ACC 2011

NEW ORLEANS – The investigational oral anticoagulant rivaroxaban was as effective as injection enoxaparin in preventing venous thromboembolism at 10 days and superior at 35 days among critically ill hospitalized patients in the phase III MAGELLAN study.

Overall bleeding rates were low, at about 1%, but were significantly higher in patients receiving rivaroxaban across the entire study period, lead author Dr. Alexander T. Cohen said April 5 at the annual meeting of the American College of Cardiology.

"MAGELLAN confirms that there is a continued risk of VTE [venous thromboembolism] beyond the initial period of hospitalization, and I believe this is an important finding because the benchmark data said we should get a figure of 4%, and we got a figure of 5.7% at day 45," he said.

The study randomly assigned 8,101 patients hospitalized for an acute medical illness including heart failure, acute infectious disease, and acute respiratory insufficiency to oral rivaroxaban 10 mg daily for 35 days or subcutaneous enoxaparin 40 mg daily for 10 days plus placebo.

At day 10, the primary composite efficacy end point, defined as the cumulative incidence of asymptomatic proximal deep venous thromboembolism (DVT) detected by ultrasonography, symptomatic DVT, symptomatic nonfatal pulmonary embolism (PE), and VTE-related death, occurred in 2.7% of patients in both arms, reaching the prespecified noninferiority benchmark for day 10.

At 35 days, significantly fewer rivaroxaban patients experienced the primary efficacy end point, at 4.4% vs. 5.7% of patients in the enoxaparin arm, reaching the superiority end point for day 35. The absolute risk reduction was 1.3% and the relative risk reduction was 23%, said Dr. Cohen, who is with King’s College in London.

Clinically relevant bleeding occurred significantly more often in the rivaroxaban group than in the enoxaparin group from day 1 to 10 (2.8% vs. 1.2%), from day 1 to 35 (4.1% vs. 1.7%), and from day 11 to 35 (1.4% vs. 0.5%).

Among major bleeding events, a drop in hemoglobin of 2 g/dL or more was observed in 31 rivaroxaban patients and 10 enoxaparin patients, 2 or more units of blood were transfused in 34 and 8 patients, respectively, and critical site bleeds occurred in 9 and 4 patients, respectively.

Notably, seven rivaroxaban patients died of fatal bleeds, compared with only one enoxaparin patient. Overall, about 5% of patients in the trial died of all causes.

The net clinical benefit was 9.4% for rivaroxaban and 7.8% for enoxaparin. Based on the prespecified net clinical benefit analysis, Dr. Cohen acknowledged that a consistently positive benefit-risk balance was not seen among the cohort, but that they plan to conduct subgroup analyses to determine factors related to bleeding and to identify patients who might derive greater benefit from thromboprophylaxis with rivaroxaban.

He stressed that the study used a highly sensitive analysis of bleeding, such as a drop in hemoglobin of just 2 g/dL, and that even nosebleeds and bruising were counted in the risk-benefit analysis. When asked whether removal of these lesser bleeding events would result in a positive clinical benefit for rivaroxaban, Dr. Cohen said he was hesitant to speculate outside the trial’s prespecified outcome measures. When pressed further, he replied, "If we looked at a traditional risk-benefit analysis of major bleeds, then the picture swings back the other way. ... It would start to look more favorable toward rivaroxaban, but I have to stick to the study protocol."

When asked whether he had a theory as to why fatal bleeds occurred, Dr. Cohen pointed out that while there were 7 bleeding deaths with rivaroxaban and only 1 with enoxaparin, there were 30 PE-related deaths with enoxaparin and 19 with rivaroxaban.

"So we saved 11 lives from blood clots, if you want to [make that sort of analysis], and lost 6 lives through bleeding," he said.

In a separate interview, Dr. A. Michael Lincoff, director of the Cleveland Clinic Coordinating Center for Clinical Research, said numerous studies have shown that the risk of DVT persists beyond the acute hospitalization period and that the ability to give rivaroxaban after patients are discharged is valuable.

"It’s a much more practical drug to send patients home on," he said in an interview. "Yes, you can train patients to inject themselves with enoxaparin, but it’s not well accepted in many cases."

Dr. Cohen reported financial ties with more than a dozen pharmaceutical companies, including Bayer (maker of rivaroxaban). Dr. Lincoff had no relevant disclosures.

NEW ORLEANS – The investigational oral anticoagulant rivaroxaban was as effective as injection enoxaparin in preventing venous thromboembolism at 10 days and superior at 35 days among critically ill hospitalized patients in the phase III MAGELLAN study.

Overall bleeding rates were low, at about 1%, but were significantly higher in patients receiving rivaroxaban across the entire study period, lead author Dr. Alexander T. Cohen said April 5 at the annual meeting of the American College of Cardiology.

