinus rhythm and that relevant reverse modeling was seen in only a third of these patients.

"So, we have to identify the right patients we need to treat with ivabradine," said Dr. Pieske, adding that further testing is warranted in such conditions as acute heart failure or heart failure with preserved ejection fraction.

Findings from a second SHIFT substudy suggest that reduction in heart rate with ivabradine is associated with improved health-related quality of life.

At 12 months, the change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score was significantly greater in the ivabradine group than the placebo group (6.7 vs. 4.3, P less than .001).

This also was true for the KCCQ clinical summary score (5.0 vs. 3.3, P = .018), reported Dr. Inger Ekman from the Institute of Health Care Sciences, Sahlgrenska Academy in Gothenburg, Sweden. A change of 5 units is considered a clinically meaningful change in KCCQ scoring.

The magnitude of heart rate reduction with ivabradine was directly related to the degree of improvement in health-related quality of life, she said.

Among the 1,944 patients in the substudy, the incidence of cardiovascular death or heart failure hospitalization at 12 months was inversely associated with KCCQ scores.

Dr. Ekman pointed out that recommended therapies with survival benefits like beta blockers have no impact on health-related quality of life, while some therapies that improve quality of life like inotropic agents do not improve survival.

Dr. Tardif and Dr. Ekman reported that all the study’s authors have received fees, research grants or both from the study sponsor, Servier. Dr. Pieske reported having no relevant disclosures.

PARIS – A cardiovascular risk reduction program based on lifestyle changes and implemented in primary care practices led to substantial risk reductions over 1 year in a pilot study of 560 patients.

People who think "we shouldn’t spend a lot of time or effort on behavioral modification, that it doesn’t get us anywhere" are wrong, said Dr. Jafna L. Cox, a cardiologist and research director of the division of cardiology at Dalhousie University in Halifax, N.S.

One caveat, however, is that participation required an initial behavior assessment aimed at identifying people who were willing to make lifestyle changes in the first place.

The behavioral modification interventions included goal setting, stimulus control, and changes in the stress management techniques used by participants, Dr. Cox said at the annual congress of the European Society of Cardiology. For example, people who used smoking or eating as their major stress management strategies underwent training to shift to healthier stress management methods, such as exercise.

The resources and skills that made this pilot program work "are readily imported into any practice type," he stressed.

The study’s primary end point was the percentage of people with an intermediate 10-year risk whose risk fell by at least 10 percentage points, plus the percentage of people with a high Framingham Risk Score (FRS) at baseline whose score fell by at least 25 percentage points. This end point was achieved by 43% of people in the intervention group and by 31% of those in the comparison group, a statistically significant difference.

The study’s secondary end point, the percentage of people whose FRS strata dropped by at least one risk category, occurred in 39% of those in the intervention group and in 25% of those in the comparison group, also a statistically significant difference. For every seven people who participated in the intervention program, one person achieved at least one category reduction in cardiovascular risk level beyond what occurred in a control group that received no special intervention.

Furthermore, the lifestyle changes were associated with an average 6-mm Hg reduction in systolic blood pressure, an average 4-mm Hg drop in diastolic blood pressure, an average 2-kg reduction in weight, and an average 3.5-cm cut in waist circumference.

"This was as good as the best drug in a hypertension or weight-reduction trial," said Dr. Blair J. O’Neill, director and professor of cardiology at the University of Alberta in Edmonton, and a collaborator on the study.

The investigation, known as ANCHOR (A Novel Approach to Cardiovascular Health By Optimizing Risk Management) study, enrolled 1,509 people aged 30 years or older from two primary care practices in Nova Scotia, from a five-physician practice in Halifax, and from a 10-physician practice in Sydney. All participants underwent a baseline cardiovascular risk assessment with the FRS that divided them according to their estimated 10-year risk for a cardiovascular event into low-risk (less than 10% risk), intermediate-risk (10%-20% risk), or high-risk (greater than 20% risk) groups.

The current study excluded people with either diabetes or identified cardiovascular disease at baseline, and focused on the 560 people who fell into the intermediate- or high-risk groups. The study also included 67 people from a third Nova Scotia primary care practice in either the intermediate- or high-risk categories who received no special intervention; they were the comparison group. The average age of those in the intervention group was 55 years, 58% were women, and their average 10-year risk for an event was 18%. In the comparison group, the average age was 60 years, 36% were women, and their average 10-year risk was 20%.

The percentage of participants with metabolic syndrome dropped from baseline by 25 percentage points in the intervention group, and by 14 percentage points in the comparison group.

The favorable changes in the intervention group occurred without any significant changes in the medications they received, compared with baseline. For example, the prevalence of prescriptions for lipid-lowering drugs actually fell, from 8% at baseline to 7% after 1 year. The largest change in the prevalence of antihypertensive medications prescribed was in the category of ACE inhibitors, which rose from 8% of patients at baseline to 11% of patients after 1 year.

Dr. Cox attributed the improvement in the comparator group to their participation in the study, a Hawthorne effect, especially because ANCHOR received a lot of media attention in Nova Scotia. "We suspect that these [comparator] patients had an increase in their medications, especially blood pressure–lowering drugs," he said.

After representatives from local health authorities heard the results, Dr. Cox said that they began encouraging other local primary care physicians to routinely perform baseline cardiovascular risk assessments using the FRS, and to incorporate behavioral modification programs into their practices by training their nursing staffs.

In addition to an expanded program, both within Nova Scotia and in other Canadian provinces, Dr. Cox and his associates plan to examine ways to maintain the positive changes triggered by the intervention.

ANCHOR was supported by a research grant from Pfizer Canada. Dr. Cox and Dr. O’Neill reported having no relevant conflicts of interest.

PARIS – A cardiovascular risk reduction program based on lifestyle changes and implemented in primary care practices led to substantial risk reductions over 1 year in a pilot study of 560 patients.

People who think "we shouldn’t spend a lot of time or effort on behavioral modification, that it doesn’t get us anywhere" are wrong, said Dr. Jafna L. Cox, a cardiologist and research director of the division of cardiology at Dalhousie University in Halifax, N.S.

One caveat, however, is that participation required an initial behavior assessment aimed at identifying people who were willing to make lifestyle changes in the first place.

The behavioral modification interventions included goal setting, stimulus control, and changes in the stress management techniques used by participants, Dr. Cox said at the annual congress of the European Society of Cardiology. For example, people who used smoking or eating as their major stress management strategies underwent training to shift to healthier stress management methods, such as exercise.

The resources and skills that made this pilot program work "are readily imported into any practice type," he stressed.

The study’s primary end point was the percentage of people with an intermediate 10-year risk whose risk fell by at least 10 percentage points, plus the percentage of people with a high Framingham Risk Score (FRS) at baseline whose score fell by at least 25 percentage points. This end point was achieved by 43% of people in the intervention group and by 31% of those in the comparison group, a statistically significant difference.

The study’s secondary end point, the percentage of people whose FRS strata dropped by at least one risk category, occurred in 39% of those in the intervention group and in 25% of those in the comparison group, also a statistically significant difference. For every seven people who participated in the intervention program, one person achieved at least one category reduction in cardiovascular risk level beyond what occurred in a control group that received no special intervention.

Furthermore, the lifestyle changes were associated with an average 6-mm Hg reduction in systolic blood pressure, an average 4-mm Hg drop in diastolic blood pressure, an average 2-kg reduction in weight, and an average 3.5-cm cut in waist circumference.

"This was as good as the best drug in a hypertension or weight-reduction trial," said Dr. Blair J. O’Neill, director and professor of cardiology at the University of Alberta in Edmonton, and a collaborator on the study.

The investigation, known as ANCHOR (A Novel Approach to Cardiovascular Health By Optimizing Risk Management) study, enrolled 1,509 people aged 30 years or older from two primary care practices in Nova Scotia, from a five-physician practice in Halifax, and from a 10-physician practice in Sydney. All participants underwent a baseline cardiovascular risk assessment with the FRS that divided them according to their estimated 10-year risk for a cardiovascular event into low-risk (less than 10% risk), intermediate-risk (10%-20% risk), or high-risk (greater than 20% risk) groups.

The current study excluded people with either diabetes or identified cardiovascular disease at baseline, and focused on the 560 people who fell into the intermediate- or high-risk groups. The study also included 67 people from a third Nova Scotia primary care practice in either the intermediate- or high-risk categories who received no special intervention; they were the comparison group. The average age of those in the intervention group was 55 years, 58% were women, and their average 10-year risk for an event was 18%. In the comparison group, the average age was 60 years, 36% were women, and their average 10-year risk was 20%.

The percentage of participants with metabolic syndrome dropped from baseline by 25 percentage points in the intervention group, and by 14 percentage points in the comparison group.

The favorable changes in the intervention group occurred without any significant changes in the medications they received, compared with baseline. For example, the prevalence of prescriptions for lipid-lowering drugs actually fell, from 8% at baseline to 7% after 1 year. The largest change in the prevalence of antihypertensive medications prescribed was in the category of ACE inhibitors, which rose from 8% of patients at baseline to 11% of patients after 1 year.

Dr. Cox attributed the improvement in the comparator group to their participation in the study, a Hawthorne effect, especially because ANCHOR received a lot of media attention in Nova Scotia. "We suspect that these [comparator] patients had an increase in their medications, especially blood pressure–lowering drugs," he said.

After representatives from local health authorities heard the results, Dr. Cox said that they began encouraging other local primary care physicians to routinely perform baseline cardiovascular risk assessments using the FRS, and to incorporate behavioral modification programs into their practices by training their nursing staffs.

In addition to an expanded program, both within Nova Scotia and in other Canadian provinces, Dr. Cox and his associates plan to examine ways to maintain the positive changes triggered by the intervention.

ANCHOR was supported by a research grant from Pfizer Canada. Dr. Cox and Dr. O’Neill reported having no relevant conflicts of interest.

PARIS – A cardiovascular risk reduction program based on lifestyle changes and implemented in primary care practices led to substantial risk reductions over 1 year in a pilot study of 560 patients.

People who think "we shouldn’t spend a lot of time or effort on behavioral modification, that it doesn’t get us anywhere" are wrong, said Dr. Jafna L. Cox, a cardiologist and research director of the division of cardiology at Dalhousie University in Halifax, N.S.

One caveat, however, is that participation required an initial behavior assessment aimed at identifying people who were willing to make lifestyle changes in the first place.

