Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes
Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes
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DOI：
10.1056/nejmoa0909475
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发表时间：
2010-09-02
影响因子：
158.5
通讯作者：
Yusuf, Salim
中科院分区：
文献类型：
--
作者：
Mehta, Shamir R.;Bassand, Jean-Pierre;Yusuf, Salim
研究背景氯吡格雷和阿司匹林被广泛用于急性冠脉综合征患者和接受经皮冠状动脉介入治疗（PCI）的患者。方法我们采用2 × 2析因设计，将25，086例急性冠脉综合征患者随机分为两组，（第1天600-mg负荷剂量，随后每天150 mg，持续6天，此后每天75 mg）或标准剂量氯吡格雷（300 mg负荷剂量，此后每日75 mg）和高剂量阿司匹林（每日300至325 mg）或低剂量阿司匹林（每日75至100 mg）。主要转归是30天时的心血管死亡、心肌梗死或卒中。结果：双倍剂量氯吡格雷组的主要转归发生率为4.2%，而标准剂量氯吡格雷组为4.4%（风险比为0.94; 95%可信区间[CI]为0.83 ~ 1.06; P = 0.30）。双倍剂量组和标准剂量组分别有2.5%和2.0%的患者发生大出血（风险比，1.24; 95% CI，1.05 - 1.46; P = 0.01）。在17，263例接受PCI的患者中，双倍剂量氯吡格雷与支架内血栓形成的次要结局显著降低相关（1.6% vs. 2.3%;风险比，0.68; 95%CI，0.55 - 0.85; P = 0.001）。高剂量和低剂量阿司匹林在主要结局方面没有显著差异（4.2% vs. 4.4%;风险比，0.97; 95% CI，0.86 - 1.09; P = 0.61）或大出血（2.3% vs. 2.3%;风险比，0.99; 95% CI，0.84 - 1.17; P = 0.90）。结论：在接受侵入性治疗的急性冠脉综合征患者中，7天双倍剂量氯吡格雷方案与标准剂量方案之间无显著差异，或在高剂量阿司匹林和低剂量阿司匹林之间，就心血管死亡、心肌梗死或卒中的主要结局而言。
BACKGROUNDClopidogrel and aspirin are widely used for patients with acute coronary syndromes and those undergoing percutaneous coronary intervention (PCI). However, evidence-based guidelines for dosing have not been established for either agent.METHODSWe randomly assigned, in a 2-by-2 factorial design, 25,086 patients with an acute coronary syndrome who were referred for an invasive strategy to either double-dose clopidogrel (a 600-mg loading dose on day 1, followed by 150 mg daily for 6 days and 75 mg daily thereafter) or standard-dose clopidogrel (a 300-mg loading dose and 75 mg daily thereafter) and either higher-dose aspirin (300 to 325 mg daily) or lower-dose aspirin (75 to 100 mg daily). The primary outcome was cardiovascular death, myocardial infarction, or stroke at 30 days.RESULTSThe primary outcome occurred in 4.2% of patients assigned to double-dose clopidogrel as compared with 4.4% assigned to standard-dose clopidogrel (hazard ratio, 0.94; 95% confidence interval [CI], 0.83 to 1.06; P = 0.30). Major bleeding occurred in 2.5% of patients in the double-dose group and in 2.0% in the standard-dose group (hazard ratio, 1.24; 95% CI, 1.05 to 1.46; P = 0.01). Double-dose clopidogrel was associated with a significant reduction in the secondary outcome of stent thrombosis among the 17,263 patients who underwent PCI (1.6% vs. 2.3%; hazard ratio, 0.68; 95% CI, 0.55 to 0.85; P = 0.001). There was no significant difference between higher-dose and lower-dose aspirin with respect to the primary outcome (4.2% vs. 4.4%; hazard ratio, 0.97; 95% CI, 0.86 to 1.09; P = 0.61) or major bleeding (2.3% vs. 2.3%; hazard ratio, 0.99; 95% CI, 0.84 to 1.17; P = 0.90).CONCLUSIONSIn patients with an acute coronary syndrome who were referred for an invasive strategy, there was no significant difference between a 7-day, double-dose clopidogrel regimen and the standard-dose regimen, or between higher-dose aspirin and lower-dose aspirin, with respect to the primary outcome of cardiovascular death, myocardial infarction, or stroke.