Caroline Helwick

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

[Want more news from the ACC's annual scientific session? Check out our complete coverage of the meeting.]

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

[Want more news from the ACC's annual scientific session? Check out our complete coverage of the meeting.]

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

[Want more news from the ACC's annual scientific session? Check out our complete coverage of the meeting.]

NEW ORLEANS – Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a the April 4 late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

"PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events" in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease).

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr.Park of Asan Medical Center, Seoul, South Korea.

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke – which the investigators considered a marker of safety – was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization – 9% with PCI and 4.2% with CABG.

Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]).

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison.

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ significantly in this clinical setting, are in agreement with the results of the SYNTAX substudy involving patients with left main coronary artery stenosis," Dr. Park said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72).

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had a 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, according to Dr. Park.

At a press briefing discussion of the results, Dr. Spencer King, professor of medicine emeritus at Emory University, Atlanta, remarked that "Certainly, (the PRECOMBAT) results are very consistent with the SYNTAX results and add more evidence to the benefit of intervention in left main cases."

NEW ORLEANS – Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a the April 4 late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

"PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events" in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease).

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr.Park of Asan Medical Center, Seoul, South Korea.

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke – which the investigators considered a marker of safety – was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization – 9% with PCI and 4.2% with CABG.

Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]).

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison.

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ significantly in this clinical setting, are in agreement with the results of the SYNTAX substudy involving patients with left main coronary artery stenosis," Dr. Park said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72).

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had a 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, according to Dr. Park.

At a press briefing discussion of the results, Dr. Spencer King, professor of medicine emeritus at Emory University, Atlanta, remarked that "Certainly, (the PRECOMBAT) results are very consistent with the SYNTAX results and add more evidence to the benefit of intervention in left main cases."

NEW ORLEANS – Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a the April 4 late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

"PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events" in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease).

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr.Park of Asan Medical Center, Seoul, South Korea.

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke – which the investigators considered a marker of safety – was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization – 9% with PCI and 4.2% with CABG.

Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]).

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison.

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ significantly in this clinical setting, are in agreement with the results of the SYNTAX substudy involving patients with left main coronary artery stenosis," Dr. Park said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72).

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had a 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, according to Dr. Park.

At a press briefing discussion of the results, Dr. Spencer King, professor of medicine emeritus at Emory University, Atlanta, remarked that "Certainly, (the PRECOMBAT) results are very consistent with the SYNTAX results and add more evidence to the benefit of intervention in left main cases."

NEW ORLEANS – Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a the April 4 late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

"PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events" in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease).

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr.Park of Asan Medical Center, Seoul, South Korea.

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke – which the investigators considered a marker of safety – was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization – 9% with PCI and 4.2% with CABG.

Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]).

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison.

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ significantly in this clinical setting, are in agreement with the results of the SYNTAX substudy involving patients with left main coronary artery stenosis," Dr. Park said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72).

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had a 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, according to Dr. Park.

At a press briefing discussion of the results, Dr. Spencer King, professor of medicine emeritus at Emory University, Atlanta, remarked that "Certainly, (the PRECOMBAT) results are very consistent with the SYNTAX results and add more evidence to the benefit of intervention in left main cases."

NEW ORLEANS – Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a the April 4 late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

"PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events" in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease).

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr.Park of Asan Medical Center, Seoul, South Korea.

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke – which the investigators considered a marker of safety – was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization – 9% with PCI and 4.2% with CABG.

Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]).

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison.

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ significantly in this clinical setting, are in agreement with the results of the SYNTAX substudy involving patients with left main coronary artery stenosis," Dr. Park said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72).

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had a 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, according to Dr. Park.

At a press briefing discussion of the results, Dr. Spencer King, professor of medicine emeritus at Emory University, Atlanta, remarked that "Certainly, (the PRECOMBAT) results are very consistent with the SYNTAX results and add more evidence to the benefit of intervention in left main cases."

NEW ORLEANS – Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a the April 4 late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

"PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events" in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease).

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr.Park of Asan Medical Center, Seoul, South Korea.

