Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial
Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial
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DOI：
10.1016/s0140-6736(04)16721-4
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发表时间：
2004-07-24
期刊：
影响因子：
168.9
通讯作者：
Rupprecht, HJ
中科院分区：
文献类型：
--
作者：
Diener, HC;Bogousslavsky, J;Rupprecht, HJ
背景
在CAPRIE研究中，氯吡格雷在有动脉粥样硬化血栓形成疾病既往表现的患者中优于阿司匹林，并且在一些高危患者亚组中其益处更为显著。我们旨在评估在氯吡格雷基础上加用阿司匹林在预防血管事件方面是否比单用氯吡格雷有更大益处，同时评估潜在的出血风险是否更高。
方法
我们进行了一项随机、双盲、安慰剂对照试验，在7599名近期有缺血性脑卒中或短暂性脑缺血发作且至少有一个其他血管危险因素并且已经在接受每日75mg氯吡格雷治疗的高危患者中，比较阿司匹林（75mg/天）和安慰剂。治疗和随访时间为18个月。主要终点是缺血性脑卒中、心肌梗死、血管性死亡或因急性缺血再次住院（包括因短暂性脑缺血发作、心绞痛或外周动脉疾病恶化再次住院）的复合终点。采用意向性治疗分析，使用对数秩检验和Cox比例风险模型。
结果
在接受阿司匹林和氯吡格雷治疗的组中，有596名（15.7%）患者达到主要终点，而在单用氯吡格雷组中有636名（16.7%）患者达到主要终点（相对风险降低6.4%，[95%置信区间 -4.6至16.3]；绝对风险降低1%[0.6至2.7]）。接受阿司匹林和氯吡格雷治疗组危及生命的出血发生率高于单用氯吡格雷组（96名[2.6%]对49名[1.3%]；绝对风险增加1.3%[95%置信区间0.6至1.9]）。接受阿司匹林和氯吡格雷治疗组的严重出血也有所增加，但死亡率无差异。
解释
在近期有缺血性脑卒中或短暂性脑缺血发作的高危患者中，在氯吡格雷基础上加用阿司匹林在减少主要血管事件方面差异无统计学意义。然而，加用阿司匹林会增加危及生命或严重出血的风险。
Background Clopidogrel was superior to aspirin in patients with previous manifestations of atherothrombotic disease in the CAPRIE study and its benefit was amplified in some high-risk subgroups of patients. We aimed to assess whether addition of aspirin to clopidogrel could have a greater benefit than clopidogrel alone in prevention of vascular events with potentially higher bleeding risk.Methods We did a randomised, double-blind, placebo-controlled trial to compare aspirin (75 mg/day) with placebo in 7599 high-risk patients with recent ischaemic stroke or transient ischaemic attack and at least one additional vascular risk factor who were already receiving clopidogrel 75 mg/day. Duration of treatment and follow-up was 18 months. The primary endpoint was a composite of ischaemic stroke, myocardial infarction, vascular death, or rehospitalisation for acute ischaemia (including rehospitalisation for transient ischaemic attack, angina pectoris, or worsening of peripheral arterial disease). Analysis was by intention to treat, using logrank test and a Cox's proportional-hazards model.Findings 596 (15.7%) patients reached the primary endpoint in the group receiving aspirin and clopidogrel compared with 636 (16.7%) in the clopidogrel alone group (relative risk reduction 6.4%, [95% CI-4.6 to 16.3]; absolute risk reduction 1% [0.6 to 2.7]). Life-threatening bleedings were higher in the group receiving aspirin and clopidogrel versus clopidogrel alone (96 [2.6%] vs 49 [1.3%]; absolute risk increase 1.3% [95% CI 0.6 to 1.9]). Major bleedings were also increased in the group receiving aspirin and clopidogrel but no difference was recorded in mortality.Interpretation Adding aspirin to clopidogrel in high-risk patients with recent ischaemic stroke or transient ischaemic attack is associated with a non-significant difference in reducing major vascular events. However, the risk of life-threatening or major bleeding is increased by the addition of aspirin.