The behavioral modification interventions included goal setting, stimulus control, and changes in the stress management techniques used by participants, Dr. Cox said at the annual congress of the European Society of Cardiology. For example, people who used smoking or eating as their major stress management strategies underwent training to shift to healthier stress management methods, such as exercise.

The resources and skills that made this pilot program work "are readily imported into any practice type," he stressed.

The study’s primary end point was the percentage of people with an intermediate 10-year risk whose risk fell by at least 10 percentage points, plus the percentage of people with a high Framingham Risk Score (FRS) at baseline whose score fell by at least 25 percentage points. This end point was achieved by 43% of people in the intervention group and by 31% of those in the comparison group, a statistically significant difference.

The study’s secondary end point, the percentage of people whose FRS strata dropped by at least one risk category, occurred in 39% of those in the intervention group and in 25% of those in the comparison group, also a statistically significant difference. For every seven people who participated in the intervention program, one person achieved at least one category reduction in cardiovascular risk level beyond what occurred in a control group that received no special intervention.

Furthermore, the lifestyle changes were associated with an average 6-mm Hg reduction in systolic blood pressure, an average 4-mm Hg drop in diastolic blood pressure, an average 2-kg reduction in weight, and an average 3.5-cm cut in waist circumference.

"This was as good as the best drug in a hypertension or weight-reduction trial," said Dr. Blair J. O’Neill, director and professor of cardiology at the University of Alberta in Edmonton, and a collaborator on the study.

The investigation, known as ANCHOR (A Novel Approach to Cardiovascular Health By Optimizing Risk Management) study, enrolled 1,509 people aged 30 years or older from two primary care practices in Nova Scotia, from a five-physician practice in Halifax, and from a 10-physician practice in Sydney. All participants underwent a baseline cardiovascular risk assessment with the FRS that divided them according to their estimated 10-year risk for a cardiovascular event into low-risk (less than 10% risk), intermediate-risk (10%-20% risk), or high-risk (greater than 20% risk) groups.

The current study excluded people with either diabetes or identified cardiovascular disease at baseline, and focused on the 560 people who fell into the intermediate- or high-risk groups. The study also included 67 people from a third Nova Scotia primary care practice in either the intermediate- or high-risk categories who received no special intervention; they were the comparison group. The average age of those in the intervention group was 55 years, 58% were women, and their average 10-year risk for an event was 18%. In the comparison group, the average age was 60 years, 36% were women, and their average 10-year risk was 20%.

The percentage of participants with metabolic syndrome dropped from baseline by 25 percentage points in the intervention group, and by 14 percentage points in the comparison group.

The favorable changes in the intervention group occurred without any significant changes in the medications they received, compared with baseline. For example, the prevalence of prescriptions for lipid-lowering drugs actually fell, from 8% at baseline to 7% after 1 year. The largest change in the prevalence of antihypertensive medications prescribed was in the category of ACE inhibitors, which rose from 8% of patients at baseline to 11% of patients after 1 year.

Dr. Cox attributed the improvement in the comparator group to their participation in the study, a Hawthorne effect, especially because ANCHOR received a lot of media attention in Nova Scotia. "We suspect that these [comparator] patients had an increase in their medications, especially blood pressure–lowering drugs," he said.

After representatives from local health authorities heard the results, Dr. Cox said that they began encouraging other local primary care physicians to routinely perform baseline cardiovascular risk assessments using the FRS, and to incorporate behavioral modification programs into their practices by training their nursing staffs.

In addition to an expanded program, both within Nova Scotia and in other Canadian provinces, Dr. Cox and his associates plan to examine ways to maintain the positive changes triggered by the intervention.

ANCHOR was supported by a research grant from Pfizer Canada. Dr. Cox and Dr. O’Neill reported having no relevant conflicts of interest.

PARIS – Worse long-term outcomes after high-emergency heart transplants in patients bridged to transplant with cardiac assist devices seem to be related to more complex transplant procedures for those patients rather than differences in patients or donors, a registry study suggests.

The study compared data on 107 patients who had been supported with short-term ventricular assist devices (VADs) and 597 patients supported with conventional therapy before high-emergency heart transplantation (defined by United Network for Organ Sharing status 1 criteria). Data came from 15 centers in the Spanish National Heart Transplant Registry in 2000-2009.

In the postoperative period, rates of primary graft failure and major bleeding were higher among VAD patients than among the conventional group (39% vs. 22%, and 33% vs. 23%, respectively). Furthermore, 22% in the VAD group and 14% in the conventional group required cardiac reoperation. These differences between groups were statistically significant, Dr. Eduardo Barge-Caballero and his associates reported in a press briefing at the annual congress of the European Society of Cardiology.

There was a trend toward higher risk of in-hospital death after surgery in the VAD group (36%) compared with the conventional group (27%), but this did not reach statistical significance. Approximately 60% of patients in the VAD group survived a year after transplantation compared with about 70% of patients in the conventional group.

Long-term survival rates differed significantly between groups by the first year after heart transplantation after adjustment for confounding variables, but the differences were not significant at 10 years of follow-up, said Dr. Barge-Caballero of Hospital Universitario A Coruña, Spain.

Concerns about potential adverse impacts of short-term VAD on outcomes after high-emergency heart transplantation have been cited previously. It has been suggested that these adverse impacts may have been caused by the VAD patients being in worse clinical condition, undergoing more difficult procedures with bleeding complications and infections caused by removal of the VAD, receiving less-desirable donor hearts, or being at a higher risk of rejection.

The current study, which compared the clinical characteristics of donor hearts and recipients in the VAD and conventional groups, concluded that donors were similar between groups and recipients were "not drastically different" between groups, Dr. Barge-Caballero said.

Two kinds of VADs were implanted: Forty-nine patients got extracorporeal continuous-flow devices, and 58 patients received paracorporeal pulsatile-flow devices. There was a trend toward a higher risk of bleeding with the paracorporeal pulsatile-flow devices, but there were not enough patients in each group to show a significant difference, he said.

Patients supported by VAD were significantly younger than were those receiving conventional bridge therapy (48 vs. 51 years, respectively) and were more likely to be female (37% vs. 17%) and to have had previous cardiac surgery (53% vs. 20%). Before VAD implantation, patients in the VAD group received higher doses of intravenous inotropes than did patients in the conventional group.

Measures of end-organ function such as creatinine and bilirubin were similar between groups. Donor organs were similar between groups in age, cold ischemia time, and other characteristics.

The surgical bypass time was significantly longer in the VAD group (156 minutes) than in the conventional group (133 minutes), which may reflect more complicated heart transplantation surgery in the VAD group, he suggested.

Patients spent a mean of only 5 days on bridge support with VAD or conventional bridge therapy, including intra-aortic balloon pump and/or IV inotropes, invasive mechanical ventilation, and dialysis.

Stable patients awaiting high-emergency heart transplantation in countries with short waiting lists should not routinely get VADs, Dr. Barge-Caballero suggested. Because of their risks, VADs should be reserved for critically ill patients who deteriorate when conventional therapy does not provide adequate peripheral perfusion to avoid irreversible end-organ damage.

"Routine implantation of a short-term VAD is not a good option for all patients undergoing a high-emergency heart transplantation," Dr. Barge-Caballero said. "It’s evident that if the patient is really not doing well, has severe hemodynamic instability, [and] is not well with conventional support, we have to implant a VAD. But it’s not, in our opinion, a good option for all patients."

Dr. Barge-Caballero said the investigators had no relevant conflicts of interest.

PARIS – Worse long-term outcomes after high-emergency heart transplants in patients bridged to transplant with cardiac assist devices seem to be related to more complex transplant procedures for those patients rather than differences in patients or donors, a registry study suggests.

The study compared data on 107 patients who had been supported with short-term ventricular assist devices (VADs) and 597 patients supported with conventional therapy before high-emergency heart transplantation (defined by United Network for Organ Sharing status 1 criteria). Data came from 15 centers in the Spanish National Heart Transplant Registry in 2000-2009.

In the postoperative period, rates of primary graft failure and major bleeding were higher among VAD patients than among the conventional group (39% vs. 22%, and 33% vs. 23%, respectively). Furthermore, 22% in the VAD group and 14% in the conventional group required cardiac reoperation. These differences between groups were statistically significant, Dr. Eduardo Barge-Caballero and his associates reported in a press briefing at the annual congress of the European Society of Cardiology.

There was a trend toward higher risk of in-hospital death after surgery in the VAD group (36%) compared with the conventional group (27%), but this did not reach statistical significance. Approximately 60% of patients in the VAD group survived a year after transplantation compared with about 70% of patients in the conventional group.

Long-term survival rates differed significantly between groups by the first year after heart transplantation after adjustment for confounding variables, but the differences were not significant at 10 years of follow-up, said Dr. Barge-Caballero of Hospital Universitario A Coruña, Spain.

Concerns about potential adverse impacts of short-term VAD on outcomes after high-emergency heart transplantation have been cited previously. It has been suggested that these adverse impacts may have been caused by the VAD patients being in worse clinical condition, undergoing more difficult procedures with bleeding complications and infections caused by removal of the VAD, receiving less-desirable donor hearts, or being at a higher risk of rejection.

The current study, which compared the clinical characteristics of donor hearts and recipients in the VAD and conventional groups, concluded that donors were similar between groups and recipients were "not drastically different" between groups, Dr. Barge-Caballero said.

Two kinds of VADs were implanted: Forty-nine patients got extracorporeal continuous-flow devices, and 58 patients received paracorporeal pulsatile-flow devices. There was a trend toward a higher risk of bleeding with the paracorporeal pulsatile-flow devices, but there were not enough patients in each group to show a significant difference, he said.

Patients supported by VAD were significantly younger than were those receiving conventional bridge therapy (48 vs. 51 years, respectively) and were more likely to be female (37% vs. 17%) and to have had previous cardiac surgery (53% vs. 20%). Before VAD implantation, patients in the VAD group received higher doses of intravenous inotropes than did patients in the conventional group.

Measures of end-organ function such as creatinine and bilirubin were similar between groups. Donor organs were similar between groups in age, cold ischemia time, and other characteristics.

The surgical bypass time was significantly longer in the VAD group (156 minutes) than in the conventional group (133 minutes), which may reflect more complicated heart transplantation surgery in the VAD group, he suggested.

Patients spent a mean of only 5 days on bridge support with VAD or conventional bridge therapy, including intra-aortic balloon pump and/or IV inotropes, invasive mechanical ventilation, and dialysis.

