Optimal medical therapy with or without PCI for stable coronary disease
Optimal medical therapy with or without PCI for stable coronary disease
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DOI：
10.1056/nejmoa070829
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发表时间：
2007-04-12
影响因子：
158.5
通讯作者：
Mathien, J.
中科院分区：
文献类型：
--
作者：
Boden, William E.;O'Rourke, Robert A.;Mathien, J.
背景资料：在稳定型冠心病患者中，经皮冠状动脉介入治疗（PCI）联合强化药物治疗和生活方式干预的初始管理策略（最佳药物治疗）在降低心血管事件风险方面上级单独的最佳药物治疗。我们在美国和加拿大的50个中心进行了一项随机试验，涉及2287例有心肌缺血和严重冠状动脉疾病客观证据的患者。1999年至2004年间，我们分配了1149名患者接受最佳药物治疗的PCI（PCI组），1138名患者单独接受最佳药物治疗（药物治疗组）。主要结果是在2.5 - 7.0年的随访期内（中位数4.6年）任何原因导致的死亡和非致命性心肌梗死。结果：PCI组有211起主要事件，药物治疗组有202起事件。PCI组4.6年累积主要事件发生率为19.0%，药物治疗组为18.5%（PCI组的风险比为1.05; 95%可信区间[CI]为0.87 ~ 1.27; P=0.62）。PCI组和药物治疗组在死亡、心肌梗死和卒中的复合事件方面没有显著差异（20.0% vs. 19.5%;风险比，1.05; 95% CI，0.87 - 1.27; P=0.62）;因急性冠脉综合征住院（12.4% vs. 11.8%;风险比，1.07; 95% CI，0.84 - 1.37; P=0.56）;或心肌梗死（13.2% vs. 12.3%;风险比，1.13; 95% CI，0.89至1.43; P=0.33）。PCI作为稳定型冠状动脉疾病患者的初始管理策略，在最佳药物治疗的基础上进行PCI并不能降低死亡、心肌梗死或其他主要心血管事件的风险。
Background: In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events.Methods: We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6).Results: There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33).Conclusions: As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.