多支血管病变患者冠状动脉搭桥手术与血管成形术的比较。

Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease.

出版信息

N Engl J Med. 1996 Jul 25;335(4):217-25. doi: 10.1056/NEJM199607253350401.

DOI:10.1056/NEJM199607253350401

Abstract

BACKGROUND

Coronary-artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA) are alternative methods of revascularization in patients with coronary artery disease. We tested the hypothesis that in selected patients with multivessel disease suitable for treatment with either procedure, an initial strategy of PTCA does not result in a poorer five-year clinical outcome than CABG.

METHODS

Patients with multivessel disease were randomly assigned to an initial treatment strategy of CABG (n = 914) or PTCA (n = 915) and were followed for an average of 5.4 years. Analysis of outcome events was performed according to the intention to treat.

RESULTS

The respective in-hospital event rates for CABG and PTCA were 1.3 percent and 1.1 percent for mortality, 4.6 percent and 2.1 percent for Q-wave myocardial infarction (P < 0.01), and 0.8 percent and 0.2 percent for stroke. The five-year survival rate was 89.3 percent for those assigned to CABG and 86.3 percent for those assigned to PTCA (P = 0.19; 95 percent confidence interval of the difference in survival, -0.2 percent to 6.0 percent). The respective five-year survival rates free from Q-wave myocardial infarction were 80.4 percent and 78.7 percent. By five years after study entry, 8 percent of the patients assigned to CABG had undergone additional revascularization procedures, as compared with 54 percent of those assigned to PTCA; 69 percent of those assigned to PTCA did not subsequently undergo CABG. Among diabetic patients who were being treated with insulin or oral hypoglycemic agents at base line, a subgroup not specified by the protocol, five-year survival was 80.6 percent for the CABG group as compared with 65.5 percent for the PTCA group (P = 0.003).

CONCLUSIONS

As compared with CABG, an initial strategy of PTCA did not significantly compromise five-year survival in patients with multivessel disease, although subsequent revascularization was required more often with this strategy. For treated diabetics, five-year survival was significantly better after CABG than after PTCA.

摘要

背景

冠状动脉旁路移植术（CABG）和经皮腔内冠状动脉成形术（PTCA）是冠心病患者血运重建的替代方法。我们检验了以下假设：在适合这两种手术治疗的多支血管病变患者中，PTCA初始策略导致的五年临床结局不比CABG差。

方法

将多支血管病变患者随机分配至CABG初始治疗策略组（n = 914）或PTCA组（n = 915），平均随访5.4年。根据意向性治疗进行结局事件分析。

结果

CABG和PTCA各自的院内死亡率分别为1.3%和1.1%，Q波心肌梗死发生率分别为4.6%和2.1%（P < 0.01），卒中发生率分别为0.8%和0.2%。分配至CABG组的患者五年生存率为89.3%，分配至PTCA组的患者为86.3%（P = 0.19；生存差异的95%置信区间为 -0.2%至6.0%）。无Q波心肌梗死的各自五年生存率分别为80.4%和78.7%。研究入组后五年时，分配至CABG组的患者中有8%接受了额外的血运重建手术，而分配至PTCA组的患者中这一比例为54%；分配至PTCA组的患者中有69%随后未接受CABG。在基线时接受胰岛素或口服降糖药治疗的糖尿病患者（方案未明确指定的一个亚组）中，CABG组的五年生存率为80.6%，而PTCA组为65.5%（P = 0.003）。