Sirolimus-eluting (2.6%) and everolimus-eluting (3.2%) stents showed no significant difference in cardiac death or MI at 2 years compared with bare-metal stents (4.8%) in large coronary arteries.
RCT (n=2,314)
Randomized
Do drug-eluting stents (sirolimus-eluting or everolimus-eluting) reduce death or myocardial infarction compared to bare-metal stents in patients requiring stenting of large coronary arteries (≥3.0 mm)?
In large coronary arteries (≥3.0 mm), drug-eluting stents did not significantly reduce death or MI compared to bare-metal stents, but significantly reduced target-vessel revascularization.
Absolute Event Rate: 2.6% vs 4.8%
BACKGROUND: Recent data have suggested that patients with coronary disease in large arteries are at increased risk for late cardiac events after percutaneous intervention with first-generation drug-eluting stents, as compared with bare-metal stents. We sought to confirm this observation and to assess whether this increase in risk was also seen with second-generation drug-eluting stents. METHODS: We randomly assigned 2314 patients needing stents that were 3.0 mm or more in diameter to receive sirolimus-eluting, everolimus-eluting, or bare-metal stents. The primary end point was the composite of death from cardiac causes or nonfatal myocardial infarction at 2 years. Late events (occurring during months 7 to 24) and target-vessel revascularization were the main secondary end points. RESULTS: The rates of the primary end point were 2.6% among patients receiving sirolimus-eluting stents, 3.2% among those receiving everolimus-eluting stents, and 4.8% among those receiving bare-metal stents, with no significant differences between patients receiving either drug-eluting stent and those receiving bare-metal stents. There were also no significant between-group differences in the rate of late events or in the rate of death, myocardial infarction, or stent thrombosis. Rates of target-vessel revascularization for reasons unrelated to myocardial infarction were 3.7% among patients receiving sirolimus-eluting stents, 3.1% among those receiving everolimus-eluting stents, and 8.9% among those receiving bare-metal stents. The rate of target-vessel revascularization was significantly reduced among patients receiving either drug-eluting stent, as compared with a bare-metal stent, with no significant difference between the two types of drug-eluting stents. CONCLUSIONS: In patients requiring stenting of large coronary arteries, no significant differences were found among sirolimus-eluting, everolimus-eluting, and bare-metal stents with respect to the rate of death or myocardial infarction. With the two drug-eluting stents, similar reductions in rates of target-vessel revascularization were seen. (Funded by the Basel Cardiovascular Research Foundation and the Swiss National Foundation for Research; Current Controlled Trials number, ISRCTN72444640.).
Kaiser et al. (2010) conducted an RCT in Coronary disease in large arteries (n=2,314). Sirolimus-eluting or everolimus-eluting stents vs. Bare-metal stents was evaluated on Composite of death from cardiac causes or nonfatal myocardial infarction at 2 years. Sirolimus-eluting (2.6%) and everolimus-eluting (3.2%) stents showed no significant difference in cardiac death or MI at 2 years compared with bare-metal stents (4.8%) in large coronary arteries.