Percutaneous Coronary Intervention versus Coronary-Artery Bypass Grafting for Severe Coronary Artery Disease
Percutaneous Coronary Intervention versus Coronary-Artery Bypass Grafting for Severe Coronary Artery Disease
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DOI：
10.1056/nejmoa0804626
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发表时间：
2009-03-05
影响因子：
158.5
通讯作者：
Mohr, Friedrich W.
中科院分区：
文献类型：
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作者：
Serruys, Patrick W.;Morice, Marie-Claude;Mohr, Friedrich W.
背景：尽管冠状动脉旁路移植术（CABG）历来是首选的治疗方法，但经皮冠状动脉介入治疗（PCI）包括药物洗脱支架越来越多地用于治疗复杂的冠状动脉疾病。我们的试验比较了PCI和CABG治疗先前未治疗的三支血管或左主干冠状动脉疾病（或两者）的患者。方法随机选择1800例三支或左主干冠状动脉病变患者行冠脉搭桥或PCI（比例为1:1）。对于所有这些患者，当地心脏外科医生和介入心脏病专家确定，两种治疗方法均可达到同等的解剖性血运重建术。对两组进行非劣效性比较，主要终点为随机分组后12个月内发生的主要心脑血管不良事件（即任何原因导致的死亡、中风、心肌梗死或重复血运重建术）。由于解剖特征或临床条件，两种治疗方案中只有一种对患者有益，将其输入平行嵌套的CABG或PCI登记。结果两组患者术前特征基本一致。PCI组12个月主要心脑血管不良事件发生率显著高于CABG组（17.8% vs 12.4%, P = 0.002），这在很大程度上是因为重复血运重建率增加（13.5% vs 5.9%, P = 0.002）
BackgroundPercutaneous coronary intervention (PCI) involving drug-eluting stents is increasingly used to treat complex coronary artery disease, although coronary-artery bypass grafting (CABG) has been the treatment of choice historically. Our trial compared PCI and CABG for treating patients with previously untreated three-vessel or left main coronary artery disease (or both).MethodsWe randomly assigned 1800 patients with three-vessel or left main coronary artery disease to undergo CABG or PCI (in a 1: 1 ratio). For all these patients, the local cardiac surgeon and interventional cardiologist determined that equivalent anatomical revascularization could be achieved with either treatment. A noninferiority comparison of the two groups was performed for the primary end point - a major adverse cardiac or cerebrovascular event (i.e., death from any cause, stroke, myocardial infarction, or repeat revascularization) during the 12-month period after randomization. Patients for whom only one of the two treatment options would be beneficial, because of anatomical features or clinical conditions, were entered into a parallel, nested CABG or PCI registry.ResultsMost of the preoperative characteristics were similar in the two groups. Rates of major adverse cardiac or cerebrovascular events at 12 months were significantly higher in the PCI group (17.8%, vs. 12.4% for CABG; P = 0.002), in large part because of an increased rate of repeat revascularization (13.5% vs. 5.9%, P