Serruys Patrick W, Morice Marie-Claude, Kappetein A Pieter, Colombo Antonio, Holmes David R, Mack Michael J, Ståhle Elisabeth, Feldman Ted E, van den Brand Marcel, Bass Eric J, Van Dyck Nic, Leadley Katrin, Dawkins Keith D, Mohr Friedrich W
Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.
N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.
BACKGROUND: Percutaneous 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). METHODS: We 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. RESULTS: Most 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<0.001); as a result, the criterion for noninferiority was not met. At 12 months, the rates of death and myocardial infarction were similar between the two groups; stroke was significantly more likely to occur with CABG (2.2%, vs. 0.6% with PCI; P=0.003). CONCLUSIONS: CABG remains the standard of care for patients with three-vessel or left main coronary artery disease, since the use of CABG, as compared with PCI, resulted in lower rates of the combined end point of major adverse cardiac or cerebrovascular events at 1 year. (ClinicalTrials.gov number, NCT00114972.)
背景：尽管冠状动脉旁路移植术（CABG）历来是首选治疗方法，但涉及药物洗脱支架的经皮冠状动脉介入治疗（PCI）越来越多地用于治疗复杂冠状动脉疾病。我们的试验比较了PCI和CABG治疗既往未经治疗的三支血管病变或左主干冠状动脉疾病（或两者兼有）患者的疗效。 方法：我们将1800例三支血管病变或左主干冠状动脉疾病患者随机分配接受CABG或PCI（1:1比例）。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均可实现等效的解剖学血运重建。对两组进行非劣效性比较，以主要终点——随机分组后12个月内发生的主要不良心脏或脑血管事件（即任何原因导致的死亡、中风、心肌梗死或再次血运重建）作为指标。由于解剖特征或临床情况，仅两种治疗选择之一有益的患者被纳入平行的、嵌套的CABG或PCI登记系统。 结果：两组患者术前的大多数特征相似。PCI组12个月时主要不良心脏或脑血管事件发生率显著高于CABG组（17.8%，CABG组为12.4%；P=0.002），很大程度上是因为再次血运重建率增加（13.5%对5.9%，P<0.001）；因此，未达到非劣效性标准。12个月时，两组的死亡率和心肌梗死发生率相似；CABG组发生中风的可能性显著更高（2.2%，PCI组为0.6%；P=0.003）。 结论：CABG仍然是三支血管病变或左主干冠状动脉疾病患者的治疗标准，因为与PCI相比，使用CABG在1年时主要不良心脏或脑血管事件的联合终点发生率更低。（ClinicalTrials.gov编号，NCT00114972。）
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