"MAGELLAN confirms that there is a continued risk of VTE [venous thromboembolism] beyond the initial period of hospitalization, and I believe this is an important finding because the benchmark data said we should get a figure of 4%, and we got a figure of 5.7% at day 45," he said.

The study randomly assigned 8,101 patients hospitalized for an acute medical illness including heart failure, acute infectious disease, and acute respiratory insufficiency to oral rivaroxaban 10 mg daily for 35 days or subcutaneous enoxaparin 40 mg daily for 10 days plus placebo.

At day 10, the primary composite efficacy end point, defined as the cumulative incidence of asymptomatic proximal deep venous thromboembolism (DVT) detected by ultrasonography, symptomatic DVT, symptomatic nonfatal pulmonary embolism (PE), and VTE-related death, occurred in 2.7% of patients in both arms, reaching the prespecified noninferiority benchmark for day 10.

At 35 days, significantly fewer rivaroxaban patients experienced the primary efficacy end point, at 4.4% vs. 5.7% of patients in the enoxaparin arm, reaching the superiority end point for day 35. The absolute risk reduction was 1.3% and the relative risk reduction was 23%, said Dr. Cohen, who is with King’s College in London.

Clinically relevant bleeding occurred significantly more often in the rivaroxaban group than in the enoxaparin group from day 1 to 10 (2.8% vs. 1.2%), from day 1 to 35 (4.1% vs. 1.7%), and from day 11 to 35 (1.4% vs. 0.5%).

Among major bleeding events, a drop in hemoglobin of 2 g/dL or more was observed in 31 rivaroxaban patients and 10 enoxaparin patients, 2 or more units of blood were transfused in 34 and 8 patients, respectively, and critical site bleeds occurred in 9 and 4 patients, respectively.

Notably, seven rivaroxaban patients died of fatal bleeds, compared with only one enoxaparin patient. Overall, about 5% of patients in the trial died of all causes.

The net clinical benefit was 9.4% for rivaroxaban and 7.8% for enoxaparin. Based on the prespecified net clinical benefit analysis, Dr. Cohen acknowledged that a consistently positive benefit-risk balance was not seen among the cohort, but that they plan to conduct subgroup analyses to determine factors related to bleeding and to identify patients who might derive greater benefit from thromboprophylaxis with rivaroxaban.

He stressed that the study used a highly sensitive analysis of bleeding, such as a drop in hemoglobin of just 2 g/dL, and that even nosebleeds and bruising were counted in the risk-benefit analysis. When asked whether removal of these lesser bleeding events would result in a positive clinical benefit for rivaroxaban, Dr. Cohen said he was hesitant to speculate outside the trial’s prespecified outcome measures. When pressed further, he replied, "If we looked at a traditional risk-benefit analysis of major bleeds, then the picture swings back the other way. ... It would start to look more favorable toward rivaroxaban, but I have to stick to the study protocol."

When asked whether he had a theory as to why fatal bleeds occurred, Dr. Cohen pointed out that while there were 7 bleeding deaths with rivaroxaban and only 1 with enoxaparin, there were 30 PE-related deaths with enoxaparin and 19 with rivaroxaban.

"So we saved 11 lives from blood clots, if you want to [make that sort of analysis], and lost 6 lives through bleeding," he said.

In a separate interview, Dr. A. Michael Lincoff, director of the Cleveland Clinic Coordinating Center for Clinical Research, said numerous studies have shown that the risk of DVT persists beyond the acute hospitalization period and that the ability to give rivaroxaban after patients are discharged is valuable.

"It’s a much more practical drug to send patients home on," he said in an interview. "Yes, you can train patients to inject themselves with enoxaparin, but it’s not well accepted in many cases."

Dr. Cohen reported financial ties with more than a dozen pharmaceutical companies, including Bayer (maker of rivaroxaban). Dr. Lincoff had no relevant disclosures.

NEW ORLEANS – The investigational oral anticoagulant rivaroxaban was as effective as injection enoxaparin in preventing venous thromboembolism at 10 days and superior at 35 days among critically ill hospitalized patients in the phase III MAGELLAN study.

Overall bleeding rates were low, at about 1%, but were significantly higher in patients receiving rivaroxaban across the entire study period, lead author Dr. Alexander T. Cohen said April 5 at the annual meeting of the American College of Cardiology.

"MAGELLAN confirms that there is a continued risk of VTE [venous thromboembolism] beyond the initial period of hospitalization, and I believe this is an important finding because the benchmark data said we should get a figure of 4%, and we got a figure of 5.7% at day 45," he said.

The study randomly assigned 8,101 patients hospitalized for an acute medical illness including heart failure, acute infectious disease, and acute respiratory insufficiency to oral rivaroxaban 10 mg daily for 35 days or subcutaneous enoxaparin 40 mg daily for 10 days plus placebo.