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke – which the investigators considered a marker of safety – was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization – 9% with PCI and 4.2% with CABG.

Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]).

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison.

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ significantly in this clinical setting, are in agreement with the results of the SYNTAX substudy involving patients with left main coronary artery stenosis," Dr. Park said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72).

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had a 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, according to Dr. Park.

At a press briefing discussion of the results, Dr. Spencer King, professor of medicine emeritus at Emory University, Atlanta, remarked that "Certainly, (the PRECOMBAT) results are very consistent with the SYNTAX results and add more evidence to the benefit of intervention in left main cases."

NEW ORLEANS – Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a the April 4 late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

"PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events" in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease).

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr.Park of Asan Medical Center, Seoul, South Korea.

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke – which the investigators considered a marker of safety – was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization – 9% with PCI and 4.2% with CABG.

Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]).

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison.

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ significantly in this clinical setting, are in agreement with the results of the SYNTAX substudy involving patients with left main coronary artery stenosis," Dr. Park said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72).

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had a 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, according to Dr. Park.

At a press briefing discussion of the results, Dr. Spencer King, professor of medicine emeritus at Emory University, Atlanta, remarked that "Certainly, (the PRECOMBAT) results are very consistent with the SYNTAX results and add more evidence to the benefit of intervention in left main cases."

NEW ORLEANS – Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a the April 4 late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

"PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events" in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease).

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr.Park of Asan Medical Center, Seoul, South Korea.

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke – which the investigators considered a marker of safety – was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization – 9% with PCI and 4.2% with CABG.

Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]).

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison.

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ significantly in this clinical setting, are in agreement with the results of the SYNTAX substudy involving patients with left main coronary artery stenosis," Dr. Park said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72).

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had a 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, according to Dr. Park.

At a press briefing discussion of the results, Dr. Spencer King, professor of medicine emeritus at Emory University, Atlanta, remarked that "Certainly, (the PRECOMBAT) results are very consistent with the SYNTAX results and add more evidence to the benefit of intervention in left main cases."

NEW ORLEANS – Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a the April 4 late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

"PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events" in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease).

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr.Park of Asan Medical Center, Seoul, South Korea.

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke – which the investigators considered a marker of safety – was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization – 9% with PCI and 4.2% with CABG.

Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]).

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison.

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ significantly in this clinical setting, are in agreement with the results of the SYNTAX substudy involving patients with left main coronary artery stenosis," Dr. Park said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72).

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had a 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, according to Dr. Park.

At a press briefing discussion of the results, Dr. Spencer King, professor of medicine emeritus at Emory University, Atlanta, remarked that "Certainly, (the PRECOMBAT) results are very consistent with the SYNTAX results and add more evidence to the benefit of intervention in left main cases."

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS  – In the 10-year follow-up of a study in patients with stable coronary artery disease, the ratio of triglycerides to high-density lipoproteins was highly predictive of major adverse cardiovascular events (MACE).

Dr. Raul D. Santos of the Heart Institute at the University of Sao Paulo Medical School Hospital in Brazil reported the analysis, which was part of the Medical, Angioplasty, or Surgery Study (MASS-II). That study compared the long-term effects of medical treatment, angioplasty, or surgical strategies in patients with stable angina symptoms of multivessel coronary artery disease (CAD) and preserved ventricular function, determining that surgery was the optimal approach in this patient subset (J. Am. Coll. Cardiol. 2004;43:1743-51)

“After 10 years of follow-up of stable CAD patients in MASS-II, the TG/HDL [triglyceride/high-density lipoprotein] ratio was the only lipid parameter independently associated” with major adverse cardiovascular events (MACE), Dr. Santos reported in the poster presentation.

The study randomly assigned 611 patients to coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or medical therapy. Lipid-modifying therapies were equally instituted in all study patient groups. Concentrations of total cholesterol, high-density lipoprotein (HDL), non-HDL cholesterol, and low-density lipoprotein (LDL) cholesterol, as well as LDL/HDL and TG/HDL ratios, were divided according to distribution quartiles. The associations between MACE occurrence and plasma lipids at baseline and at 6 months, as well as other risk factors and randomized CAD treatment, were determined by Cox regression models.

