Drug-Eluting versus Bare-Metal Stents in Large Coronary Arteries
Drug-Eluting versus Bare-Metal Stents in Large Coronary Arteries
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DOI：
10.1056/nejmoa1009406
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发表时间：
2010-12-09
影响因子：
158.5
通讯作者：
Pfisterer, Matthias
中科院分区：
文献类型：
--
作者：
Kaiser, Christoph;Galatius, Soeren;Pfisterer, Matthias
背景最近的数据表明，与裸金属支架相比，使用第一代药物洗脱支架进行经皮介入治疗后，大动脉冠状动脉疾病患者发生晚期心脏事件的风险增加。我们试图证实这一观察结果，并评估这种风险增加是否也出现在第二代药物洗脱支架中。方法我们随机分配2314名需要直径3.0 mm或更大支架的患者接受西罗莫司洗脱支架、伊波利莫斯洗脱支架或裸金属支架。主要终点是2年后因心脏原因死亡或非致命性心肌梗死的综合结果。晚期事件(发生在7~24个月)和靶血管重建是主要的次要终点。结果接受西罗莫司洗脱支架的患者的主要终点发生率为2.6%，接受伊罗莫司洗脱支架的患者为3.2%，接受裸金属支架的患者为4.8%，接受药物洗脱支架的患者和接受裸金属支架的患者之间没有显著差异。在晚期事件发生率或死亡率、心肌梗死或支架血栓形成方面，两组间也没有显著差异。在接受西罗莫司洗脱支架的患者中，由于与心肌梗死无关的原因而进行靶血管重建率为3.7%，在接受伊罗莫司洗脱支架的患者中为3.1%，在接受裸金属支架的患者中为8.9%。与裸金属支架相比，接受药物洗脱支架的患者靶血管重建率显著降低，两种类型的药物洗脱支架之间没有显著差异。结论在需要植入大冠状动脉支架的患者中，西罗莫司洗脱支架、维罗莫司洗脱支架和裸金属支架在死亡率和心肌梗死方面没有显著差异。使用两种药物洗脱支架，靶血管再血管重建率也有类似的降低。
BACKGROUNDRecent 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.METHODSWe 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.RESULTSThe 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.CONCLUSIONSIn 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.