At day 10, the primary composite efficacy end point, defined as the cumulative incidence of asymptomatic proximal deep venous thromboembolism (DVT) detected by ultrasonography, symptomatic DVT, symptomatic nonfatal pulmonary embolism (PE), and VTE-related death, occurred in 2.7% of patients in both arms, reaching the prespecified noninferiority benchmark for day 10.

At 35 days, significantly fewer rivaroxaban patients experienced the primary efficacy end point, at 4.4% vs. 5.7% of patients in the enoxaparin arm, reaching the superiority end point for day 35. The absolute risk reduction was 1.3% and the relative risk reduction was 23%, said Dr. Cohen, who is with King’s College in London.

Clinically relevant bleeding occurred significantly more often in the rivaroxaban group than in the enoxaparin group from day 1 to 10 (2.8% vs. 1.2%), from day 1 to 35 (4.1% vs. 1.7%), and from day 11 to 35 (1.4% vs. 0.5%).

Among major bleeding events, a drop in hemoglobin of 2 g/dL or more was observed in 31 rivaroxaban patients and 10 enoxaparin patients, 2 or more units of blood were transfused in 34 and 8 patients, respectively, and critical site bleeds occurred in 9 and 4 patients, respectively.

Notably, seven rivaroxaban patients died of fatal bleeds, compared with only one enoxaparin patient. Overall, about 5% of patients in the trial died of all causes.

The net clinical benefit was 9.4% for rivaroxaban and 7.8% for enoxaparin. Based on the prespecified net clinical benefit analysis, Dr. Cohen acknowledged that a consistently positive benefit-risk balance was not seen among the cohort, but that they plan to conduct subgroup analyses to determine factors related to bleeding and to identify patients who might derive greater benefit from thromboprophylaxis with rivaroxaban.

He stressed that the study used a highly sensitive analysis of bleeding, such as a drop in hemoglobin of just 2 g/dL, and that even nosebleeds and bruising were counted in the risk-benefit analysis. When asked whether removal of these lesser bleeding events would result in a positive clinical benefit for rivaroxaban, Dr. Cohen said he was hesitant to speculate outside the trial’s prespecified outcome measures. When pressed further, he replied, "If we looked at a traditional risk-benefit analysis of major bleeds, then the picture swings back the other way. ... It would start to look more favorable toward rivaroxaban, but I have to stick to the study protocol."

When asked whether he had a theory as to why fatal bleeds occurred, Dr. Cohen pointed out that while there were 7 bleeding deaths with rivaroxaban and only 1 with enoxaparin, there were 30 PE-related deaths with enoxaparin and 19 with rivaroxaban.

"So we saved 11 lives from blood clots, if you want to [make that sort of analysis], and lost 6 lives through bleeding," he said.

In a separate interview, Dr. A. Michael Lincoff, director of the Cleveland Clinic Coordinating Center for Clinical Research, said numerous studies have shown that the risk of DVT persists beyond the acute hospitalization period and that the ability to give rivaroxaban after patients are discharged is valuable.

"It’s a much more practical drug to send patients home on," he said in an interview. "Yes, you can train patients to inject themselves with enoxaparin, but it’s not well accepted in many cases."

Dr. Cohen reported financial ties with more than a dozen pharmaceutical companies, including Bayer (maker of rivaroxaban). Dr. Lincoff had no relevant disclosures.

NEW ORLEANS – The investigational oral anticoagulant rivaroxaban was as effective as injection enoxaparin in preventing venous thromboembolism at 10 days and superior at 35 days among critically ill hospitalized patients in the phase III MAGELLAN study.

Overall bleeding rates were low, at about 1%, but were significantly higher in patients receiving rivaroxaban across the entire study period, lead author Dr. Alexander T. Cohen said April 5 at the annual meeting of the American College of Cardiology.

"MAGELLAN confirms that there is a continued risk of VTE [venous thromboembolism] beyond the initial period of hospitalization, and I believe this is an important finding because the benchmark data said we should get a figure of 4%, and we got a figure of 5.7% at day 45," he said.

The study randomly assigned 8,101 patients hospitalized for an acute medical illness including heart failure, acute infectious disease, and acute respiratory insufficiency to oral rivaroxaban 10 mg daily for 35 days or subcutaneous enoxaparin 40 mg daily for 10 days plus placebo.

At day 10, the primary composite efficacy end point, defined as the cumulative incidence of asymptomatic proximal deep venous thromboembolism (DVT) detected by ultrasonography, symptomatic DVT, symptomatic nonfatal pulmonary embolism (PE), and VTE-related death, occurred in 2.7% of patients in both arms, reaching the prespecified noninferiority benchmark for day 10.

At 35 days, significantly fewer rivaroxaban patients experienced the primary efficacy end point, at 4.4% vs. 5.7% of patients in the enoxaparin arm, reaching the superiority end point for day 35. The absolute risk reduction was 1.3% and the relative risk reduction was 23%, said Dr. Cohen, who is with King’s College in London.

