Heart Institute, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
N Engl J Med. 2011 May 5;364(18):1718-27. doi: 10.1056/NEJMoa1100452. Epub 2011 Apr 4.
Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice.
We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups.
The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P=0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P=0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P=0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P=0.02).
In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.).
经皮冠状动脉介入治疗（PCI）越来越多地用于治疗无保护左主干冠状动脉狭窄，尽管冠状动脉旁路移植术（CABG）一直被认为是首选治疗方法。
我们将患有无保护左主干冠状动脉狭窄的患者随机分为 CABG 组（300 例）或 PCI 组（300 例），使用非劣效性的宽边界，比较两组在 1 年时主要不良心脑血管事件（任何原因死亡、心肌梗死、卒中和缺血驱动的靶血管血运重建）的主要复合终点。两组在 2 年时的事件发生率也进行了比较。
与 CABG 组的 20 例患者相比，PCI 组发生主要终点事件的患者有 26 例（累积事件发生率为 8.7%比 6.7%；绝对风险差异为 2.0%；95%置信区间[CI]为-1.6 至 5.6；非劣效性 P=0.01）。到 2 年时，PCI 组中有 36 例患者发生主要终点事件，而 CABG 组有 24 例（累积事件发生率为 12.2%比 8.1%；PCI 组的危险比为 1.50；95%CI 为 0.90 至 2.52；P=0.12）。两组在 2 年时的死亡、心肌梗死或卒中等复合终点发生率分别为 13 例和 14 例（累积事件发生率分别为 4.4%和 4.7%；危险比为 0.92；95%CI 为 0.43 至 1.96；P=0.83）。在 PCI 组中有 26 例患者发生缺血驱动的靶血管血运重建，而 CABG 组中有 12 例（累积事件发生率分别为 9.0%和 4.2%；危险比为 2.18；95%CI 为 1.10 至 4.32；P=0.02）。
在这项涉及无保护左主干冠状动脉狭窄患者的随机试验中，与 CABG 相比，药物洗脱支架 PCI 治疗在主要心脑血管不良事件方面不劣效。然而，非劣效性边界较宽，结果不能被认为具有临床指导意义。（由韩国首尔心血管研究基金会等资助；PRECOMBAT ClinicalTrials.gov 编号，NCT00422968。）
