Clopidogrel with or without Omeprazole in Coronary Artery Disease.
Clopidogrel with or without Omeprazole in Coronary Artery Disease.
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DOI：
10.1056/nejmoa1007964
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发表时间：
2010-11-11
影响因子：
158.5
通讯作者：
Cannon, Christopher P.
中科院分区：
文献类型：
--
作者：
Bhatt, Deepak L.;Cryer, Byron L.;Cannon, Christopher P.
背景：胃肠道并发症是抗血栓治疗的一个重要问题。质子泵抑制剂（PPI）被认为可以降低此类并发症的风险，尽管没有随机试验在接受双重抗血小板治疗的患者中证明这一点。最近，人们担心PPI可能会削弱氯吡格雷的疗效。方法：我们随机分配有双重抗血小板治疗适应症的患者，除阿司匹林外，还接受氯吡格雷联合奥美拉唑或安慰剂。主要胃肠道终点是显性或隐性出血、症状性胃十二指肠溃疡或糜烂、梗阻或穿孔的复合终点。主要心血管终点是心血管原因死亡、非致死性心肌梗死、血运重建或卒中的复合终点。试验提前终止时，主办方失去financing.Results：我们计划招募约5000例患者，共3873随机分配和3761被纳入分析。总共有51名患者发生胃肠道事件; 180天时，奥美拉唑组的事件发生率为1.1%，安慰剂组为2.9%（奥美拉唑组的风险比为0.34，95%置信区间[CI]为0.18 - 0.63; P
Background: Gastrointestinal complications are an important problem of antithrombotic therapy. Proton-pump inhibitors (PPIs) are believed to decrease the risk of such complications, though no randomized trial has proved this in patients receiving dual antiplatelet therapy. Recently, concerns have been raised about the potential for PPIs to blunt the efficacy of clopidogrel.Methods: We randomly assigned patients with an indication for dual antiplatelet therapy to receive clopidogrel in combination with either omeprazole or placebo, in addition to aspirin. The primary gastrointestinal end point was a composite of overt or occult bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation. The primary cardiovascular end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction, revascularization, or stroke. The trial was terminated prematurely when the sponsor lost financing.Results: We planned to enroll about 5000 patients; a total of 3873 were randomly assigned and 3761 were included in analyses. In all, 51 patients had a gastrointestinal event; the event rate was 1.1% with omeprazole and 2.9% with placebo at 180 days (hazard ratio with omeprazole, 0.34, 95% confidence interval [CI], 0.18 to 0.63; P