Clinically relevant bleeding occurred significantly more often in the rivaroxaban group than in the enoxaparin group from day 1 to 10 (2.8% vs. 1.2%), from day 1 to 35 (4.1% vs. 1.7%), and from day 11 to 35 (1.4% vs. 0.5%).

Among major bleeding events, a drop in hemoglobin of 2 g/dL or more was observed in 31 rivaroxaban patients and 10 enoxaparin patients, 2 or more units of blood were transfused in 34 and 8 patients, respectively, and critical site bleeds occurred in 9 and 4 patients, respectively.

Notably, seven rivaroxaban patients died of fatal bleeds, compared with only one enoxaparin patient. Overall, about 5% of patients in the trial died of all causes.

The net clinical benefit was 9.4% for rivaroxaban and 7.8% for enoxaparin. Based on the prespecified net clinical benefit analysis, Dr. Cohen acknowledged that a consistently positive benefit-risk balance was not seen among the cohort, but that they plan to conduct subgroup analyses to determine factors related to bleeding and to identify patients who might derive greater benefit from thromboprophylaxis with rivaroxaban.

He stressed that the study used a highly sensitive analysis of bleeding, such as a drop in hemoglobin of just 2 g/dL, and that even nosebleeds and bruising were counted in the risk-benefit analysis. When asked whether removal of these lesser bleeding events would result in a positive clinical benefit for rivaroxaban, Dr. Cohen said he was hesitant to speculate outside the trial’s prespecified outcome measures. When pressed further, he replied, "If we looked at a traditional risk-benefit analysis of major bleeds, then the picture swings back the other way. ... It would start to look more favorable toward rivaroxaban, but I have to stick to the study protocol."

When asked whether he had a theory as to why fatal bleeds occurred, Dr. Cohen pointed out that while there were 7 bleeding deaths with rivaroxaban and only 1 with enoxaparin, there were 30 PE-related deaths with enoxaparin and 19 with rivaroxaban.

"So we saved 11 lives from blood clots, if you want to [make that sort of analysis], and lost 6 lives through bleeding," he said.

In a separate interview, Dr. A. Michael Lincoff, director of the Cleveland Clinic Coordinating Center for Clinical Research, said numerous studies have shown that the risk of DVT persists beyond the acute hospitalization period and that the ability to give rivaroxaban after patients are discharged is valuable.

"It’s a much more practical drug to send patients home on," he said in an interview. "Yes, you can train patients to inject themselves with enoxaparin, but it’s not well accepted in many cases."

Dr. Cohen reported financial ties with more than a dozen pharmaceutical companies, including Bayer (maker of rivaroxaban). Dr. Lincoff had no relevant disclosures.

NEW ORLEANS – The investigational oral anticoagulant rivaroxaban was as effective as injection enoxaparin in preventing venous thromboembolism at 10 days and superior at 35 days among critically ill hospitalized patients in the phase III MAGELLAN study.

Overall bleeding rates were low, at about 1%, but were significantly higher in patients receiving rivaroxaban across the entire study period, lead author Dr. Alexander T. Cohen said April 5 at the annual meeting of the American College of Cardiology.

"MAGELLAN confirms that there is a continued risk of VTE [venous thromboembolism] beyond the initial period of hospitalization, and I believe this is an important finding because the benchmark data said we should get a figure of 4%, and we got a figure of 5.7% at day 45," he said.

The study randomly assigned 8,101 patients hospitalized for an acute medical illness including heart failure, acute infectious disease, and acute respiratory insufficiency to oral rivaroxaban 10 mg daily for 35 days or subcutaneous enoxaparin 40 mg daily for 10 days plus placebo.

At day 10, the primary composite efficacy end point, defined as the cumulative incidence of asymptomatic proximal deep venous thromboembolism (DVT) detected by ultrasonography, symptomatic DVT, symptomatic nonfatal pulmonary embolism (PE), and VTE-related death, occurred in 2.7% of patients in both arms, reaching the prespecified noninferiority benchmark for day 10.

At 35 days, significantly fewer rivaroxaban patients experienced the primary efficacy end point, at 4.4% vs. 5.7% of patients in the enoxaparin arm, reaching the superiority end point for day 35. The absolute risk reduction was 1.3% and the relative risk reduction was 23%, said Dr. Cohen, who is with King’s College in London.

Clinically relevant bleeding occurred significantly more often in the rivaroxaban group than in the enoxaparin group from day 1 to 10 (2.8% vs. 1.2%), from day 1 to 35 (4.1% vs. 1.7%), and from day 11 to 35 (1.4% vs. 0.5%).