Stable patients awaiting high-emergency heart transplantation in countries with short waiting lists should not routinely get VADs, Dr. Barge-Caballero suggested. Because of their risks, VADs should be reserved for critically ill patients who deteriorate when conventional therapy does not provide adequate peripheral perfusion to avoid irreversible end-organ damage.

"Routine implantation of a short-term VAD is not a good option for all patients undergoing a high-emergency heart transplantation," Dr. Barge-Caballero said. "It’s evident that if the patient is really not doing well, has severe hemodynamic instability, [and] is not well with conventional support, we have to implant a VAD. But it’s not, in our opinion, a good option for all patients."

Dr. Barge-Caballero said the investigators had no relevant conflicts of interest.

PARIS – Worse long-term outcomes after high-emergency heart transplants in patients bridged to transplant with cardiac assist devices seem to be related to more complex transplant procedures for those patients rather than differences in patients or donors, a registry study suggests.

The study compared data on 107 patients who had been supported with short-term ventricular assist devices (VADs) and 597 patients supported with conventional therapy before high-emergency heart transplantation (defined by United Network for Organ Sharing status 1 criteria). Data came from 15 centers in the Spanish National Heart Transplant Registry in 2000-2009.

In the postoperative period, rates of primary graft failure and major bleeding were higher among VAD patients than among the conventional group (39% vs. 22%, and 33% vs. 23%, respectively). Furthermore, 22% in the VAD group and 14% in the conventional group required cardiac reoperation. These differences between groups were statistically significant, Dr. Eduardo Barge-Caballero and his associates reported in a press briefing at the annual congress of the European Society of Cardiology.

There was a trend toward higher risk of in-hospital death after surgery in the VAD group (36%) compared with the conventional group (27%), but this did not reach statistical significance. Approximately 60% of patients in the VAD group survived a year after transplantation compared with about 70% of patients in the conventional group.

Long-term survival rates differed significantly between groups by the first year after heart transplantation after adjustment for confounding variables, but the differences were not significant at 10 years of follow-up, said Dr. Barge-Caballero of Hospital Universitario A Coruña, Spain.

Concerns about potential adverse impacts of short-term VAD on outcomes after high-emergency heart transplantation have been cited previously. It has been suggested that these adverse impacts may have been caused by the VAD patients being in worse clinical condition, undergoing more difficult procedures with bleeding complications and infections caused by removal of the VAD, receiving less-desirable donor hearts, or being at a higher risk of rejection.

The current study, which compared the clinical characteristics of donor hearts and recipients in the VAD and conventional groups, concluded that donors were similar between groups and recipients were "not drastically different" between groups, Dr. Barge-Caballero said.

Two kinds of VADs were implanted: Forty-nine patients got extracorporeal continuous-flow devices, and 58 patients received paracorporeal pulsatile-flow devices. There was a trend toward a higher risk of bleeding with the paracorporeal pulsatile-flow devices, but there were not enough patients in each group to show a significant difference, he said.

Patients supported by VAD were significantly younger than were those receiving conventional bridge therapy (48 vs. 51 years, respectively) and were more likely to be female (37% vs. 17%) and to have had previous cardiac surgery (53% vs. 20%). Before VAD implantation, patients in the VAD group received higher doses of intravenous inotropes than did patients in the conventional group.

Measures of end-organ function such as creatinine and bilirubin were similar between groups. Donor organs were similar between groups in age, cold ischemia time, and other characteristics.

The surgical bypass time was significantly longer in the VAD group (156 minutes) than in the conventional group (133 minutes), which may reflect more complicated heart transplantation surgery in the VAD group, he suggested.

Patients spent a mean of only 5 days on bridge support with VAD or conventional bridge therapy, including intra-aortic balloon pump and/or IV inotropes, invasive mechanical ventilation, and dialysis.

Stable patients awaiting high-emergency heart transplantation in countries with short waiting lists should not routinely get VADs, Dr. Barge-Caballero suggested. Because of their risks, VADs should be reserved for critically ill patients who deteriorate when conventional therapy does not provide adequate peripheral perfusion to avoid irreversible end-organ damage.

"Routine implantation of a short-term VAD is not a good option for all patients undergoing a high-emergency heart transplantation," Dr. Barge-Caballero said. "It’s evident that if the patient is really not doing well, has severe hemodynamic instability, [and] is not well with conventional support, we have to implant a VAD. But it’s not, in our opinion, a good option for all patients."

Dr. Barge-Caballero said the investigators had no relevant conflicts of interest.

PARIS – The notable safety of the everolimus-eluting coronary stent in a prospective, randomized trial with about 1,500 patients with acute ST elevation myocardial infarctions may change the stent choice that many interventional cardiologists make when treating these patients.

Until now, interventionalists have often shied away from placing a drug-eluting coronary stent on an emergency basis in acute myocardial infarction (MI) patients undergoing primary percutaneous coronary intervention because it is often hard to assess the future ability of these patients to remain on dual-antiplatelet therapy for a year to cut their risk of stent thrombosis.

The new results, obtained in an all-comer trial in which 70% of presenting acute ST elevation MI (STEMI) patients qualified to enter the trial, showed that dual-antiplatelet therapy compliance ran 95% during the 1-year follow-up and that patients who received an everolimus-eluting stent had a substantially reduced stent thrombosis rate, compared with patients who received a bare metal stent, Dr. Manel Sabaté reported at the annual meeting of the European Society of Cardiology.

"The findings support the safety and efficacy profile of the Xience V [everolimus-eluting coronary] stent in a widely representative cohort of patients presenting with STEMI," said Dr. Sabaté, chief of cardiology at the Hospital Clinic in Barcelona.

"The results of this trial are reassuring. With first-generation drug-eluting stents [sirolimus- and paclitaxel-eluting stents], there was concern about stent thrombosis in STEMI. These data say that the everolimus-eluting stent is even safer than a bare metal stent. For the first time, you can feel reassured that you can implant a drug-eluting stent in patients with STEMI using the same criteria as in patients without acute coronary syndrome," Dr. Sabaté said.

In the EXAMINATION (Clinical Evaluation of Xience-V Stent in Acute Myocardial Infarction) trial during the first year of follow-up, definite or probable stent thrombosis occurred in 0.90% of patients who received an everolimus-eluting stent, and in 2.35% of those who received a bare-metal, cobalt-chromium stent, a statistically significant difference for this prespecified, secondary end point of the study. The study’s primary end point, the 1-year composite rate of all-cause death, MI, or any revascularization, occurred in 14.4% of the patients who received a bare-metal stent and in 12% of those who received an everolimus-eluting stent, a difference that did not achieve statistical significance.

Many cardiologists who heard the results viewed them as practice changing, although at least one expert cautioned that, strictly speaking, the secondary findings should be considered hypothesis generating only because the study failed to prove its primary end point.

"The trial was not powered for stent thrombosis" as a primary end point, commented Dr. William Wijns, a cardiologist at the Cardiovascular Research Center in Aalst, Belgium. Current treatment recommendations from the European Society of Cardiology say that an interventionalist could use a drug-eluting stent to treat a STEMI to reduce the patient’s risk for restenosis, "provided you feel comfortable with the patient’s [future] use of dual-antiplatelet therapy," he said in an interview.

Often with STEMI patients, that comfort level does not exist because "you can’t interrogate the patient and you don’t know the patient’s history, so you have to be cautious about drug-eluting stents." In addition, there was concern about stent thrombosis. "That’s where this result will change the perception," he said. "I cannot say the results change the evidence, because the trial did not reach its primary end point. A rigorous analysis would say this trial is only hypothesis generating, but some negative trials do influence practice. And it also comes as yet another piece of evidence regarding the new generation drug-eluting stents, and this brand of stent in particular. This is another positive signal" for the safety of the everolimus-eluting stent. "The signal is a reduced risk with the second-generation drug-eluting stent. It’s a fantastic opportunity," Dr. Wijns said.

Other experts were less guarded in foreseeing important treatment implications from the results.

"The data are very convincing," commented Dr. P. Gabriel Steg, a professor of cardiology at the University of Paris and director of the coronary care unit at the Bichat-Claude Bernard Hospital, also in Paris. "The results "will probably change the view of the interventional community and may possibly change the guidelines with respect to using a drug-eluting stent in this setting. To have a result with confidence, we’ll need a large trial, but this smaller trial points in a reassuring direction. What I like about the trial is its generalizability, because they enrolled 70% of their [STEMI] patients. The results are only from 1 year, and we need to remember that some of the concerns about drug-eluting stents in STEMI patients relate to late events. But the results are very reassuring in this setting for up to 1 year."

"When you compare the new generation of drug-eluting stents with the first generation, there is a significant improvement in safety. The limitation of drug-eluting stents was stent thrombosis, and we see with the new generation that this disappears," commented Dr. Jean Fajadet, codirector of the interventional cardiology unit at the Pasteur Clinic in Toulouse, France, and president of the European Association of Percutaneous Cardiac Interventions.

"What is important [in this trial] was the all-comer population. With the second-generation drug-eluting stents we see reduced restenosis and need for repeat revascularization and, at the same time, better safety. That is really important. This is one more step to lead interventionalists to be more aggressive in using drug-eluting stents in STEMI patients. But whatever drug-eluting stent is used, what’s also important is the patient’s tolerance of dual-antiplatelet therapy," said Dr. Fajadet in an interview.

He recommended more liberalized use of everolimus-eluting stents in STEMI patients who are well suited to remaining on dual-antiplatelet therapy for a year, while taking a more cautious approach in patients who are poor candidates for prolonged dual-antiplatelet therapy. A good candidate would be a STEMI patient who is relatively young – in his or her 50s or 60s – has no know comorbidities, and gives negative answers to a series of questions in the emergency room: Do you have a history of gastrointestinal bleeding, a history of cancer, a history of stroke, or an allergy to aspirin, and do you have any planned major surgery?

A patient who answers yes to one or more of these questions, or someone who is more than 75 years old or has comorbidities is less likely to reliably stay on dual-antiplatelet therapy for a year and probably should not receive an everolimus-eluting stent for an acute STEMI, Dr. Fajadet said.