Mean levels of lipids were 150 mg/dL for TG, 37 mg/dL for HDL cholesterol, and 140 mg/dL for LDL cholesterol.

“LDL was not well treated at the time this study began 11 years ago. Only about one third of patients were on statins, and mean levels were about 140 mg/dL,” Dr. Santos said. “Yet, even in these patients with high LDL, the TG/HDL ratio was a marker for later events.”

In the MASS-II patients followed for an average of 11.4 years (range 9-15 years), MACE were observed in 42% of the PCI arm, 59% of the medical therapy arm, and 33% of the CABG arm.

After adjustment for confounders, the investigators found the following factors to be independently associated with MACE: age greater than 65 years, randomization to CABG versus medical therapy, systemic arterial hypertension, and TG/HDL ratio determined at 6 months.

For the TG/HDL ratio, the hazard ratio for the occurrence of MACE, comparing the highest and lowest quartiles of the ratios, was significant at 1.57 (P = .015). Hazard ratios for the third versus first quartiles was 1.38 (P = .098) and for the second versus first quartiles was 0.83 (P = .445). No association was found between MACE and other plasma lipids.

Among patients with a TG/HDL ratio greater than 6, only about 45% of patients were free of MACE at 10 years, compared with greater than 70% for those with a TG/HDL ratio of less than 3. 

“The TG/HDL ratio is a marker of residual risk,” Dr. Santos said. “For clinicians, this means that you treat the LDL, of course, but you need to look at triglycerides and HDL. While the lab doesn’t give you this ratio, it’s very easy to calculate.”

Dr. Gerald S. Berenson of Tulane University School of Medicine, New Orleans, and principal investigator of the Bogalusa Heart Study, viewed the poster with interest. “This is very important information,” he said. “The TG/HDL ratio is so easy to measure. Everyone is looking at particle size, and so forth, but we routinely get these levels, so you just need to look at the ratio. It’s a good measure of insulin resistance as well.”

Dr. Santos has served on the speakers bureaus of Novartis, Merck, Biolab, and Bristol-Myers Squibb. Dr. Berenson had no relevant conflicts of interest.

NEW ORLEANS  – In the 10-year follow-up of a study in patients with stable coronary artery disease, the ratio of triglycerides to high-density lipoproteins was highly predictive of major adverse cardiovascular events (MACE).

Dr. Raul D. Santos of the Heart Institute at the University of Sao Paulo Medical School Hospital in Brazil reported the analysis, which was part of the Medical, Angioplasty, or Surgery Study (MASS-II). That study compared the long-term effects of medical treatment, angioplasty, or surgical strategies in patients with stable angina symptoms of multivessel coronary artery disease (CAD) and preserved ventricular function, determining that surgery was the optimal approach in this patient subset (J. Am. Coll. Cardiol. 2004;43:1743-51)

“After 10 years of follow-up of stable CAD patients in MASS-II, the TG/HDL [triglyceride/high-density lipoprotein] ratio was the only lipid parameter independently associated” with major adverse cardiovascular events (MACE), Dr. Santos reported in the poster presentation.

The study randomly assigned 611 patients to coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or medical therapy. Lipid-modifying therapies were equally instituted in all study patient groups. Concentrations of total cholesterol, high-density lipoprotein (HDL), non-HDL cholesterol, and low-density lipoprotein (LDL) cholesterol, as well as LDL/HDL and TG/HDL ratios, were divided according to distribution quartiles. The associations between MACE occurrence and plasma lipids at baseline and at 6 months, as well as other risk factors and randomized CAD treatment, were determined by Cox regression models.

Mean levels of lipids were 150 mg/dL for TG, 37 mg/dL for HDL cholesterol, and 140 mg/dL for LDL cholesterol.