Among major bleeding events, a drop in hemoglobin of 2 g/dL or more was observed in 31 rivaroxaban patients and 10 enoxaparin patients, 2 or more units of blood were transfused in 34 and 8 patients, respectively, and critical site bleeds occurred in 9 and 4 patients, respectively.

Notably, seven rivaroxaban patients died of fatal bleeds, compared with only one enoxaparin patient. Overall, about 5% of patients in the trial died of all causes.

The net clinical benefit was 9.4% for rivaroxaban and 7.8% for enoxaparin. Based on the prespecified net clinical benefit analysis, Dr. Cohen acknowledged that a consistently positive benefit-risk balance was not seen among the cohort, but that they plan to conduct subgroup analyses to determine factors related to bleeding and to identify patients who might derive greater benefit from thromboprophylaxis with rivaroxaban.

He stressed that the study used a highly sensitive analysis of bleeding, such as a drop in hemoglobin of just 2 g/dL, and that even nosebleeds and bruising were counted in the risk-benefit analysis. When asked whether removal of these lesser bleeding events would result in a positive clinical benefit for rivaroxaban, Dr. Cohen said he was hesitant to speculate outside the trial’s prespecified outcome measures. When pressed further, he replied, "If we looked at a traditional risk-benefit analysis of major bleeds, then the picture swings back the other way. ... It would start to look more favorable toward rivaroxaban, but I have to stick to the study protocol."

When asked whether he had a theory as to why fatal bleeds occurred, Dr. Cohen pointed out that while there were 7 bleeding deaths with rivaroxaban and only 1 with enoxaparin, there were 30 PE-related deaths with enoxaparin and 19 with rivaroxaban.

"So we saved 11 lives from blood clots, if you want to [make that sort of analysis], and lost 6 lives through bleeding," he said.

In a separate interview, Dr. A. Michael Lincoff, director of the Cleveland Clinic Coordinating Center for Clinical Research, said numerous studies have shown that the risk of DVT persists beyond the acute hospitalization period and that the ability to give rivaroxaban after patients are discharged is valuable.

"It’s a much more practical drug to send patients home on," he said in an interview. "Yes, you can train patients to inject themselves with enoxaparin, but it’s not well accepted in many cases."

Dr. Cohen reported financial ties with more than a dozen pharmaceutical companies, including Bayer (maker of rivaroxaban). Dr. Lincoff had no relevant disclosures.

NEW ORLEANS – The investigational oral anticoagulant rivaroxaban was as effective as injection enoxaparin in preventing venous thromboembolism at 10 days and superior at 35 days among critically ill hospitalized patients in the phase III MAGELLAN study.

Overall bleeding rates were low, at about 1%, but were significantly higher in patients receiving rivaroxaban across the entire study period, lead author Dr. Alexander T. Cohen said April 5 at the annual meeting of the American College of Cardiology.

"MAGELLAN confirms that there is a continued risk of VTE [venous thromboembolism] beyond the initial period of hospitalization, and I believe this is an important finding because the benchmark data said we should get a figure of 4%, and we got a figure of 5.7% at day 45," he said.

The study randomly assigned 8,101 patients hospitalized for an acute medical illness including heart failure, acute infectious disease, and acute respiratory insufficiency to oral rivaroxaban 10 mg daily for 35 days or subcutaneous enoxaparin 40 mg daily for 10 days plus placebo.

At day 10, the primary composite efficacy end point, defined as the cumulative incidence of asymptomatic proximal deep venous thromboembolism (DVT) detected by ultrasonography, symptomatic DVT, symptomatic nonfatal pulmonary embolism (PE), and VTE-related death, occurred in 2.7% of patients in both arms, reaching the prespecified noninferiority benchmark for day 10.

At 35 days, significantly fewer rivaroxaban patients experienced the primary efficacy end point, at 4.4% vs. 5.7% of patients in the enoxaparin arm, reaching the superiority end point for day 35. The absolute risk reduction was 1.3% and the relative risk reduction was 23%, said Dr. Cohen, who is with King’s College in London.

Clinically relevant bleeding occurred significantly more often in the rivaroxaban group than in the enoxaparin group from day 1 to 10 (2.8% vs. 1.2%), from day 1 to 35 (4.1% vs. 1.7%), and from day 11 to 35 (1.4% vs. 0.5%).

Among major bleeding events, a drop in hemoglobin of 2 g/dL or more was observed in 31 rivaroxaban patients and 10 enoxaparin patients, 2 or more units of blood were transfused in 34 and 8 patients, respectively, and critical site bleeds occurred in 9 and 4 patients, respectively.

Notably, seven rivaroxaban patients died of fatal bleeds, compared with only one enoxaparin patient. Overall, about 5% of patients in the trial died of all causes.

The net clinical benefit was 9.4% for rivaroxaban and 7.8% for enoxaparin. Based on the prespecified net clinical benefit analysis, Dr. Cohen acknowledged that a consistently positive benefit-risk balance was not seen among the cohort, but that they plan to conduct subgroup analyses to determine factors related to bleeding and to identify patients who might derive greater benefit from thromboprophylaxis with rivaroxaban.