The EXAMINATION trial ran at 12 centers in Spain, Italy, and the Netherlands, initially enrolled 1,498 patients, and had 1-year follow-up on 98%. The patients averaged 62 years old, and about 83% were men. More than 80% of the patients entered the study within 12 hours of the start of their STEMI, although enrollment was allowed up to 48 hours after the onset. Compliance with the daily aspirin and clopidogrel regimen during the first year following stenting ran 95% in the patients who received an everolimus-eluting stent and 90% among the patients who received a bare-metal stent. During the 1-year follow-up, the rates of cardiac death and MI were similar in the two subgroups, but for the secondary end point of need for a repeat target lesion or target vessel revascularization procedure, the patients who received the everolimus-eluting stent had, as expected, a significantly reduced rate, compared with patients who received a bare-metal stent. The target lesion revascularization rate was an absolute 2.9% lower and the target vessel rate was an absolute 3.1% lower with drug-eluting stents, compared with bare-metal stents, Dr. Sabaté reported.

EXAMINATION was supported by the Spanish Heart Foundation, which received an unrestricted grant from Abbott, the company that markets the everolimus-eluting coronary stent (Xience V). Dr. Sabaté said that he did not have any disclosures. Dr. Wijns said that any consulting fees or honoraria he receives go directly to the Cardiovascular Research Center, which has performed contracted research for numerous firms, including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Abbott Vascular, Biotronik, Boston Scientific, Cordis, Johnson & Johnson, Edwards, Medtronic, and St. Jude. The Cardiovascular Research Center also cofounded Cardio BioSciences. Dr. Steg said that he has received speaking or consulting honoraria from numerous drug and device companies including AstraZeneca, Bayer, Medtronic, Merck, Pfizer, Roche, and Sanofi-Aventis; that he is a stockholder in Aterovax; and that he has received a research grant from Servier. Dr. Fajadet said that he had no disclosures.

PARIS – The notable safety of the everolimus-eluting coronary stent in a prospective, randomized trial with about 1,500 patients with acute ST elevation myocardial infarctions may change the stent choice that many interventional cardiologists make when treating these patients.

Until now, interventionalists have often shied away from placing a drug-eluting coronary stent on an emergency basis in acute myocardial infarction (MI) patients undergoing primary percutaneous coronary intervention because it is often hard to assess the future ability of these patients to remain on dual-antiplatelet therapy for a year to cut their risk of stent thrombosis.

The new results, obtained in an all-comer trial in which 70% of presenting acute ST elevation MI (STEMI) patients qualified to enter the trial, showed that dual-antiplatelet therapy compliance ran 95% during the 1-year follow-up and that patients who received an everolimus-eluting stent had a substantially reduced stent thrombosis rate, compared with patients who received a bare metal stent, Dr. Manel Sabaté reported at the annual meeting of the European Society of Cardiology.

"The findings support the safety and efficacy profile of the Xience V [everolimus-eluting coronary] stent in a widely representative cohort of patients presenting with STEMI," said Dr. Sabaté, chief of cardiology at the Hospital Clinic in Barcelona.

"The results of this trial are reassuring. With first-generation drug-eluting stents [sirolimus- and paclitaxel-eluting stents], there was concern about stent thrombosis in STEMI. These data say that the everolimus-eluting stent is even safer than a bare metal stent. For the first time, you can feel reassured that you can implant a drug-eluting stent in patients with STEMI using the same criteria as in patients without acute coronary syndrome," Dr. Sabaté said.

In the EXAMINATION (Clinical Evaluation of Xience-V Stent in Acute Myocardial Infarction) trial during the first year of follow-up, definite or probable stent thrombosis occurred in 0.90% of patients who received an everolimus-eluting stent, and in 2.35% of those who received a bare-metal, cobalt-chromium stent, a statistically significant difference for this prespecified, secondary end point of the study. The study’s primary end point, the 1-year composite rate of all-cause death, MI, or any revascularization, occurred in 14.4% of the patients who received a bare-metal stent and in 12% of those who received an everolimus-eluting stent, a difference that did not achieve statistical significance.

Many cardiologists who heard the results viewed them as practice changing, although at least one expert cautioned that, strictly speaking, the secondary findings should be considered hypothesis generating only because the study failed to prove its primary end point.

"The trial was not powered for stent thrombosis" as a primary end point, commented Dr. William Wijns, a cardiologist at the Cardiovascular Research Center in Aalst, Belgium. Current treatment recommendations from the European Society of Cardiology say that an interventionalist could use a drug-eluting stent to treat a STEMI to reduce the patient’s risk for restenosis, "provided you feel comfortable with the patient’s [future] use of dual-antiplatelet therapy," he said in an interview.

Often with STEMI patients, that comfort level does not exist because "you can’t interrogate the patient and you don’t know the patient’s history, so you have to be cautious about drug-eluting stents." In addition, there was concern about stent thrombosis. "That’s where this result will change the perception," he said. "I cannot say the results change the evidence, because the trial did not reach its primary end point. A rigorous analysis would say this trial is only hypothesis generating, but some negative trials do influence practice. And it also comes as yet another piece of evidence regarding the new generation drug-eluting stents, and this brand of stent in particular. This is another positive signal" for the safety of the everolimus-eluting stent. "The signal is a reduced risk with the second-generation drug-eluting stent. It’s a fantastic opportunity," Dr. Wijns said.

Other experts were less guarded in foreseeing important treatment implications from the results.

"The data are very convincing," commented Dr. P. Gabriel Steg, a professor of cardiology at the University of Paris and director of the coronary care unit at the Bichat-Claude Bernard Hospital, also in Paris. "The results "will probably change the view of the interventional community and may possibly change the guidelines with respect to using a drug-eluting stent in this setting. To have a result with confidence, we’ll need a large trial, but this smaller trial points in a reassuring direction. What I like about the trial is its generalizability, because they enrolled 70% of their [STEMI] patients. The results are only from 1 year, and we need to remember that some of the concerns about drug-eluting stents in STEMI patients relate to late events. But the results are very reassuring in this setting for up to 1 year."

"When you compare the new generation of drug-eluting stents with the first generation, there is a significant improvement in safety. The limitation of drug-eluting stents was stent thrombosis, and we see with the new generation that this disappears," commented Dr. Jean Fajadet, codirector of the interventional cardiology unit at the Pasteur Clinic in Toulouse, France, and president of the European Association of Percutaneous Cardiac Interventions.

"What is important [in this trial] was the all-comer population. With the second-generation drug-eluting stents we see reduced restenosis and need for repeat revascularization and, at the same time, better safety. That is really important. This is one more step to lead interventionalists to be more aggressive in using drug-eluting stents in STEMI patients. But whatever drug-eluting stent is used, what’s also important is the patient’s tolerance of dual-antiplatelet therapy," said Dr. Fajadet in an interview.

He recommended more liberalized use of everolimus-eluting stents in STEMI patients who are well suited to remaining on dual-antiplatelet therapy for a year, while taking a more cautious approach in patients who are poor candidates for prolonged dual-antiplatelet therapy. A good candidate would be a STEMI patient who is relatively young – in his or her 50s or 60s – has no know comorbidities, and gives negative answers to a series of questions in the emergency room: Do you have a history of gastrointestinal bleeding, a history of cancer, a history of stroke, or an allergy to aspirin, and do you have any planned major surgery?

A patient who answers yes to one or more of these questions, or someone who is more than 75 years old or has comorbidities is less likely to reliably stay on dual-antiplatelet therapy for a year and probably should not receive an everolimus-eluting stent for an acute STEMI, Dr. Fajadet said.

The EXAMINATION trial ran at 12 centers in Spain, Italy, and the Netherlands, initially enrolled 1,498 patients, and had 1-year follow-up on 98%. The patients averaged 62 years old, and about 83% were men. More than 80% of the patients entered the study within 12 hours of the start of their STEMI, although enrollment was allowed up to 48 hours after the onset. Compliance with the daily aspirin and clopidogrel regimen during the first year following stenting ran 95% in the patients who received an everolimus-eluting stent and 90% among the patients who received a bare-metal stent. During the 1-year follow-up, the rates of cardiac death and MI were similar in the two subgroups, but for the secondary end point of need for a repeat target lesion or target vessel revascularization procedure, the patients who received the everolimus-eluting stent had, as expected, a significantly reduced rate, compared with patients who received a bare-metal stent. The target lesion revascularization rate was an absolute 2.9% lower and the target vessel rate was an absolute 3.1% lower with drug-eluting stents, compared with bare-metal stents, Dr. Sabaté reported.

EXAMINATION was supported by the Spanish Heart Foundation, which received an unrestricted grant from Abbott, the company that markets the everolimus-eluting coronary stent (Xience V). Dr. Sabaté said that he did not have any disclosures. Dr. Wijns said that any consulting fees or honoraria he receives go directly to the Cardiovascular Research Center, which has performed contracted research for numerous firms, including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Abbott Vascular, Biotronik, Boston Scientific, Cordis, Johnson & Johnson, Edwards, Medtronic, and St. Jude. The Cardiovascular Research Center also cofounded Cardio BioSciences. Dr. Steg said that he has received speaking or consulting honoraria from numerous drug and device companies including AstraZeneca, Bayer, Medtronic, Merck, Pfizer, Roche, and Sanofi-Aventis; that he is a stockholder in Aterovax; and that he has received a research grant from Servier. Dr. Fajadet said that he had no disclosures.

PARIS – The notable safety of the everolimus-eluting coronary stent in a prospective, randomized trial with about 1,500 patients with acute ST elevation myocardial infarctions may change the stent choice that many interventional cardiologists make when treating these patients.

Until now, interventionalists have often shied away from placing a drug-eluting coronary stent on an emergency basis in acute myocardial infarction (MI) patients undergoing primary percutaneous coronary intervention because it is often hard to assess the future ability of these patients to remain on dual-antiplatelet therapy for a year to cut their risk of stent thrombosis.

The new results, obtained in an all-comer trial in which 70% of presenting acute ST elevation MI (STEMI) patients qualified to enter the trial, showed that dual-antiplatelet therapy compliance ran 95% during the 1-year follow-up and that patients who received an everolimus-eluting stent had a substantially reduced stent thrombosis rate, compared with patients who received a bare metal stent, Dr. Manel Sabaté reported at the annual meeting of the European Society of Cardiology.

"The findings support the safety and efficacy profile of the Xience V [everolimus-eluting coronary] stent in a widely representative cohort of patients presenting with STEMI," said Dr. Sabaté, chief of cardiology at the Hospital Clinic in Barcelona.

"The results of this trial are reassuring. With first-generation drug-eluting stents [sirolimus- and paclitaxel-eluting stents], there was concern about stent thrombosis in STEMI. These data say that the everolimus-eluting stent is even safer than a bare metal stent. For the first time, you can feel reassured that you can implant a drug-eluting stent in patients with STEMI using the same criteria as in patients without acute coronary syndrome," Dr. Sabaté said.

In the EXAMINATION (Clinical Evaluation of Xience-V Stent in Acute Myocardial Infarction) trial during the first year of follow-up, definite or probable stent thrombosis occurred in 0.90% of patients who received an everolimus-eluting stent, and in 2.35% of those who received a bare-metal, cobalt-chromium stent, a statistically significant difference for this prespecified, secondary end point of the study. The study’s primary end point, the 1-year composite rate of all-cause death, MI, or any revascularization, occurred in 14.4% of the patients who received a bare-metal stent and in 12% of those who received an everolimus-eluting stent, a difference that did not achieve statistical significance.

Many cardiologists who heard the results viewed them as practice changing, although at least one expert cautioned that, strictly speaking, the secondary findings should be considered hypothesis generating only because the study failed to prove its primary end point.

"The trial was not powered for stent thrombosis" as a primary end point, commented Dr. William Wijns, a cardiologist at the Cardiovascular Research Center in Aalst, Belgium. Current treatment recommendations from the European Society of Cardiology say that an interventionalist could use a drug-eluting stent to treat a STEMI to reduce the patient’s risk for restenosis, "provided you feel comfortable with the patient’s [future] use of dual-antiplatelet therapy," he said in an interview.

Often with STEMI patients, that comfort level does not exist because "you can’t interrogate the patient and you don’t know the patient’s history, so you have to be cautious about drug-eluting stents." In addition, there was concern about stent thrombosis. "That’s where this result will change the perception," he said. "I cannot say the results change the evidence, because the trial did not reach its primary end point. A rigorous analysis would say this trial is only hypothesis generating, but some negative trials do influence practice. And it also comes as yet another piece of evidence regarding the new generation drug-eluting stents, and this brand of stent in particular. This is another positive signal" for the safety of the everolimus-eluting stent. "The signal is a reduced risk with the second-generation drug-eluting stent. It’s a fantastic opportunity," Dr. Wijns said.

Other experts were less guarded in foreseeing important treatment implications from the results.

"The data are very convincing," commented Dr. P. Gabriel Steg, a professor of cardiology at the University of Paris and director of the coronary care unit at the Bichat-Claude Bernard Hospital, also in Paris. "The results "will probably change the view of the interventional community and may possibly change the guidelines with respect to using a drug-eluting stent in this setting. To have a result with confidence, we’ll need a large trial, but this smaller trial points in a reassuring direction. What I like about the trial is its generalizability, because they enrolled 70% of their [STEMI] patients. The results are only from 1 year, and we need to remember that some of the concerns about drug-eluting stents in STEMI patients relate to late events. But the results are very reassuring in this setting for up to 1 year."

"When you compare the new generation of drug-eluting stents with the first generation, there is a significant improvement in safety. The limitation of drug-eluting stents was stent thrombosis, and we see with the new generation that this disappears," commented Dr. Jean Fajadet, codirector of the interventional cardiology unit at the Pasteur Clinic in Toulouse, France, and president of the European Association of Percutaneous Cardiac Interventions.

"What is important [in this trial] was the all-comer population. With the second-generation drug-eluting stents we see reduced restenosis and need for repeat revascularization and, at the same time, better safety. That is really important. This is one more step to lead interventionalists to be more aggressive in using drug-eluting stents in STEMI patients. But whatever drug-eluting stent is used, what’s also important is the patient’s tolerance of dual-antiplatelet therapy," said Dr. Fajadet in an interview.

He recommended more liberalized use of everolimus-eluting stents in STEMI patients who are well suited to remaining on dual-antiplatelet therapy for a year, while taking a more cautious approach in patients who are poor candidates for prolonged dual-antiplatelet therapy. A good candidate would be a STEMI patient who is relatively young – in his or her 50s or 60s – has no know comorbidities, and gives negative answers to a series of questions in the emergency room: Do you have a history of gastrointestinal bleeding, a history of cancer, a history of stroke, or an allergy to aspirin, and do you have any planned major surgery?

A patient who answers yes to one or more of these questions, or someone who is more than 75 years old or has comorbidities is less likely to reliably stay on dual-antiplatelet therapy for a year and probably should not receive an everolimus-eluting stent for an acute STEMI, Dr. Fajadet said.

The EXAMINATION trial ran at 12 centers in Spain, Italy, and the Netherlands, initially enrolled 1,498 patients, and had 1-year follow-up on 98%. The patients averaged 62 years old, and about 83% were men. More than 80% of the patients entered the study within 12 hours of the start of their STEMI, although enrollment was allowed up to 48 hours after the onset. Compliance with the daily aspirin and clopidogrel regimen during the first year following stenting ran 95% in the patients who received an everolimus-eluting stent and 90% among the patients who received a bare-metal stent. During the 1-year follow-up, the rates of cardiac death and MI were similar in the two subgroups, but for the secondary end point of need for a repeat target lesion or target vessel revascularization procedure, the patients who received the everolimus-eluting stent had, as expected, a significantly reduced rate, compared with patients who received a bare-metal stent. The target lesion revascularization rate was an absolute 2.9% lower and the target vessel rate was an absolute 3.1% lower with drug-eluting stents, compared with bare-metal stents, Dr. Sabaté reported.

EXAMINATION was supported by the Spanish Heart Foundation, which received an unrestricted grant from Abbott, the company that markets the everolimus-eluting coronary stent (Xience V). Dr. Sabaté said that he did not have any disclosures. Dr. Wijns said that any consulting fees or honoraria he receives go directly to the Cardiovascular Research Center, which has performed contracted research for numerous firms, including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Abbott Vascular, Biotronik, Boston Scientific, Cordis, Johnson & Johnson, Edwards, Medtronic, and St. Jude. The Cardiovascular Research Center also cofounded Cardio BioSciences. Dr. Steg said that he has received speaking or consulting honoraria from numerous drug and device companies including AstraZeneca, Bayer, Medtronic, Merck, Pfizer, Roche, and Sanofi-Aventis; that he is a stockholder in Aterovax; and that he has received a research grant from Servier. Dr. Fajadet said that he had no disclosures.

PARIS – A new algorithm incorporating high-sensitivity cardiac troponin T values in patients with ST-segment elevation seems to differentiate between MI and cardiac but noncoronary disease in patients with acute chest pain.

The algorithm could help triage patients in the first hour of presentation so that those who need coronary angiographies get them quickly and unnecessary angiographies are minimized, Dr. Philip Haaf said in a press briefing at the annual congress of the European Society of Cardiology.

Troponins are increased in cardiovascular disorders including tachyarrhythmia, heart failure, hypertensive urgency or emergency, Takotsubo cardiomyopathy, and myocarditis in patients without a coronary obstruction. The introduction of high-sensitivity assays for cardiac troponins has allowed earlier diagnosis of acute MI in many patients.

But the assays also have caused "considerable confusion among treating physicians" because minor elevations in cardiac troponins can be seen in some patients who do not have a coronary obstruction but have tachyarrhythmia, hypertensive urgency, or heart failure, said Dr. Haaf of University Hospital Basel (Switzerland).

He and his associates analyzed data on the first 887 patients who presented to emergency departments with acute chest pain in the APACE (Advantageous Predictors of Acute Coronary Syndrome Evaluation) study. The ongoing, multicenter study has enrolled close to 2,000 patients so far, obtaining a meticulous patient history, ECG analysis, and measures of novel cardiac biomarkers from each. High-sensitivity cardiac troponin T (hs-cTnT) was measured at presentation and serially thereafter in a blinded fashion, and final diagnosis was adjudicated by two independent cardiologists.

They found that the initial hs-cTnT value and the absolute change in hs-cTnT value within the first hour helped differentiate MI from cardiac but noncoronary disease but that the relative change in hs-cTnT was less discriminatory. In a receiver operating characteristic analysis, using both the initial hs-cTnT and absolute change in the first hour provided an area under the curve of 0.94.

"This is all statistics. What we tried to do is translate these statistics into more clinically applicable terms," Dr. Haaf said.

Analyzing data on 127 patients with acute MI and 125 with cardiac, noncoronary disease, they found that in the 233 patients with ST-segment elevation on ECG, 98% of patients who had an MI had either presentation values for hs-cTnT above 0.028 mcg/L or an absolute change in hs-cTnT of at least 0.005 mcg/L in the first hour.

Changes in hs-cTnT after the first hour did not add much helpful information, he added.

This three-step algorithm – ST elevation, hs-cTnT value at presentation, and absolute change in hs-cTnT in the first hour – provided a positive predictive value of 79% and a "relatively high" negative predictive value of 98% in differentiating acute MI from cardiac, noncoronary disease, Dr. Haaf said.

The study was funded by the Swiss National Science Foundation, the Swiss Heart Foundation, Abbott, Roche, Nanosphere, Siemens, and University Hospital.

No disclosure information was reported.

PARIS – A new algorithm incorporating high-sensitivity cardiac troponin T values in patients with ST-segment elevation seems to differentiate between MI and cardiac but noncoronary disease in patients with acute chest pain.

The algorithm could help triage patients in the first hour of presentation so that those who need coronary angiographies get them quickly and unnecessary angiographies are minimized, Dr. Philip Haaf said in a press briefing at the annual congress of the European Society of Cardiology.

Troponins are increased in cardiovascular disorders including tachyarrhythmia, heart failure, hypertensive urgency or emergency, Takotsubo cardiomyopathy, and myocarditis in patients without a coronary obstruction. The introduction of high-sensitivity assays for cardiac troponins has allowed earlier diagnosis of acute MI in many patients.

But the assays also have caused "considerable confusion among treating physicians" because minor elevations in cardiac troponins can be seen in some patients who do not have a coronary obstruction but have tachyarrhythmia, hypertensive urgency, or heart failure, said Dr. Haaf of University Hospital Basel (Switzerland).

He and his associates analyzed data on the first 887 patients who presented to emergency departments with acute chest pain in the APACE (Advantageous Predictors of Acute Coronary Syndrome Evaluation) study. The ongoing, multicenter study has enrolled close to 2,000 patients so far, obtaining a meticulous patient history, ECG analysis, and measures of novel cardiac biomarkers from each. High-sensitivity cardiac troponin T (hs-cTnT) was measured at presentation and serially thereafter in a blinded fashion, and final diagnosis was adjudicated by two independent cardiologists.

They found that the initial hs-cTnT value and the absolute change in hs-cTnT value within the first hour helped differentiate MI from cardiac but noncoronary disease but that the relative change in hs-cTnT was less discriminatory. In a receiver operating characteristic analysis, using both the initial hs-cTnT and absolute change in the first hour provided an area under the curve of 0.94.

"This is all statistics. What we tried to do is translate these statistics into more clinically applicable terms," Dr. Haaf said.

Analyzing data on 127 patients with acute MI and 125 with cardiac, noncoronary disease, they found that in the 233 patients with ST-segment elevation on ECG, 98% of patients who had an MI had either presentation values for hs-cTnT above 0.028 mcg/L or an absolute change in hs-cTnT of at least 0.005 mcg/L in the first hour.

Changes in hs-cTnT after the first hour did not add much helpful information, he added.

This three-step algorithm – ST elevation, hs-cTnT value at presentation, and absolute change in hs-cTnT in the first hour – provided a positive predictive value of 79% and a "relatively high" negative predictive value of 98% in differentiating acute MI from cardiac, noncoronary disease, Dr. Haaf said.

The study was funded by the Swiss National Science Foundation, the Swiss Heart Foundation, Abbott, Roche, Nanosphere, Siemens, and University Hospital.

No disclosure information was reported.

PARIS – A new algorithm incorporating high-sensitivity cardiac troponin T values in patients with ST-segment elevation seems to differentiate between MI and cardiac but noncoronary disease in patients with acute chest pain.

The algorithm could help triage patients in the first hour of presentation so that those who need coronary angiographies get them quickly and unnecessary angiographies are minimized, Dr. Philip Haaf said in a press briefing at the annual congress of the European Society of Cardiology.

Troponins are increased in cardiovascular disorders including tachyarrhythmia, heart failure, hypertensive urgency or emergency, Takotsubo cardiomyopathy, and myocarditis in patients without a coronary obstruction. The introduction of high-sensitivity assays for cardiac troponins has allowed earlier diagnosis of acute MI in many patients.

But the assays also have caused "considerable confusion among treating physicians" because minor elevations in cardiac troponins can be seen in some patients who do not have a coronary obstruction but have tachyarrhythmia, hypertensive urgency, or heart failure, said Dr. Haaf of University Hospital Basel (Switzerland).

He and his associates analyzed data on the first 887 patients who presented to emergency departments with acute chest pain in the APACE (Advantageous Predictors of Acute Coronary Syndrome Evaluation) study. The ongoing, multicenter study has enrolled close to 2,000 patients so far, obtaining a meticulous patient history, ECG analysis, and measures of novel cardiac biomarkers from each. High-sensitivity cardiac troponin T (hs-cTnT) was measured at presentation and serially thereafter in a blinded fashion, and final diagnosis was adjudicated by two independent cardiologists.

They found that the initial hs-cTnT value and the absolute change in hs-cTnT value within the first hour helped differentiate MI from cardiac but noncoronary disease but that the relative change in hs-cTnT was less discriminatory. In a receiver operating characteristic analysis, using both the initial hs-cTnT and absolute change in the first hour provided an area under the curve of 0.94.

"This is all statistics. What we tried to do is translate these statistics into more clinically applicable terms," Dr. Haaf said.

Analyzing data on 127 patients with acute MI and 125 with cardiac, noncoronary disease, they found that in the 233 patients with ST-segment elevation on ECG, 98% of patients who had an MI had either presentation values for hs-cTnT above 0.028 mcg/L or an absolute change in hs-cTnT of at least 0.005 mcg/L in the first hour.

Changes in hs-cTnT after the first hour did not add much helpful information, he added.

This three-step algorithm – ST elevation, hs-cTnT value at presentation, and absolute change in hs-cTnT in the first hour – provided a positive predictive value of 79% and a "relatively high" negative predictive value of 98% in differentiating acute MI from cardiac, noncoronary disease, Dr. Haaf said.

The study was funded by the Swiss National Science Foundation, the Swiss Heart Foundation, Abbott, Roche, Nanosphere, Siemens, and University Hospital.

No disclosure information was reported.

PARIS – Hemodynamic values were sustained up to 3 years after CoreValve transcatheter aortic valve implantation among 393 patients with severe symptomatic aortic stenosis.

Importantly, there were no signs of unexpected early degeneration of the CoreValve prosthesis, lead author Dr. Anke Opitz reported at the annual congress of the European Society of Cardiology.

One of the fundamental questions facing transcatheter aortic valve implantation (TAVI) is whether the durability of transcatheter aortic valves is comparable to that of conventional biological aortic valves, which typically start degenerating at about 10-15 years.

"We expect that the duration will be as long as the conventional biological aortic valves, but this is a completely new style of valve," Dr. Opitz said in an interview. "It’s very different from the conventional valves because you have to crimp these valves [on to the catheter] and sometimes you do post dilation, so there’s a lot more stress on the valves than on the conventional ones."

The CoreValve (Medtronic) and Edwards Sapien (Edwards Lifesciences) transcatheter valves are limited to investigational use in the United States but have been available in Europe since 2007. U.S. approval of the Edwards Sapien valve is expected, however, following a July 20, 2011 U.S. Food and Drug Administration advisory panel vote in favor of the valve for treatment of certain inoperable patients.

Dr. Opitz reported on 393 consecutive patients implanted from June 2007 to June 2011 at the German Heart Center in Munich with the CoreValve device, which consists of a self-expandable nitinol stent with a porcine pericardium valve. Femoral access was possible in 87% of patients; 63% of patients were implanted with a 29-mm prosthesis and 37% with a 26-mm prosthesis.

The patients’ mean age was 80 years, mean EuroSCORE was 19.1%, and mean Society of Thoracic Surgeons risk score was 5.8%.

Transthoracic echocardiography revealed that the effective orifice area increased significantly, from 0.7 cm² at baseline to 1.55 cm² after TAVI, and remained unchanged through 36 months at 1.57 cm² in 20 evaluable patients, Dr. Opitz reported.

The peak aortic valve gradient decreased significantly after TAVI (78 mm Hg vs. 21 mm Hg), as did the mean aortic valve gradient. Both gradients remained low through the 36 months. Severity of stenosis rises with the gradients.

Septal wall thickness also significantly decreased from 14.9 mm preoperatively to 13.1 mm at 36 months.

Left ventricular end diastolic diameter remained unchanged from baseline at 12-, 24-, and 36-month follow-ups. The percentage of patients with a left ventricular ejection fraction less than 35% decreased significantly, from 19% at baseline to 4% at 12 months, 6% at 24 months, and 7% at 36 months, Dr. Opitz said.

Paravalvular aortic valve regurgitation occurred in 64% of patients after TAVI but was trivial or mild in 65%, mild to moderate in 20%, and moderate in 15%, she noted.

Dr. Opitz reported no conflicts of interest.

PARIS – Hemodynamic values were sustained up to 3 years after CoreValve transcatheter aortic valve implantation among 393 patients with severe symptomatic aortic stenosis.

Importantly, there were no signs of unexpected early degeneration of the CoreValve prosthesis, lead author Dr. Anke Opitz reported at the annual congress of the European Society of Cardiology.

One of the fundamental questions facing transcatheter aortic valve implantation (TAVI) is whether the durability of transcatheter aortic valves is comparable to that of conventional biological aortic valves, which typically start degenerating at about 10-15 years.

"We expect that the duration will be as long as the conventional biological aortic valves, but this is a completely new style of valve," Dr. Opitz said in an interview. "It’s very different from the conventional valves because you have to crimp these valves [on to the catheter] and sometimes you do post dilation, so there’s a lot more stress on the valves than on the conventional ones."

The CoreValve (Medtronic) and Edwards Sapien (Edwards Lifesciences) transcatheter valves are limited to investigational use in the United States but have been available in Europe since 2007. U.S. approval of the Edwards Sapien valve is expected, however, following a July 20, 2011 U.S. Food and Drug Administration advisory panel vote in favor of the valve for treatment of certain inoperable patients.

Dr. Opitz reported on 393 consecutive patients implanted from June 2007 to June 2011 at the German Heart Center in Munich with the CoreValve device, which consists of a self-expandable nitinol stent with a porcine pericardium valve. Femoral access was possible in 87% of patients; 63% of patients were implanted with a 29-mm prosthesis and 37% with a 26-mm prosthesis.

The patients’ mean age was 80 years, mean EuroSCORE was 19.1%, and mean Society of Thoracic Surgeons risk score was 5.8%.

Transthoracic echocardiography revealed that the effective orifice area increased significantly, from 0.7 cm² at baseline to 1.55 cm² after TAVI, and remained unchanged through 36 months at 1.57 cm² in 20 evaluable patients, Dr. Opitz reported.

The peak aortic valve gradient decreased significantly after TAVI (78 mm Hg vs. 21 mm Hg), as did the mean aortic valve gradient. Both gradients remained low through the 36 months. Severity of stenosis rises with the gradients.

Septal wall thickness also significantly decreased from 14.9 mm preoperatively to 13.1 mm at 36 months.

Left ventricular end diastolic diameter remained unchanged from baseline at 12-, 24-, and 36-month follow-ups. The percentage of patients with a left ventricular ejection fraction less than 35% decreased significantly, from 19% at baseline to 4% at 12 months, 6% at 24 months, and 7% at 36 months, Dr. Opitz said.

Paravalvular aortic valve regurgitation occurred in 64% of patients after TAVI but was trivial or mild in 65%, mild to moderate in 20%, and moderate in 15%, she noted.

Dr. Opitz reported no conflicts of interest.

PARIS – Hemodynamic values were sustained up to 3 years after CoreValve transcatheter aortic valve implantation among 393 patients with severe symptomatic aortic stenosis.

Importantly, there were no signs of unexpected early degeneration of the CoreValve prosthesis, lead author Dr. Anke Opitz reported at the annual congress of the European Society of Cardiology.

One of the fundamental questions facing transcatheter aortic valve implantation (TAVI) is whether the durability of transcatheter aortic valves is comparable to that of conventional biological aortic valves, which typically start degenerating at about 10-15 years.

"We expect that the duration will be as long as the conventional biological aortic valves, but this is a completely new style of valve," Dr. Opitz said in an interview. "It’s very different from the conventional valves because you have to crimp these valves [on to the catheter] and sometimes you do post dilation, so there’s a lot more stress on the valves than on the conventional ones."

The CoreValve (Medtronic) and Edwards Sapien (Edwards Lifesciences) transcatheter valves are limited to investigational use in the United States but have been available in Europe since 2007. U.S. approval of the Edwards Sapien valve is expected, however, following a July 20, 2011 U.S. Food and Drug Administration advisory panel vote in favor of the valve for treatment of certain inoperable patients.

Dr. Opitz reported on 393 consecutive patients implanted from June 2007 to June 2011 at the German Heart Center in Munich with the CoreValve device, which consists of a self-expandable nitinol stent with a porcine pericardium valve. Femoral access was possible in 87% of patients; 63% of patients were implanted with a 29-mm prosthesis and 37% with a 26-mm prosthesis.

The patients’ mean age was 80 years, mean EuroSCORE was 19.1%, and mean Society of Thoracic Surgeons risk score was 5.8%.

Transthoracic echocardiography revealed that the effective orifice area increased significantly, from 0.7 cm² at baseline to 1.55 cm² after TAVI, and remained unchanged through 36 months at 1.57 cm² in 20 evaluable patients, Dr. Opitz reported.

The peak aortic valve gradient decreased significantly after TAVI (78 mm Hg vs. 21 mm Hg), as did the mean aortic valve gradient. Both gradients remained low through the 36 months. Severity of stenosis rises with the gradients.

Septal wall thickness also significantly decreased from 14.9 mm preoperatively to 13.1 mm at 36 months.

Left ventricular end diastolic diameter remained unchanged from baseline at 12-, 24-, and 36-month follow-ups. The percentage of patients with a left ventricular ejection fraction less than 35% decreased significantly, from 19% at baseline to 4% at 12 months, 6% at 24 months, and 7% at 36 months, Dr. Opitz said.

Paravalvular aortic valve regurgitation occurred in 64% of patients after TAVI but was trivial or mild in 65%, mild to moderate in 20%, and moderate in 15%, she noted.

Dr. Opitz reported no conflicts of interest.

PARIS – In inoperable patients with severe aortic stenosis, their EuroSCORE – a predicted operative mortality from cardiac surgery – consistently predicted outcomes from transcatheter aortic valve implantation in a prospective, single-center study.

Among 177 consecutive patients declined for surgery, the procedural success rate was 100% in patients with a EuroSCORE of less than 20% and 95.7% in those with a EuroSCORE of more than 20%.

Moreover, there were no deaths at 30 days in the low-risk group, but mortality was 11.1% in the high-risk group. This result was maintained at 1 year (5% vs. 25%), and both differences were highly significant, Dr. Matthieu Godin reported at the annual congress of the European Society of Cardiology.

"This may be the first step towards a broader assessment of percutaneous techniques in populations at lower surgical risk, but without forgetting that surgery is currently the ... standard," he said.

Transcatheter aortic valve implantation (TAVI) is not commercially avaliable in the United States. In Europe, however, TAVI is considered a less invasive therapeutic option for severe aortic stenosis among nonsurgical and high–surgical-risk patients, as defined by a logistic EuroSCORE (European System for Cardiac Operative Risk) of more than 20% or a Society of Thoracic Surgeons risk score of more than 10%.

TAVI is frequently performed, however, in patients with low to intermediate logistic EuroSCOREs and contraindications to conventional valve replacement due to comorbidities not included in the surgical risk models, said Dr. Godin of Rouen (France) University Hospital–Charles Nicolle Hospital, where the first TAVI was performed in 2002 by coinvestigator Dr. Alain Cribier (Circulation 2002;106:3006-8).

In an effort to address this evolution and an eager marketplace, the American College of Cardiology and Society of Thoracic Surgeons released an expert consensus document that explores key components that will be necessary for successful integration of transcatheter valve therapy into clinical practice (J. Am. Coll. Cardiol. 2011;58:445-55). While praising the "transformational technology," the societies cite limited evidence from only one randomized trial in aortic stenosis (PARTNER) and one in mitral insufficiency (EVEREST II) in stating that "adoption of these techniques to populations beyond those studied in these randomized trials, therefore, is not appropriate at the current time."

Dr. Godin stressed that his results should not be interpreted to suggest that the indication for TAVI should be expanded to low-risk surgical candidates and said that this would require a large-scale trial like PARTNER and long-term follow-up on the durability of the prostheses.

The Placement of Aortic Transcatheter Valves (PARTNER) trial enrolled two distinct cohorts. Cohort A included 699 patients (median age 84 years) who were candidates for conventional surgery but were at high surgical risk based on an STS score of at least 10% or on coexisting conditions that would be associated with at least a 15% predicted risk of death by 30 days after surgery. Cohort B included 358 patients (median age 83 years) who were deemed unsuitable for conventional surgery because of coexisting conditions that would be associated with at least a 50% predicted probability of death by 30 days after surgery or a serious irreversible complication (N. Engl. J. Med. 2010;363:1597-607).

Dr. Godin’s analysis included 177 patients who presented between 2006 and 2011 with degenerative aortic stenosis and were implanted with the Edwards Sapien valve up to October 2009 and the Edwards Sapien-XT prosthesis thereafter. A transfemoral approach was used in 72% and a transapical approach in 28%.

In all, 60 patients had a EuroSCORE of less than 20% (mean 12%) and 117 had a EuroSCORE of at least 20% (mean 32%). Their mean ages were 80 years and 84 years, respectively.

Contraindications to conventional surgery in the low-risk group included porcelain aorta in 15%, chest irradiation in 20%, and chest deformity in 8.3%.

The low- and high-risk groups had similar rates of major stroke (1.7% and 0.9%, respectively), major vascular complications (5% and 6%), and definitive pacemaker implantation (5% and 6%), Dr. Godin reported.

The low-risk group had significantly less life-threatening bleeding (7% vs. 21%) and significantly shorter mean ICU stays (2 days vs. 3 days) and mean hospital stays (9 days vs. 11 days).

Dr. Godin reported no conflicts. Dr. Cribier is a consultant for Edwards Lifesciences, and two additional coauthors are proctors for the company.

PARIS – In inoperable patients with severe aortic stenosis, their EuroSCORE – a predicted operative mortality from cardiac surgery – consistently predicted outcomes from transcatheter aortic valve implantation in a prospective, single-center study.

Among 177 consecutive patients declined for surgery, the procedural success rate was 100% in patients with a EuroSCORE of less than 20% and 95.7% in those with a EuroSCORE of more than 20%.

Moreover, there were no deaths at 30 days in the low-risk group, but mortality was 11.1% in the high-risk group. This result was maintained at 1 year (5% vs. 25%), and both differences were highly significant, Dr. Matthieu Godin reported at the annual congress of the European Society of Cardiology.

"This may be the first step towards a broader assessment of percutaneous techniques in populations at lower surgical risk, but without forgetting that surgery is currently the ... standard," he said.

Transcatheter aortic valve implantation (TAVI) is not commercially avaliable in the United States. In Europe, however, TAVI is considered a less invasive therapeutic option for severe aortic stenosis among nonsurgical and high–surgical-risk patients, as defined by a logistic EuroSCORE (European System for Cardiac Operative Risk) of more than 20% or a Society of Thoracic Surgeons risk score of more than 10%.

TAVI is frequently performed, however, in patients with low to intermediate logistic EuroSCOREs and contraindications to conventional valve replacement due to comorbidities not included in the surgical risk models, said Dr. Godin of Rouen (France) University Hospital–Charles Nicolle Hospital, where the first TAVI was performed in 2002 by coinvestigator Dr. Alain Cribier (Circulation 2002;106:3006-8).

In an effort to address this evolution and an eager marketplace, the American College of Cardiology and Society of Thoracic Surgeons released an expert consensus document that explores key components that will be necessary for successful integration of transcatheter valve therapy into clinical practice (J. Am. Coll. Cardiol. 2011;58:445-55). While praising the "transformational technology," the societies cite limited evidence from only one randomized trial in aortic stenosis (PARTNER) and one in mitral insufficiency (EVEREST II) in stating that "adoption of these techniques to populations beyond those studied in these randomized trials, therefore, is not appropriate at the current time."

Dr. Godin stressed that his results should not be interpreted to suggest that the indication for TAVI should be expanded to low-risk surgical candidates and said that this would require a large-scale trial like PARTNER and long-term follow-up on the durability of the prostheses.

The Placement of Aortic Transcatheter Valves (PARTNER) trial enrolled two distinct cohorts. Cohort A included 699 patients (median age 84 years) who were candidates for conventional surgery but were at high surgical risk based on an STS score of at least 10% or on coexisting conditions that would be associated with at least a 15% predicted risk of death by 30 days after surgery. Cohort B included 358 patients (median age 83 years) who were deemed unsuitable for conventional surgery because of coexisting conditions that would be associated with at least a 50% predicted probability of death by 30 days after surgery or a serious irreversible complication (N. Engl. J. Med. 2010;363:1597-607).

Dr. Godin’s analysis included 177 patients who presented between 2006 and 2011 with degenerative aortic stenosis and were implanted with the Edwards Sapien valve up to October 2009 and the Edwards Sapien-XT prosthesis thereafter. A transfemoral approach was used in 72% and a transapical approach in 28%.

In all, 60 patients had a EuroSCORE of less than 20% (mean 12%) and 117 had a EuroSCORE of at least 20% (mean 32%). Their mean ages were 80 years and 84 years, respectively.

Contraindications to conventional surgery in the low-risk group included porcelain aorta in 15%, chest irradiation in 20%, and chest deformity in 8.3%.

The low- and high-risk groups had similar rates of major stroke (1.7% and 0.9%, respectively), major vascular complications (5% and 6%), and definitive pacemaker implantation (5% and 6%), Dr. Godin reported.

The low-risk group had significantly less life-threatening bleeding (7% vs. 21%) and significantly shorter mean ICU stays (2 days vs. 3 days) and mean hospital stays (9 days vs. 11 days).

Dr. Godin reported no conflicts. Dr. Cribier is a consultant for Edwards Lifesciences, and two additional coauthors are proctors for the company.

PARIS – In inoperable patients with severe aortic stenosis, their EuroSCORE – a predicted operative mortality from cardiac surgery – consistently predicted outcomes from transcatheter aortic valve implantation in a prospective, single-center study.

Among 177 consecutive patients declined for surgery, the procedural success rate was 100% in patients with a EuroSCORE of less than 20% and 95.7% in those with a EuroSCORE of more than 20%.