“LDL was not well treated at the time this study began 11 years ago. Only about one third of patients were on statins, and mean levels were about 140 mg/dL,” Dr. Santos said. “Yet, even in these patients with high LDL, the TG/HDL ratio was a marker for later events.”

In the MASS-II patients followed for an average of 11.4 years (range 9-15 years), MACE were observed in 42% of the PCI arm, 59% of the medical therapy arm, and 33% of the CABG arm.

After adjustment for confounders, the investigators found the following factors to be independently associated with MACE: age greater than 65 years, randomization to CABG versus medical therapy, systemic arterial hypertension, and TG/HDL ratio determined at 6 months.

For the TG/HDL ratio, the hazard ratio for the occurrence of MACE, comparing the highest and lowest quartiles of the ratios, was significant at 1.57 (P = .015). Hazard ratios for the third versus first quartiles was 1.38 (P = .098) and for the second versus first quartiles was 0.83 (P = .445). No association was found between MACE and other plasma lipids.

Among patients with a TG/HDL ratio greater than 6, only about 45% of patients were free of MACE at 10 years, compared with greater than 70% for those with a TG/HDL ratio of less than 3. 

“The TG/HDL ratio is a marker of residual risk,” Dr. Santos said. “For clinicians, this means that you treat the LDL, of course, but you need to look at triglycerides and HDL. While the lab doesn’t give you this ratio, it’s very easy to calculate.”

Dr. Gerald S. Berenson of Tulane University School of Medicine, New Orleans, and principal investigator of the Bogalusa Heart Study, viewed the poster with interest. “This is very important information,” he said. “The TG/HDL ratio is so easy to measure. Everyone is looking at particle size, and so forth, but we routinely get these levels, so you just need to look at the ratio. It’s a good measure of insulin resistance as well.”

Dr. Santos has served on the speakers bureaus of Novartis, Merck, Biolab, and Bristol-Myers Squibb. Dr. Berenson had no relevant conflicts of interest.

NEW ORLEANS  – In the 10-year follow-up of a study in patients with stable coronary artery disease, the ratio of triglycerides to high-density lipoproteins was highly predictive of major adverse cardiovascular events (MACE).

Dr. Raul D. Santos of the Heart Institute at the University of Sao Paulo Medical School Hospital in Brazil reported the analysis, which was part of the Medical, Angioplasty, or Surgery Study (MASS-II). That study compared the long-term effects of medical treatment, angioplasty, or surgical strategies in patients with stable angina symptoms of multivessel coronary artery disease (CAD) and preserved ventricular function, determining that surgery was the optimal approach in this patient subset (J. Am. Coll. Cardiol. 2004;43:1743-51)

“After 10 years of follow-up of stable CAD patients in MASS-II, the TG/HDL [triglyceride/high-density lipoprotein] ratio was the only lipid parameter independently associated” with major adverse cardiovascular events (MACE), Dr. Santos reported in the poster presentation.

The study randomly assigned 611 patients to coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or medical therapy. Lipid-modifying therapies were equally instituted in all study patient groups. Concentrations of total cholesterol, high-density lipoprotein (HDL), non-HDL cholesterol, and low-density lipoprotein (LDL) cholesterol, as well as LDL/HDL and TG/HDL ratios, were divided according to distribution quartiles. The associations between MACE occurrence and plasma lipids at baseline and at 6 months, as well as other risk factors and randomized CAD treatment, were determined by Cox regression models.

Mean levels of lipids were 150 mg/dL for TG, 37 mg/dL for HDL cholesterol, and 140 mg/dL for LDL cholesterol.

“LDL was not well treated at the time this study began 11 years ago. Only about one third of patients were on statins, and mean levels were about 140 mg/dL,” Dr. Santos said. “Yet, even in these patients with high LDL, the TG/HDL ratio was a marker for later events.”

In the MASS-II patients followed for an average of 11.4 years (range 9-15 years), MACE were observed in 42% of the PCI arm, 59% of the medical therapy arm, and 33% of the CABG arm.

After adjustment for confounders, the investigators found the following factors to be independently associated with MACE: age greater than 65 years, randomization to CABG versus medical therapy, systemic arterial hypertension, and TG/HDL ratio determined at 6 months.