He stressed that the study used a highly sensitive analysis of bleeding, such as a drop in hemoglobin of just 2 g/dL, and that even nosebleeds and bruising were counted in the risk-benefit analysis. When asked whether removal of these lesser bleeding events would result in a positive clinical benefit for rivaroxaban, Dr. Cohen said he was hesitant to speculate outside the trial’s prespecified outcome measures. When pressed further, he replied, "If we looked at a traditional risk-benefit analysis of major bleeds, then the picture swings back the other way. ... It would start to look more favorable toward rivaroxaban, but I have to stick to the study protocol."

When asked whether he had a theory as to why fatal bleeds occurred, Dr. Cohen pointed out that while there were 7 bleeding deaths with rivaroxaban and only 1 with enoxaparin, there were 30 PE-related deaths with enoxaparin and 19 with rivaroxaban.

"So we saved 11 lives from blood clots, if you want to [make that sort of analysis], and lost 6 lives through bleeding," he said.

In a separate interview, Dr. A. Michael Lincoff, director of the Cleveland Clinic Coordinating Center for Clinical Research, said numerous studies have shown that the risk of DVT persists beyond the acute hospitalization period and that the ability to give rivaroxaban after patients are discharged is valuable.

"It’s a much more practical drug to send patients home on," he said in an interview. "Yes, you can train patients to inject themselves with enoxaparin, but it’s not well accepted in many cases."

Dr. Cohen reported financial ties with more than a dozen pharmaceutical companies, including Bayer (maker of rivaroxaban). Dr. Lincoff had no relevant disclosures.

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 – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post-coronary artery bypass graft, according to the largest study ever performed to compare these two types of stents in this setting.

Specifically, drug-eluting stents (DES) significantly reduced the rate for the combined primary end point of death, myocardial infarction, and repeat revascularization procedures in the ISAR (Intracoronary Stenting and Antithrombotic Regimen) –CABG trial, presented at the annual meeting of the American College of Cardiology on April 4.

"This study shows us that we don’t have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents]," said Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR at the German Heart Center in Munich.

DES have been shown to be more effective and as safe as BMS in native coronary artery lesions. Saphenous vein grafts are used extensively in CABG surgery, but in a high percentage of patients, these grafts are vulnerable to atherosclerosis and subsequent restenosis. The options for re-opening the vein graft include angioplasty with a stent and a second CABG, which carries higher mortality and morbidity risks than the first CABG.

Only two small studies have compared DES versus BMS in saphenous vein graft lesions, and they had conflicting results. The larger ISAR-CABG is powered for clinical events.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of drug-eluting stents (Cypher, Taxus, and BP Sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up post percutaneous coronary intervention (PCI) for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Mean age was about 71.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, the saphenous vein graft was about 13.5 years old, and about 55% had a previous history of myocardial infarction. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts. TIMI flow rates pre- and post-PCI were similar between the two groups as well.

At 1 year, DES reduced the risk of the primary end point by 35%, compared with BMS, with rates of 15.4% and 22.1%, respectively, a significant difference. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or myocardial infarction were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

"Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients," Dr. Mehilli said.

Dr. Steven R. Bailey commented that, "This study was designed to answer appropriate questions." However, "It is surprising that there were so few females," added Dr. Bailey of the University of Texas Health Sciences Center, San Antonio.

He asked Dr. Mehilli if drug-eluting stents were compared with bare metal stents in subsets related to the complexity of saphenous vein graft lesions. She replied that a subgroup analysis of ISAR-CABG will be forthcoming.

Dr. Mehilli said that, in Germany, the overwhelming number of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli disclosed lecture fees from Abbott. Dr. Bailey has received consulting fees/honoraria from Volcano Corp.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post-coronary artery bypass graft, according to the largest study ever performed to compare these two types of stents in this setting.

Specifically, drug-eluting stents (DES) significantly reduced the rate for the combined primary end point of death, myocardial infarction, and repeat revascularization procedures in the ISAR (Intracoronary Stenting and Antithrombotic Regimen) –CABG trial, presented at the annual meeting of the American College of Cardiology on April 4.

"This study shows us that we don’t have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents]," said Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR at the German Heart Center in Munich.

DES have been shown to be more effective and as safe as BMS in native coronary artery lesions. Saphenous vein grafts are used extensively in CABG surgery, but in a high percentage of patients, these grafts are vulnerable to atherosclerosis and subsequent restenosis. The options for re-opening the vein graft include angioplasty with a stent and a second CABG, which carries higher mortality and morbidity risks than the first CABG.

Only two small studies have compared DES versus BMS in saphenous vein graft lesions, and they had conflicting results. The larger ISAR-CABG is powered for clinical events.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of drug-eluting stents (Cypher, Taxus, and BP Sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up post percutaneous coronary intervention (PCI) for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Mean age was about 71.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, the saphenous vein graft was about 13.5 years old, and about 55% had a previous history of myocardial infarction. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts. TIMI flow rates pre- and post-PCI were similar between the two groups as well.

At 1 year, DES reduced the risk of the primary end point by 35%, compared with BMS, with rates of 15.4% and 22.1%, respectively, a significant difference. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or myocardial infarction were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

"Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients," Dr. Mehilli said.

Dr. Steven R. Bailey commented that, "This study was designed to answer appropriate questions." However, "It is surprising that there were so few females," added Dr. Bailey of the University of Texas Health Sciences Center, San Antonio.

He asked Dr. Mehilli if drug-eluting stents were compared with bare metal stents in subsets related to the complexity of saphenous vein graft lesions. She replied that a subgroup analysis of ISAR-CABG will be forthcoming.

Dr. Mehilli said that, in Germany, the overwhelming number of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli disclosed lecture fees from Abbott. Dr. Bailey has received consulting fees/honoraria from Volcano Corp.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post-coronary artery bypass graft, according to the largest study ever performed to compare these two types of stents in this setting.

Specifically, drug-eluting stents (DES) significantly reduced the rate for the combined primary end point of death, myocardial infarction, and repeat revascularization procedures in the ISAR (Intracoronary Stenting and Antithrombotic Regimen) –CABG trial, presented at the annual meeting of the American College of Cardiology on April 4.

"This study shows us that we don’t have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents]," said Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR at the German Heart Center in Munich.

DES have been shown to be more effective and as safe as BMS in native coronary artery lesions. Saphenous vein grafts are used extensively in CABG surgery, but in a high percentage of patients, these grafts are vulnerable to atherosclerosis and subsequent restenosis. The options for re-opening the vein graft include angioplasty with a stent and a second CABG, which carries higher mortality and morbidity risks than the first CABG.

Only two small studies have compared DES versus BMS in saphenous vein graft lesions, and they had conflicting results. The larger ISAR-CABG is powered for clinical events.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of drug-eluting stents (Cypher, Taxus, and BP Sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up post percutaneous coronary intervention (PCI) for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Mean age was about 71.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, the saphenous vein graft was about 13.5 years old, and about 55% had a previous history of myocardial infarction. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts. TIMI flow rates pre- and post-PCI were similar between the two groups as well.

At 1 year, DES reduced the risk of the primary end point by 35%, compared with BMS, with rates of 15.4% and 22.1%, respectively, a significant difference. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or myocardial infarction were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

"Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients," Dr. Mehilli said.

Dr. Steven R. Bailey commented that, "This study was designed to answer appropriate questions." However, "It is surprising that there were so few females," added Dr. Bailey of the University of Texas Health Sciences Center, San Antonio.

He asked Dr. Mehilli if drug-eluting stents were compared with bare metal stents in subsets related to the complexity of saphenous vein graft lesions. She replied that a subgroup analysis of ISAR-CABG will be forthcoming.

Dr. Mehilli said that, in Germany, the overwhelming number of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli disclosed lecture fees from Abbott. Dr. Bailey has received consulting fees/honoraria from Volcano Corp.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post-coronary artery bypass graft, according to the largest study ever performed to compare these two types of stents in this setting.

Specifically, drug-eluting stents (DES) significantly reduced the rate for the combined primary end point of death, myocardial infarction, and repeat revascularization procedures in the ISAR (Intracoronary Stenting and Antithrombotic Regimen) –CABG trial, presented at the annual meeting of the American College of Cardiology on April 4.

"This study shows us that we don’t have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents]," said Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR at the German Heart Center in Munich.

DES have been shown to be more effective and as safe as BMS in native coronary artery lesions. Saphenous vein grafts are used extensively in CABG surgery, but in a high percentage of patients, these grafts are vulnerable to atherosclerosis and subsequent restenosis. The options for re-opening the vein graft include angioplasty with a stent and a second CABG, which carries higher mortality and morbidity risks than the first CABG.

Only two small studies have compared DES versus BMS in saphenous vein graft lesions, and they had conflicting results. The larger ISAR-CABG is powered for clinical events.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of drug-eluting stents (Cypher, Taxus, and BP Sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up post percutaneous coronary intervention (PCI) for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Mean age was about 71.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, the saphenous vein graft was about 13.5 years old, and about 55% had a previous history of myocardial infarction. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts. TIMI flow rates pre- and post-PCI were similar between the two groups as well.

At 1 year, DES reduced the risk of the primary end point by 35%, compared with BMS, with rates of 15.4% and 22.1%, respectively, a significant difference. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or myocardial infarction were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

"Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients," Dr. Mehilli said.

