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最佳药物治疗联合或不联合经皮冠状动脉介入治疗对稳定型冠状动脉疾病患者长期心血管终点的影响(来自COURAGE试验)

Impact of optimal medical therapy with or without percutaneous coronary intervention on long-term cardiovascular end points in patients with stable coronary artery disease (from the COURAGE Trial).

作者信息

Boden William E, O'Rourke Robert A, Teo Koon K, Maron David J, Hartigan Pamela M, Sedlis Steven P, Dada Marcin, Labedi Mohammed, Spertus John A, Kostuk William J, Berman Daniel S, Shaw Leslee J, Chaitman Bernard R, Mancini G B John, Weintraub William S

机构信息

VA Western New York Health Care System, Buffalo General Hospital, and the University at Buffalo, Buffalo, NY, USA.

出版信息

Am J Cardiol. 2009 Jul 1;104(1):1-4. doi: 10.1016/j.amjcard.2009.02.059. Epub 2009 Apr 16.

Abstract

The main results of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial revealed no significant differences in the primary end point of all-cause mortality or nonfatal myocardial infarction [MI] or major secondary end points (composites of death/MI/stroke; hospitalization for acute coronary syndromes [ACSs]) during a median 4.6-year follow-up in 2,287 patients with stable coronary artery disease randomized to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). We sought to assess the impact of PCI when added to OMT on major prespecified tertiary cardiovascular outcomes (time to first event), namely cardiac death and composites of cardiac death/MI, cardiac death/MI/hospitalization for ACS, cardiac death/MI/stroke, MI/stroke, or cardiac death/MI/ACS/stroke, during study follow-up. There were no significant differences between treatment arms for the composite of cardiac death or MI (15% in PCI + OMT group vs 14.2% in OMT group, hazard ratio 1.07, 95% confidence interval 0.86 to 1.33, p = 0.62) or in any of the major prespecified composite cardiovascular events during long-term follow-up, even after excluding periprocedural MI as an outcome of interest. Overall, cause-specific cardiovascular outcomes paralleled closely the primary and secondary composite outcomes of the trial as a whole. In conclusion, compared with an initial management strategy of OMT alone, addition of PCI did not decrease the incidence of major cardiovascular outcomes including cardiac death or the composite of cardiac death/MI/ACS/stroke in patients with stable coronary artery disease.

摘要

利用血运重建和积极药物评估(COURAGE)试验的主要结果显示,在2287例稳定型冠状动脉疾病患者中,随机接受最佳药物治疗(OMT)加或不加经皮冠状动脉介入治疗(PCI),在中位4.6年的随访期间,全因死亡率、非致死性心肌梗死(MI)或主要次要终点(死亡/MI/卒中的复合终点;急性冠状动脉综合征(ACS)住院)方面无显著差异。我们试图评估在OMT基础上加用PCI对主要预先指定的三级心血管结局(首次事件发生时间)的影响,即心源性死亡以及心源性死亡/MI、心源性死亡/MI/ACS住院、心源性死亡/MI/卒中、MI/卒中或心源性死亡/MI/ACS/卒中的复合终点,在研究随访期间。在随访期间,PCI加OMT组的心源性死亡或MI复合终点(PCI + OMT组为15%,OMT组为14.2%,风险比1.07,95%置信区间0.86至1.33,p = 0.62)与OMT组之间无显著差异,在排除围手术期MI作为感兴趣的结局后,在任何主要预先指定的复合心血管事件中也无显著差异。总体而言,特定病因的心血管结局与整个试验的主要和次要复合结局密切平行。总之,与单独使用OMT的初始管理策略相比,在稳定型冠状动脉疾病患者中加用PCI并未降低包括心源性死亡或心源性死亡/MI/ACS/卒中复合终点在内的主要心血管结局的发生率。

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