For the TG/HDL ratio, the hazard ratio for the occurrence of MACE, comparing the highest and lowest quartiles of the ratios, was significant at 1.57 (P = .015). Hazard ratios for the third versus first quartiles was 1.38 (P = .098) and for the second versus first quartiles was 0.83 (P = .445). No association was found between MACE and other plasma lipids.

Among patients with a TG/HDL ratio greater than 6, only about 45% of patients were free of MACE at 10 years, compared with greater than 70% for those with a TG/HDL ratio of less than 3. 

“The TG/HDL ratio is a marker of residual risk,” Dr. Santos said. “For clinicians, this means that you treat the LDL, of course, but you need to look at triglycerides and HDL. While the lab doesn’t give you this ratio, it’s very easy to calculate.”

Dr. Gerald S. Berenson of Tulane University School of Medicine, New Orleans, and principal investigator of the Bogalusa Heart Study, viewed the poster with interest. “This is very important information,” he said. “The TG/HDL ratio is so easy to measure. Everyone is looking at particle size, and so forth, but we routinely get these levels, so you just need to look at the ratio. It’s a good measure of insulin resistance as well.”

Dr. Santos has served on the speakers bureaus of Novartis, Merck, Biolab, and Bristol-Myers Squibb. Dr. Berenson had no relevant conflicts of interest.

NEW ORLEANS  – In the 10-year follow-up of a study in patients with stable coronary artery disease, the ratio of triglycerides to high-density lipoproteins was highly predictive of major adverse cardiovascular events (MACE).

Dr. Raul D. Santos of the Heart Institute at the University of Sao Paulo Medical School Hospital in Brazil reported the analysis, which was part of the Medical, Angioplasty, or Surgery Study (MASS-II). That study compared the long-term effects of medical treatment, angioplasty, or surgical strategies in patients with stable angina symptoms of multivessel coronary artery disease (CAD) and preserved ventricular function, determining that surgery was the optimal approach in this patient subset (J. Am. Coll. Cardiol. 2004;43:1743-51)

“After 10 years of follow-up of stable CAD patients in MASS-II, the TG/HDL [triglyceride/high-density lipoprotein] ratio was the only lipid parameter independently associated” with major adverse cardiovascular events (MACE), Dr. Santos reported in the poster presentation.

The study randomly assigned 611 patients to coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or medical therapy. Lipid-modifying therapies were equally instituted in all study patient groups. Concentrations of total cholesterol, high-density lipoprotein (HDL), non-HDL cholesterol, and low-density lipoprotein (LDL) cholesterol, as well as LDL/HDL and TG/HDL ratios, were divided according to distribution quartiles. The associations between MACE occurrence and plasma lipids at baseline and at 6 months, as well as other risk factors and randomized CAD treatment, were determined by Cox regression models.

Mean levels of lipids were 150 mg/dL for TG, 37 mg/dL for HDL cholesterol, and 140 mg/dL for LDL cholesterol.

“LDL was not well treated at the time this study began 11 years ago. Only about one third of patients were on statins, and mean levels were about 140 mg/dL,” Dr. Santos said. “Yet, even in these patients with high LDL, the TG/HDL ratio was a marker for later events.”

In the MASS-II patients followed for an average of 11.4 years (range 9-15 years), MACE were observed in 42% of the PCI arm, 59% of the medical therapy arm, and 33% of the CABG arm.

After adjustment for confounders, the investigators found the following factors to be independently associated with MACE: age greater than 65 years, randomization to CABG versus medical therapy, systemic arterial hypertension, and TG/HDL ratio determined at 6 months.

For the TG/HDL ratio, the hazard ratio for the occurrence of MACE, comparing the highest and lowest quartiles of the ratios, was significant at 1.57 (P = .015). Hazard ratios for the third versus first quartiles was 1.38 (P = .098) and for the second versus first quartiles was 0.83 (P = .445). No association was found between MACE and other plasma lipids.