Dr. Steven R. Bailey commented that, "This study was designed to answer appropriate questions." However, "It is surprising that there were so few females," added Dr. Bailey of the University of Texas Health Sciences Center, San Antonio.

He asked Dr. Mehilli if drug-eluting stents were compared with bare metal stents in subsets related to the complexity of saphenous vein graft lesions. She replied that a subgroup analysis of ISAR-CABG will be forthcoming.

Dr. Mehilli said that, in Germany, the overwhelming number of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli disclosed lecture fees from Abbott. Dr. Bailey has received consulting fees/honoraria from Volcano Corp.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post-coronary artery bypass graft, according to the largest study ever performed to compare these two types of stents in this setting.

Specifically, drug-eluting stents (DES) significantly reduced the rate for the combined primary end point of death, myocardial infarction, and repeat revascularization procedures in the ISAR (Intracoronary Stenting and Antithrombotic Regimen) –CABG trial, presented at the annual meeting of the American College of Cardiology on April 4.

"This study shows us that we don’t have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents]," said Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR at the German Heart Center in Munich.

DES have been shown to be more effective and as safe as BMS in native coronary artery lesions. Saphenous vein grafts are used extensively in CABG surgery, but in a high percentage of patients, these grafts are vulnerable to atherosclerosis and subsequent restenosis. The options for re-opening the vein graft include angioplasty with a stent and a second CABG, which carries higher mortality and morbidity risks than the first CABG.

Only two small studies have compared DES versus BMS in saphenous vein graft lesions, and they had conflicting results. The larger ISAR-CABG is powered for clinical events.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of drug-eluting stents (Cypher, Taxus, and BP Sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up post percutaneous coronary intervention (PCI) for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Mean age was about 71.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, the saphenous vein graft was about 13.5 years old, and about 55% had a previous history of myocardial infarction. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts. TIMI flow rates pre- and post-PCI were similar between the two groups as well.

At 1 year, DES reduced the risk of the primary end point by 35%, compared with BMS, with rates of 15.4% and 22.1%, respectively, a significant difference. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or myocardial infarction were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

"Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients," Dr. Mehilli said.

Dr. Steven R. Bailey commented that, "This study was designed to answer appropriate questions." However, "It is surprising that there were so few females," added Dr. Bailey of the University of Texas Health Sciences Center, San Antonio.

He asked Dr. Mehilli if drug-eluting stents were compared with bare metal stents in subsets related to the complexity of saphenous vein graft lesions. She replied that a subgroup analysis of ISAR-CABG will be forthcoming.

Dr. Mehilli said that, in Germany, the overwhelming number of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli disclosed lecture fees from Abbott. Dr. Bailey has received consulting fees/honoraria from Volcano Corp.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post-coronary artery bypass graft, according to the largest study ever performed to compare these two types of stents in this setting.

Specifically, drug-eluting stents (DES) significantly reduced the rate for the combined primary end point of death, myocardial infarction, and repeat revascularization procedures in the ISAR (Intracoronary Stenting and Antithrombotic Regimen) –CABG trial, presented at the annual meeting of the American College of Cardiology on April 4.

"This study shows us that we don’t have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents]," said Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR at the German Heart Center in Munich.

DES have been shown to be more effective and as safe as BMS in native coronary artery lesions. Saphenous vein grafts are used extensively in CABG surgery, but in a high percentage of patients, these grafts are vulnerable to atherosclerosis and subsequent restenosis. The options for re-opening the vein graft include angioplasty with a stent and a second CABG, which carries higher mortality and morbidity risks than the first CABG.

Only two small studies have compared DES versus BMS in saphenous vein graft lesions, and they had conflicting results. The larger ISAR-CABG is powered for clinical events.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of drug-eluting stents (Cypher, Taxus, and BP Sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up post percutaneous coronary intervention (PCI) for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Mean age was about 71.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, the saphenous vein graft was about 13.5 years old, and about 55% had a previous history of myocardial infarction. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts. TIMI flow rates pre- and post-PCI were similar between the two groups as well.

At 1 year, DES reduced the risk of the primary end point by 35%, compared with BMS, with rates of 15.4% and 22.1%, respectively, a significant difference. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or myocardial infarction were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

"Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients," Dr. Mehilli said.

Dr. Steven R. Bailey commented that, "This study was designed to answer appropriate questions." However, "It is surprising that there were so few females," added Dr. Bailey of the University of Texas Health Sciences Center, San Antonio.

He asked Dr. Mehilli if drug-eluting stents were compared with bare metal stents in subsets related to the complexity of saphenous vein graft lesions. She replied that a subgroup analysis of ISAR-CABG will be forthcoming.

Dr. Mehilli said that, in Germany, the overwhelming number of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli disclosed lecture fees from Abbott. Dr. Bailey has received consulting fees/honoraria from Volcano Corp.