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冠状动脉球囊血管成形术与搭桥血运重建术对比研究(CABRI)的首年结果。CABRI试验参与者。

First-year results of CABRI (Coronary Angioplasty versus Bypass Revascularisation Investigation). CABRI Trial Participants.

出版信息

Lancet. 1995 Nov 4;346(8984):1179-84.

PMID:7475656
Abstract

The Coronary Angioplasty versus Bypass Revascularisation Investigation (CABRI) is a multinational, multicentre randomised trial comparing the strategies of revascularisation by CABG (coronary artery bypass grafting) and PTCA (percutaneous transluminal coronary angioplasty) in patients with symptomatic multivessel coronary disease. 1054 patients (820 men and 234 women) were recruited from 26 European cardiac centres. The average age was 60 years and 62% presented with angina of class 3 or greater. 513 patients were randomised to CABG and 541 to PTCA, and 93% and 96%, respectively, of those randomised underwent the allocated procedure. This first report presents data analysed by intention to treat and documents all deaths, major cardiac events, and the symptom status of the patients 1 year after randomisation. After 1 year of follow-up, 14 (2.7%) of those randomised to CABG and 21 (3.9%) of those randomised to PTCA had died. The PTCA group's relative risk (RR) of death was 1.42 (95% CI 0.73-2.76). Patients randomised to PTCA required significantly more reinterventions; only 66.4% reached 1 year with a single revascularisation procedure compared with 93.5% of patients randomised to CABG (RR = 5.23 [3.90-7.03], p < 0.001). The patients in the PTCA group took significantly more medication at 1 year (RR = 1.30 [1.18-1.43], p < 0.001). They were also more likely to have clinically significant angina (RR = 1.54 [1.09-2.16], p = 0.012); this association was present in both sexes but was significant only in females. CABRI is the largest trial of CABG versus PTCA to be reported so far. Its findings are consistent with previous studies, and add to the weight of information that clinicians need to discuss with patients when options for the management of severe angina are under consideration.

摘要

冠状动脉成形术与搭桥血运重建术研究(CABRI)是一项跨国、多中心随机试验,比较了冠状动脉旁路移植术(CABG)和经皮腔内冠状动脉成形术(PTCA)对有症状多支冠状动脉疾病患者进行血运重建的策略。从26个欧洲心脏中心招募了1054例患者(820例男性和234例女性)。平均年龄为60岁,62%的患者表现为3级或更严重的心绞痛。513例患者被随机分配至CABG组,541例被随机分配至PTCA组,分别有93%和96%的随机分组患者接受了分配的手术。本首次报告呈现了按意向性治疗分析的数据,并记录了随机分组后1年时所有患者的死亡情况、主要心脏事件和症状状态。随访1年后,随机分配至CABG组的患者中有14例(2.7%)死亡,随机分配至PTCA组的患者中有21例(3.9%)死亡。PTCA组的死亡相对风险(RR)为1.42(95%可信区间0.73 - 2.76)。随机分配至PTCA组的患者需要更多的再次干预;只有66.4%的患者通过单次血运重建手术达到1年,而随机分配至CABG组的患者这一比例为93.5%(RR = 5.23 [3.90 - 7.03],p < 0.001)。PTCA组患者在1年时服用的药物显著更多(RR = 1.30 [1.18 - 1.43],p < 0.001)。他们也更有可能出现具有临床意义的心绞痛(RR = 1.54 [1.09 - 2.16],p = 0.012);这种关联在男女两性中均存在,但仅在女性中具有显著性。CABRI是迄今为止报告的关于CABG与PTCA对比的最大规模试验。其研究结果与先前的研究一致,并增加了临床医生在考虑严重心绞痛治疗方案时需要与患者讨论的信息量。

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