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对于稳定型心绞痛或急性冠状动脉综合征患者,经皮冠状动脉腔内血管成形术加支架置入术与冠状动脉旁路移植术的比较。

Percutaneous transluminal coronary angioplasty with stents versus coronary artery bypass grafting for people with stable angina or acute coronary syndromes.

作者信息

Bakhai A, Hill R A, Dundar Y, Dickson R, Walley T

出版信息

Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD004588. doi: 10.1002/14651858.CD004588.pub3.

Abstract

BACKGROUND

Coronary artery bypass graft surgery (CABG) replaces obstructed vessels with ones from other parts of the body. Alternatively, obstructions are remodelled using catheter-based techniques such as percutaneous coronary angioplasty with the use of stents. Though less invasive, stenting techniques are limited by the re-narrowing of treated vessels (restenosis). We examined evidence on cardiac-related outcomes occurring after CABG or stenting, with implications for resource use, resource allocation and informing patient choice.

OBJECTIVES

To examine evidence from randomised controlled trials (RCTs) on benefit of stents or CABG in reducing cardiac events in people with stable angina or acute coronary syndrome (ACS).

SEARCH STRATEGY

CENTRAL (Issue 2 2004), EMBASE (1990 to 2004), MEDLINE (1990 to 2004) and handsearching to July 2004.

SELECTION CRITERIA

Only RCTs comparing stents used with PTCA with CABG were included. Participants were adults with stable angina or ACS and unstable angina and had either single or multiple vessel disease. Published and unpublished sources were considered.

DATA COLLECTION AND ANALYSIS

Outcomes included composite event rate (major adverse cardiac event, event free survival), death, acute myocardial infarction (AMI), repeat revascularisation and binary restenosis as well as information on design and baseline characteristics. Quality assessment was completed independently. Meta-analyses are presented as odds ratios, 95% confidence intervals (CI) using a fixed-effect model. Heterogeneity between trials was assessed.

MAIN RESULTS

Nine studies (3519 patients) were included. Four RCTs included patients with multiple vessel disease, five focused on single vessel disease. Four studies reported beyond 1 year. No statistical differences were observed between CABG and stenting for meta-analysis of mortality or AMI, but there was heterogeneity. Composite cardiac event and revascularisation rates were lower for CABG than for stents. Odds ratios resulting from meta-analysis of event rate data at 1 year were, odds ratio 0.43 (95% CI 0.35 to 0.54) and at 3 years, odds ratio 0.37 (95% CI 0.29 to 0.48). Odds ratios for revascularisation at 1 year were, odds ratio 0.18 (95% CI 0.13 to 0.25) and at 3 years, odds ratio 0.09 (95% CI 0.02 to 0.34). Binary restenosis at 6 months (single vessel trials) favoured CABG, odds ratio 0.29 (95% CI 0.17 to 0.51).

AUTHORS' CONCLUSIONS: CABG is associated with reduced rates of major adverse cardiac events, mostly driven by reduced repeat revascularisation. However, the RCT data are limited by follow-up, unrepresentative samples and rapid development of both surgical techniques and stenting. Research on real-world patient population or patient level data meta-analyses may identify risk factors and groupings who may benefit most from one strategy over the other.

摘要

背景

冠状动脉旁路移植术(CABG)使用来自身体其他部位的血管替换阻塞的血管。或者,使用基于导管的技术(如使用支架的经皮冠状动脉血管成形术)对阻塞进行重塑。尽管侵入性较小,但支架技术受到治疗血管再狭窄( restenosis)的限制。我们研究了冠状动脉旁路移植术或支架置入术后发生的与心脏相关结局的证据,这些证据对资源使用、资源分配以及告知患者选择具有重要意义。

目的

研究随机对照试验(RCT)中关于支架或冠状动脉旁路移植术在降低稳定型心绞痛或急性冠状动脉综合征(ACS)患者心脏事件方面的益处的证据。

检索策略

检索Cochrane系统评价数据库(CENTRAL,2004年第2期)、EMBASE数据库(1990年至2004年)、MEDLINE数据库(1990年至2004年),并进行手工检索至2004年7月。

选择标准

仅纳入比较使用支架的经皮冠状动脉腔内血管成形术(PTCA)与冠状动脉旁路移植术的随机对照试验。参与者为患有稳定型心绞痛或急性冠状动脉综合征以及不稳定型心绞痛的成年人,且患有单支或多支血管病变。考虑已发表和未发表的资料来源。

数据收集与分析

结局包括复合事件发生率(主要不良心脏事件、无事件生存)、死亡、急性心肌梗死(AMI)、再次血运重建和二元再狭窄,以及关于设计和基线特征的信息。质量评估由独立完成。荟萃分析以比值比、95%置信区间(CI)的形式呈现,使用固定效应模型。评估试验之间的异质性。

主要结果

纳入9项研究(3519例患者)。4项随机对照试验纳入了多支血管病变患者,5项聚焦于单支血管病变。4项研究随访超过1年。在荟萃分析死亡率或急性心肌梗死时,冠状动脉旁路移植术和支架置入术之间未观察到统计学差异,但存在异质性。冠状动脉旁路移植术的复合心脏事件和血运重建率低于支架置入术。1年时事件发生率数据荟萃分析得出的比值比为0.43(95%CI 0.35至0.54),3年时为0.37(95%CI 0.29至0.48)。1年时血运重建的比值比为0.18(95%CI 0.13至0.25),3年时为0.09(95%CI 0.02至0.34)。6个月时(单支血管试验)二元再狭窄有利于冠状动脉旁路移植术,比值比为0.29(95%CI 0.17至0.51)。

作者结论

冠状动脉旁路移植术与主要不良心脏事件发生率降低相关,这主要是由于再次血运重建减少所致。然而,随机对照试验数据受到随访、无代表性样本以及手术技术和支架置入术快速发展的限制。对真实世界患者群体或患者层面数据的荟萃分析可能会确定哪些危险因素和分组可能从一种策略中比从另一种策略中获益更多。

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