氯吡格雷联合阿司匹林对非ST段抬高急性冠脉综合征患者的影响。

Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation.

作者信息

Yusuf S, Zhao F, Mehta S R, Chrolavicius S, Tognoni G, Fox K K

出版信息

N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746.

DOI:10.1056/NEJMoa010746

PMID:11519503

Abstract

BACKGROUND

Despite current treatments, patients who have acute coronary syndromes without ST-segment elevation have high rates of major vascular events. We evaluated the efficacy and safety of the antiplatelet agent clopidogrel when given with aspirin in such patients.

METHODS

We randomly assigned 12,562 patients who had presented within 24 hours after the onset of symptoms to receive clopidogrel (300 mg immediately, followed by 75 mg once daily) (6259 patients) or placebo (6303 patients) in addition to aspirin for 3 to 12 months.

RESULTS

The first primary outcome--a composite of death from cardiovascular causes, nonfatal myocardial infarction, or stroke--occurred in 9.3 percent of the patients in the clopidogrel group and 11.4 percent of the patients in the placebo group (relative risk with clopidogrel as compared with placebo, 0.80; 95 percent confidence interval, 0.72 to 0.90; P<0.001). The second primary outcome--the first primary outcome or refractory ischemia--occurred in 16.5 percent of the patients in the clopidogrel group and 18.8 percent of the patients in the placebo group (relative risk, 0.86; 95 percent confidence interval, 0.79 to 0.94; P<0.001). The percentages of patients with in-hospital refractory or severe ischemia, heart failure, and revascularization procedures were also significantly lower with clopidogrel. There were significantly more patients with major bleeding in the clopidogrel group than in the placebo group (3.7 percent vs. 2.7 percent; relative risk, 1.38; P=0.001), but there were not significantly more patients with episodes of life-threatening bleeding (2.2 percent [corrected] vs. 1.8 percent; P=0.13) or hemorrhagic strokes (0.1 percent vs. 0.1 percent).

CONCLUSIONS

The antiplatelet agent clopidogrel has beneficial effects in patients with acute coronary syndromes without ST-segment elevation. However, the risk of major bleeding is increased among patients treated with clopidogrel.

摘要

背景

尽管有当前的治疗方法，但非ST段抬高型急性冠脉综合征患者发生主要血管事件的几率仍很高。我们评估了抗血小板药物氯吡格雷与阿司匹林联合应用于此类患者的疗效和安全性。

方法

我们将12562例在症状发作后24小时内就诊的患者随机分组，其中6259例患者接受氯吡格雷（立即给予300mg，随后每日1次75mg），6303例患者接受安慰剂，两组均联合阿司匹林治疗3至12个月。

结果

第一个主要结局——心血管原因死亡、非致死性心肌梗死或卒中的复合终点——在氯吡格雷组9.3%的患者中出现，在安慰剂组11.4%的患者中出现（氯吡格雷与安慰剂相比的相对风险为0.80；95%置信区间为0.72至0.90；P<0.001）。第二个主要结局——第一个主要结局或难治性缺血——在氯吡格雷组16.5%的患者中出现，在安慰剂组18.8%的患者中出现（相对风险为0.86；95%置信区间为0.79至0.94；P<0.001）。氯吡格雷治疗的患者中，院内难治性或严重缺血、心力衰竭以及血运重建治疗的患者比例也显著更低。氯吡格雷组发生大出血的患者明显多于安慰剂组（3.7%对2.7%；相对风险为1.38；P=0.001），但危及生命的出血事件（校正后为2.2%对1.8%；P=0.13）或出血性卒中（0.1%对0.1%）的患者数量并无显著差异。