Moreover, there were no deaths at 30 days in the low-risk group, but mortality was 11.1% in the high-risk group. This result was maintained at 1 year (5% vs. 25%), and both differences were highly significant, Dr. Matthieu Godin reported at the annual congress of the European Society of Cardiology.

"This may be the first step towards a broader assessment of percutaneous techniques in populations at lower surgical risk, but without forgetting that surgery is currently the ... standard," he said.

Transcatheter aortic valve implantation (TAVI) is not commercially avaliable in the United States. In Europe, however, TAVI is considered a less invasive therapeutic option for severe aortic stenosis among nonsurgical and high–surgical-risk patients, as defined by a logistic EuroSCORE (European System for Cardiac Operative Risk) of more than 20% or a Society of Thoracic Surgeons risk score of more than 10%.

TAVI is frequently performed, however, in patients with low to intermediate logistic EuroSCOREs and contraindications to conventional valve replacement due to comorbidities not included in the surgical risk models, said Dr. Godin of Rouen (France) University Hospital–Charles Nicolle Hospital, where the first TAVI was performed in 2002 by coinvestigator Dr. Alain Cribier (Circulation 2002;106:3006-8).

In an effort to address this evolution and an eager marketplace, the American College of Cardiology and Society of Thoracic Surgeons released an expert consensus document that explores key components that will be necessary for successful integration of transcatheter valve therapy into clinical practice (J. Am. Coll. Cardiol. 2011;58:445-55). While praising the "transformational technology," the societies cite limited evidence from only one randomized trial in aortic stenosis (PARTNER) and one in mitral insufficiency (EVEREST II) in stating that "adoption of these techniques to populations beyond those studied in these randomized trials, therefore, is not appropriate at the current time."

Dr. Godin stressed that his results should not be interpreted to suggest that the indication for TAVI should be expanded to low-risk surgical candidates and said that this would require a large-scale trial like PARTNER and long-term follow-up on the durability of the prostheses.

The Placement of Aortic Transcatheter Valves (PARTNER) trial enrolled two distinct cohorts. Cohort A included 699 patients (median age 84 years) who were candidates for conventional surgery but were at high surgical risk based on an STS score of at least 10% or on coexisting conditions that would be associated with at least a 15% predicted risk of death by 30 days after surgery. Cohort B included 358 patients (median age 83 years) who were deemed unsuitable for conventional surgery because of coexisting conditions that would be associated with at least a 50% predicted probability of death by 30 days after surgery or a serious irreversible complication (N. Engl. J. Med. 2010;363:1597-607).

Dr. Godin’s analysis included 177 patients who presented between 2006 and 2011 with degenerative aortic stenosis and were implanted with the Edwards Sapien valve up to October 2009 and the Edwards Sapien-XT prosthesis thereafter. A transfemoral approach was used in 72% and a transapical approach in 28%.

In all, 60 patients had a EuroSCORE of less than 20% (mean 12%) and 117 had a EuroSCORE of at least 20% (mean 32%). Their mean ages were 80 years and 84 years, respectively.

Contraindications to conventional surgery in the low-risk group included porcelain aorta in 15%, chest irradiation in 20%, and chest deformity in 8.3%.

The low- and high-risk groups had similar rates of major stroke (1.7% and 0.9%, respectively), major vascular complications (5% and 6%), and definitive pacemaker implantation (5% and 6%), Dr. Godin reported.

The low-risk group had significantly less life-threatening bleeding (7% vs. 21%) and significantly shorter mean ICU stays (2 days vs. 3 days) and mean hospital stays (9 days vs. 11 days).

Dr. Godin reported no conflicts. Dr. Cribier is a consultant for Edwards Lifesciences, and two additional coauthors are proctors for the company.

PARIS – Patients with severe vitamin D deficiency who underwent vascular surgery faced a significant, 56% increased risk for developing a cardiovascular event during the 30 days following surgery compared with patients who had a sufficient vitamin D level, in a review of 269 patients treated at a single Dutch center.

The study findings did not address whether patients who were vitamin D deficient and then received a vitamin D supplement had a reduced number of postsurgical events, Dr. Koen M. van de Luijtgaarden and his associates from Erasmus University Medical Center in Rotterdam, The Netherlands reported in a poster at the meeting.

The study also documented the frequency of vitamin D deficiency or insufficiency in patients scheduled for vascular surgery. Of the 269 patients included in the review who underwent vascular surgery during 2008-2010 at Erasmus Medical Center, 78 (29%) had a sufficient plasma level of vitamin D at baseline, defined as a 25-hydroxyvitamin D level of greater than 75 nmol/L. In all 38 of the patients (14%) had severe vitamin D deficiency at baseline, defined as 25 nmol/L or less. A total of 76 (28%) had moderate deficiency, defined as more than 25 nmol/L to 50 nmol/L, and 77 (29%) had vitamin D insufficiency, defined as more than 50 nmol/L to 75 nmol/L.

About two-thirds of the surgery patients were men, and the average age of all patients in the review was 66.

The primary endpoint of the study was the rate of cardiovascular events during the first 30 days after surgery, a composite tally that included the rates of cardiovascular deaths, nonfatal myocardial damage, or stroke. The incidence of these events was 38% in the severely deficient patients, 24% in patients with moderate deficiency, 32% in patients with vitamin D insufficiency, and 13% in those with a sufficient level of the vitamin.

In a multivariate analysis that controlled for baseline differences in demographics, medical history, and medications, patients in the severely deficient group had a statistically significant, 56% increased incidence of cardiovascular events, compared with patients with a sufficient vitamin D level. Patients with moderate deficiency or insufficiency both showed trends toward more events compared with the sufficient group, but in neither case was the difference statistically significant.

The findings are consistent with prior reports that vitamin D deficiency links with an increased risk for atherosclerosis and cardiovascular events, said Dr. van de Luijtgaarden, a researcher in the department of vascular surgery at Erasmus, and his associates.

Dr. van de Luijtgaarden said that he and his associates had no disclosures.

PARIS – Patients with severe vitamin D deficiency who underwent vascular surgery faced a significant, 56% increased risk for developing a cardiovascular event during the 30 days following surgery compared with patients who had a sufficient vitamin D level, in a review of 269 patients treated at a single Dutch center.

The study findings did not address whether patients who were vitamin D deficient and then received a vitamin D supplement had a reduced number of postsurgical events, Dr. Koen M. van de Luijtgaarden and his associates from Erasmus University Medical Center in Rotterdam, The Netherlands reported in a poster at the meeting.

The study also documented the frequency of vitamin D deficiency or insufficiency in patients scheduled for vascular surgery. Of the 269 patients included in the review who underwent vascular surgery during 2008-2010 at Erasmus Medical Center, 78 (29%) had a sufficient plasma level of vitamin D at baseline, defined as a 25-hydroxyvitamin D level of greater than 75 nmol/L. In all 38 of the patients (14%) had severe vitamin D deficiency at baseline, defined as 25 nmol/L or less. A total of 76 (28%) had moderate deficiency, defined as more than 25 nmol/L to 50 nmol/L, and 77 (29%) had vitamin D insufficiency, defined as more than 50 nmol/L to 75 nmol/L.

About two-thirds of the surgery patients were men, and the average age of all patients in the review was 66.

The primary endpoint of the study was the rate of cardiovascular events during the first 30 days after surgery, a composite tally that included the rates of cardiovascular deaths, nonfatal myocardial damage, or stroke. The incidence of these events was 38% in the severely deficient patients, 24% in patients with moderate deficiency, 32% in patients with vitamin D insufficiency, and 13% in those with a sufficient level of the vitamin.

In a multivariate analysis that controlled for baseline differences in demographics, medical history, and medications, patients in the severely deficient group had a statistically significant, 56% increased incidence of cardiovascular events, compared with patients with a sufficient vitamin D level. Patients with moderate deficiency or insufficiency both showed trends toward more events compared with the sufficient group, but in neither case was the difference statistically significant.

The findings are consistent with prior reports that vitamin D deficiency links with an increased risk for atherosclerosis and cardiovascular events, said Dr. van de Luijtgaarden, a researcher in the department of vascular surgery at Erasmus, and his associates.

Dr. van de Luijtgaarden said that he and his associates had no disclosures.

PARIS – Patients with severe vitamin D deficiency who underwent vascular surgery faced a significant, 56% increased risk for developing a cardiovascular event during the 30 days following surgery compared with patients who had a sufficient vitamin D level, in a review of 269 patients treated at a single Dutch center.

The study findings did not address whether patients who were vitamin D deficient and then received a vitamin D supplement had a reduced number of postsurgical events, Dr. Koen M. van de Luijtgaarden and his associates from Erasmus University Medical Center in Rotterdam, The Netherlands reported in a poster at the meeting.

The study also documented the frequency of vitamin D deficiency or insufficiency in patients scheduled for vascular surgery. Of the 269 patients included in the review who underwent vascular surgery during 2008-2010 at Erasmus Medical Center, 78 (29%) had a sufficient plasma level of vitamin D at baseline, defined as a 25-hydroxyvitamin D level of greater than 75 nmol/L. In all 38 of the patients (14%) had severe vitamin D deficiency at baseline, defined as 25 nmol/L or less. A total of 76 (28%) had moderate deficiency, defined as more than 25 nmol/L to 50 nmol/L, and 77 (29%) had vitamin D insufficiency, defined as more than 50 nmol/L to 75 nmol/L.

About two-thirds of the surgery patients were men, and the average age of all patients in the review was 66.

The primary endpoint of the study was the rate of cardiovascular events during the first 30 days after surgery, a composite tally that included the rates of cardiovascular deaths, nonfatal myocardial damage, or stroke. The incidence of these events was 38% in the severely deficient patients, 24% in patients with moderate deficiency, 32% in patients with vitamin D insufficiency, and 13% in those with a sufficient level of the vitamin.

In a multivariate analysis that controlled for baseline differences in demographics, medical history, and medications, patients in the severely deficient group had a statistically significant, 56% increased incidence of cardiovascular events, compared with patients with a sufficient vitamin D level. Patients with moderate deficiency or insufficiency both showed trends toward more events compared with the sufficient group, but in neither case was the difference statistically significant.

The findings are consistent with prior reports that vitamin D deficiency links with an increased risk for atherosclerosis and cardiovascular events, said Dr. van de Luijtgaarden, a researcher in the department of vascular surgery at Erasmus, and his associates.

Dr. van de Luijtgaarden said that he and his associates had no disclosures.