Among patients with a TG/HDL ratio greater than 6, only about 45% of patients were free of MACE at 10 years, compared with greater than 70% for those with a TG/HDL ratio of less than 3. 

“The TG/HDL ratio is a marker of residual risk,” Dr. Santos said. “For clinicians, this means that you treat the LDL, of course, but you need to look at triglycerides and HDL. While the lab doesn’t give you this ratio, it’s very easy to calculate.”

Dr. Gerald S. Berenson of Tulane University School of Medicine, New Orleans, and principal investigator of the Bogalusa Heart Study, viewed the poster with interest. “This is very important information,” he said. “The TG/HDL ratio is so easy to measure. Everyone is looking at particle size, and so forth, but we routinely get these levels, so you just need to look at the ratio. It’s a good measure of insulin resistance as well.”

Dr. Santos has served on the speakers bureaus of Novartis, Merck, Biolab, and Bristol-Myers Squibb. Dr. Berenson had no relevant conflicts of interest.

NEW ORLEANS  – In the 10-year follow-up of a study in patients with stable coronary artery disease, the ratio of triglycerides to high-density lipoproteins was highly predictive of major adverse cardiovascular events (MACE).

Dr. Raul D. Santos of the Heart Institute at the University of Sao Paulo Medical School Hospital in Brazil reported the analysis, which was part of the Medical, Angioplasty, or Surgery Study (MASS-II). That study compared the long-term effects of medical treatment, angioplasty, or surgical strategies in patients with stable angina symptoms of multivessel coronary artery disease (CAD) and preserved ventricular function, determining that surgery was the optimal approach in this patient subset (J. Am. Coll. Cardiol. 2004;43:1743-51)

“After 10 years of follow-up of stable CAD patients in MASS-II, the TG/HDL [triglyceride/high-density lipoprotein] ratio was the only lipid parameter independently associated” with major adverse cardiovascular events (MACE), Dr. Santos reported in the poster presentation.

The study randomly assigned 611 patients to coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or medical therapy. Lipid-modifying therapies were equally instituted in all study patient groups. Concentrations of total cholesterol, high-density lipoprotein (HDL), non-HDL cholesterol, and low-density lipoprotein (LDL) cholesterol, as well as LDL/HDL and TG/HDL ratios, were divided according to distribution quartiles. The associations between MACE occurrence and plasma lipids at baseline and at 6 months, as well as other risk factors and randomized CAD treatment, were determined by Cox regression models.

Mean levels of lipids were 150 mg/dL for TG, 37 mg/dL for HDL cholesterol, and 140 mg/dL for LDL cholesterol.

“LDL was not well treated at the time this study began 11 years ago. Only about one third of patients were on statins, and mean levels were about 140 mg/dL,” Dr. Santos said. “Yet, even in these patients with high LDL, the TG/HDL ratio was a marker for later events.”

In the MASS-II patients followed for an average of 11.4 years (range 9-15 years), MACE were observed in 42% of the PCI arm, 59% of the medical therapy arm, and 33% of the CABG arm.

After adjustment for confounders, the investigators found the following factors to be independently associated with MACE: age greater than 65 years, randomization to CABG versus medical therapy, systemic arterial hypertension, and TG/HDL ratio determined at 6 months.

For the TG/HDL ratio, the hazard ratio for the occurrence of MACE, comparing the highest and lowest quartiles of the ratios, was significant at 1.57 (P = .015). Hazard ratios for the third versus first quartiles was 1.38 (P = .098) and for the second versus first quartiles was 0.83 (P = .445). No association was found between MACE and other plasma lipids.

Among patients with a TG/HDL ratio greater than 6, only about 45% of patients were free of MACE at 10 years, compared with greater than 70% for those with a TG/HDL ratio of less than 3. 

“The TG/HDL ratio is a marker of residual risk,” Dr. Santos said. “For clinicians, this means that you treat the LDL, of course, but you need to look at triglycerides and HDL. While the lab doesn’t give you this ratio, it’s very easy to calculate.”

Dr. Gerald S. Berenson of Tulane University School of Medicine, New Orleans, and principal investigator of the Bogalusa Heart Study, viewed the poster with interest. “This is very important information,” he said. “The TG/HDL ratio is so easy to measure. Everyone is looking at particle size, and so forth, but we routinely get these levels, so you just need to look at the ratio. It’s a good measure of insulin resistance as well.”

Dr. Santos has served on the speakers bureaus of Novartis, Merck, Biolab, and Bristol-Myers Squibb. Dr. Berenson had no relevant conflicts of interest.

NEW ORLEANS  – In the 10-year follow-up of a study in patients with stable coronary artery disease, the ratio of triglycerides to high-density lipoproteins was highly predictive of major adverse cardiovascular events (MACE).

Dr. Raul D. Santos of the Heart Institute at the University of Sao Paulo Medical School Hospital in Brazil reported the analysis, which was part of the Medical, Angioplasty, or Surgery Study (MASS-II). That study compared the long-term effects of medical treatment, angioplasty, or surgical strategies in patients with stable angina symptoms of multivessel coronary artery disease (CAD) and preserved ventricular function, determining that surgery was the optimal approach in this patient subset (J. Am. Coll. Cardiol. 2004;43:1743-51)

“After 10 years of follow-up of stable CAD patients in MASS-II, the TG/HDL [triglyceride/high-density lipoprotein] ratio was the only lipid parameter independently associated” with major adverse cardiovascular events (MACE), Dr. Santos reported in the poster presentation.

The study randomly assigned 611 patients to coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or medical therapy. Lipid-modifying therapies were equally instituted in all study patient groups. Concentrations of total cholesterol, high-density lipoprotein (HDL), non-HDL cholesterol, and low-density lipoprotein (LDL) cholesterol, as well as LDL/HDL and TG/HDL ratios, were divided according to distribution quartiles. The associations between MACE occurrence and plasma lipids at baseline and at 6 months, as well as other risk factors and randomized CAD treatment, were determined by Cox regression models.

Mean levels of lipids were 150 mg/dL for TG, 37 mg/dL for HDL cholesterol, and 140 mg/dL for LDL cholesterol.

“LDL was not well treated at the time this study began 11 years ago. Only about one third of patients were on statins, and mean levels were about 140 mg/dL,” Dr. Santos said. “Yet, even in these patients with high LDL, the TG/HDL ratio was a marker for later events.”

In the MASS-II patients followed for an average of 11.4 years (range 9-15 years), MACE were observed in 42% of the PCI arm, 59% of the medical therapy arm, and 33% of the CABG arm.

After adjustment for confounders, the investigators found the following factors to be independently associated with MACE: age greater than 65 years, randomization to CABG versus medical therapy, systemic arterial hypertension, and TG/HDL ratio determined at 6 months.

For the TG/HDL ratio, the hazard ratio for the occurrence of MACE, comparing the highest and lowest quartiles of the ratios, was significant at 1.57 (P = .015). Hazard ratios for the third versus first quartiles was 1.38 (P = .098) and for the second versus first quartiles was 0.83 (P = .445). No association was found between MACE and other plasma lipids.

Among patients with a TG/HDL ratio greater than 6, only about 45% of patients were free of MACE at 10 years, compared with greater than 70% for those with a TG/HDL ratio of less than 3. 

“The TG/HDL ratio is a marker of residual risk,” Dr. Santos said. “For clinicians, this means that you treat the LDL, of course, but you need to look at triglycerides and HDL. While the lab doesn’t give you this ratio, it’s very easy to calculate.”

Dr. Gerald S. Berenson of Tulane University School of Medicine, New Orleans, and principal investigator of the Bogalusa Heart Study, viewed the poster with interest. “This is very important information,” he said. “The TG/HDL ratio is so easy to measure. Everyone is looking at particle size, and so forth, but we routinely get these levels, so you just need to look at the ratio. It’s a good measure of insulin resistance as well.”

Dr. Santos has served on the speakers bureaus of Novartis, Merck, Biolab, and Bristol-Myers Squibb. Dr. Berenson had no relevant conflicts of interest.