Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events
Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events
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DOI：
10.1056/nejmoa060989
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发表时间：
2006-04-20
影响因子：
158.5
通讯作者：
Yeoman, GD
中科院分区：
文献类型：
--
作者：
Bhatt, DL;Fox, KAA;Yeoman, GD
背景：氯吡格雷加低剂量阿司匹林的双重抗血小板治疗尚未在动脉粥样硬化血栓形成事件高危人群中进行研究。方法：我们将15，603例有临床明显心血管疾病或多种危险因素的患者随机分配接受氯吡格雷（75 mg/天）加低剂量阿司匹林（75 - 162 mg/天）或安慰剂加低剂量阿司匹林，并随访中位数为28个月。结果：氯吡格雷联合阿司匹林组的主要疗效终点发生率为6.8%，安慰剂联合阿司匹林组为7.3%（相对危险度为0.93; 95%可信区间为0.83 ~ 1.05; P=0.22）。主要次要疗效终点（包括因缺血事件住院）的发生率分别为16.7%和17.9%，（相对危险度为0.92; 95%可信区间为0.86 ~ 0.995; P=0.04），严重出血率分别为1.7%和1.3%。（相对危险度，1.25; 95%置信区间，0.97 - 1.61%; P=0.09）。在有多种危险因素的患者中，氯吡格雷组的主要终点发生率为6.6%，安慰剂组为5.5%（相对危险度为1.2; 95%置信区间为0.91 - 1.59; P=0.20），氯吡格雷组心血管原因死亡率也较高（3.9% vs. 2.2%，P=0.01）。在临床上有明显动脉粥样硬化血栓形成的亚组中，氯吡格雷组的发生率为6.9%，安慰剂组为7.9%（相对危险度为0.88; 95%可信区间为0.77 ~ 0.998; P=0.046）。结论：在本试验中，有迹象表明氯吡格雷治疗对有症状的动脉粥样硬化血栓形成患者有益，而对有多种危险因素的患者有害。总的来说，氯吡格雷联合阿司匹林在降低心肌梗死、中风或心血管原因死亡率方面并不比单独使用阿司匹林更有效。
BACKGROUND:Dual antiplatelet therapy with clopidogrel plus low-dose aspirin has not been studied in a broad population of patients at high risk for atherothrombotic events.METHODS:We randomly assigned 15,603 patients with either clinically evident cardiovascular disease or multiple risk factors to receive clopidogrel (75 mg per day) plus low-dose aspirin (75 to 162 mg per day) or placebo plus low-dose aspirin and followed them for a median of 28 months. The primary efficacy end point was a composite of myocardial infarction, stroke, or death from cardiovascular causes.RESULTS:The rate of the primary efficacy end point was 6.8 percent with clopidogrel plus aspirin and 7.3 percent with placebo plus aspirin (relative risk, 0.93; 95 percent confidence interval, 0.83 to 1.05; P=0.22). The respective rate of the principal secondary efficacy end point, which included hospitalizations for ischemic events, was 16.7 percent and 17.9 percent (relative risk, 0.92; 95 percent confidence interval, 0.86 to 0.995; P=0.04), and the rate of severe bleeding was 1.7 percent and 1.3 percent (relative risk, 1.25; 95 percent confidence interval, 0.97 to 1.61 percent; P=0.09). The rate of the primary end point among patients with multiple risk factors was 6.6 percent with clopidogrel and 5.5 percent with placebo (relative risk, 1.2; 95 percent confidence interval, 0.91 to 1.59; P=0.20) and the rate of death from cardiovascular causes also was higher with clopidogrel (3.9 percent vs. 2.2 percent, P=0.01). In the subgroup with clinically evident atherothrombosis, the rate was 6.9 percent with clopidogrel and 7.9 percent with placebo (relative risk, 0.88; 95 percent confidence interval, 0.77 to 0.998; P=0.046).CONCLUSIONS:In this trial, there was a suggestion of benefit with clopidogrel treatment in patients with symptomatic atherothrombosis and a suggestion of harm in patients with multiple risk factors. Overall, clopidogrel plus aspirin was not significantly more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes.