King S B, Lembo N J, Weintraub W S, Kosinski A S, Barnhart H X, Kutner M H, Alazraki N P, Guyton R A, Zhao X Q
Division of Cardiology, Emory University School of Medicine, Atlanta, GA.
N Engl J Med. 1994 Oct 20;331(16):1044-50. doi: 10.1056/NEJM199410203311602.
The clinical benefit of percutaneous transluminal coronary angioplasty (PTCA) as compared with coronary-artery bypass grafting (CABG) for patients with multivessel coronary artery disease has not been established. To determine the outcomes of these treatments in patients referred for the first time for coronary revascularization, we conducted a three-year prospective, randomized trial comparing the two procedures.
Revascularization was performed by accepted methods. Follow-up clinical information was collected every six months, and coronary arteriography and thallium stress scanning were performed at one and three years. The primary end point was a composite of death, Q-wave myocardial infarction, and a large ischemic defect identified on thallium scanning at three years. Secondary end points included clinical and angiographic status and the need for additional revascularization procedures. Data were analyzed according to the intention-to-treat principle.
Of the 5118 patients screened for the trial, 842 (16.5 percent) were eligible for enrollment, and 392 (7.7 percent) agreed to participate. A total of 194 patients were randomly assigned to the CABG group, and 198 to the PTCA group. The primary end point occurred in 27.3 percent of the CABG group and 28.8 percent of the PTCA group (P = 0.81). Death occurred in 6.2 percent of the CABG group and 7.1 percent of the PTCA group (P = 0.73 by log-rank test). At three years, the proportions of patients in the CABG group who required repeated bypass surgery (1 percent) or angioplasty (13 percent) were significantly lower than the proportions in the PTCA group (22 and 41 percent, respectively; P < 0.001). Angiographic studies at three years showed a greater degree of revascularization in the CABG group. Angina was more frequent in the PTCA group (20 percent) than in the CABG group (12 percent).
We found that CABG and PTCA did not differ significantly with respect to the occurrence of the composite primary end point. Consequently, the selection of one procedure over the other should be guided by patients' preferences regarding the quality of life and the possible need for subsequent procedures.
对于多支冠状动脉疾病患者，经皮腔内冠状动脉成形术（PTCA）与冠状动脉旁路移植术（CABG）相比的临床益处尚未明确。为了确定首次接受冠状动脉血运重建治疗的患者接受这些治疗的结果，我们进行了一项为期三年的前瞻性随机试验，比较这两种手术。
采用公认的方法进行血运重建。每六个月收集一次随访临床信息，并在一年和三年时进行冠状动脉造影和铊负荷扫描。主要终点是三年时死亡、Q波心肌梗死以及铊扫描显示的大面积缺血缺损的综合结果。次要终点包括临床和血管造影状况以及是否需要额外的血运重建手术。根据意向性分析原则对数据进行分析。
在筛选参加试验的5118例患者中，842例（16.5%）符合入选条件，392例（7.7%）同意参与。共有194例患者被随机分配至CABG组，198例被分配至PTCA组。主要终点在CABG组的发生率为27.3%，在PTCA组为28.8%（P = 0.81）。CABG组的死亡率为6.2%，PTCA组为7.1%（对数秩检验P = 0.73）。三年时，CABG组需要再次进行搭桥手术（1%）或血管成形术（13%）的患者比例显著低于PTCA组（分别为22%和41%；P < 0.001）。三年时的血管造影研究显示CABG组的血运重建程度更高。PTCA组（20%）的心绞痛发生率高于CABG组（12%）。
我们发现，在综合主要终点的发生方面，CABG和PTCA没有显著差异。因此，在选择这两种手术时，应根据患者对生活质量的偏好以及后续手术的可能需求来指导。
