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初始冠状动脉支架植入术联合药物治疗与单纯药物治疗用于稳定型冠状动脉疾病:随机对照试验的荟萃分析

Initial coronary stent implantation with medical therapy vs medical therapy alone for stable coronary artery disease: meta-analysis of randomized controlled trials.

作者信息

Stergiopoulos Kathleen, Brown David L

机构信息

Division of Cardiovascular Medicine, Department of Medicine, State University of New York-Stony Brook School of Medicine, Health Sciences Center T16-080, Stony Brook, NY 11794.

出版信息

Arch Intern Med. 2012 Feb 27;172(4):312-9. doi: 10.1001/archinternmed.2011.1484.

Abstract

BACKGROUND

Prior meta-analyses have yielded conflicting results regarding the outcomes of treatment of stable coronary artery disease (CAD) with initial percutaneous coronary intervention (PCI) vs medical therapy. However, most of the studies in prior systematic reviews used balloon angioplasty as well as medical therapies that do not reflect current interventional or medical practices. We therefore performed a meta-analysis of all randomized clinical trials comparing initial coronary stent implantation with medical therapy to determine the effect on death, nonfatal myocardial infarction (MI), unplanned revascularization, and persistent angina.

METHODS

Prospective randomized trials were identified by searches of the MEDLINE database from 1970 to September 2011. Trials in which stents were used in less than 50% of PCI procedures were excluded. Data were extracted from each study, and summary odds ratios (ORs) were obtained using a random effects model.

RESULTS

Eight trials enrolling 7229 patients were identified. Three trials enrolled stable patients after MI, whereas 5 studies enrolled patients with stable angina and/or ischemia on stress testing. Mean weighted follow-up was 4.3 years. The respective event rates for death with stent implantation and medical therapy were 8.9% and 9.1% (OR, 0.98; 95% CI, 0.84-1.16); for nonfatal MI, 8.9% and 8.1% (OR, 1.12; 95% CI, 0.93-1.34); for unplanned revascularization, 21.4% and 30.7% (OR, 0.78; 95% CI, 0.57-1.06); and for persistent angina, 29% and 33% (OR, 0.80; 95% CI, 0.60-1.05).

CONCLUSION

Initial stent implantation for stable CAD shows no evidence of benefit compared with initial medical therapy for prevention of death, nonfatal MI, unplanned revascularization, or angina.

摘要

背景

既往的荟萃分析在稳定型冠状动脉疾病(CAD)初始经皮冠状动脉介入治疗(PCI)与药物治疗的结局方面得出了相互矛盾的结果。然而,既往系统评价中的大多数研究使用了球囊血管成形术以及不能反映当前介入或药物治疗实践的药物治疗方法。因此,我们对所有比较初始冠状动脉支架植入术与药物治疗的随机临床试验进行了荟萃分析,以确定其对死亡、非致命性心肌梗死(MI)、非计划血管重建和持续性心绞痛的影响。

方法

通过检索1970年至2011年9月的MEDLINE数据库确定前瞻性随机试验。PCI手术中使用支架少于50%的试验被排除。从每项研究中提取数据,并使用随机效应模型获得汇总比值比(OR)。

结果

共确定了8项试验,纳入7229例患者。3项试验纳入了心肌梗死后的稳定患者,而5项研究纳入了稳定型心绞痛和/或负荷试验有缺血的患者。平均加权随访时间为4.3年。支架植入组和药物治疗组的死亡事件发生率分别为8.9%和9.1%(OR,0.98;95%CI,0.84 - 1.16);非致命性心肌梗死发生率分别为8.9%和8.1%(OR,1.12;95%CI,0.93 - 1.34);非计划血管重建发生率分别为21.4%和30.7%(OR,0.78;95%CI,0.57 - 1.06);持续性心绞痛发生率分别为29%和33%(OR,0.80;95%CI,0.60 - 1.05)。

结论

对于稳定型CAD,与初始药物治疗相比,初始支架植入在预防死亡、非致命性心肌梗死、非计划血管重建或心绞痛方面没有显示出获益的证据。

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