Ticagrelor with or without Aspirin in High-Risk Patients after PCI
Ticagrelor with or without Aspirin in High-Risk Patients after PCI
复制标题
DOI：
10.1056/nejmoa1908419
复制
发表时间：
2019-11-21
影响因子：
158.5
通讯作者：
Gibson, C. M.
中科院分区：
文献类型：
--
作者：
Mehran, R.;Baber, U.;Gibson, C. M.
背景：经皮冠状动脉介入治疗（PCI）后，在至少一段时间的双重抗血小板治疗后使用P2Y（12）抑制剂进行单药治疗是降低PCI术后出血风险的一种新兴方法。方法：在一项双盲试验中，我们比较了替格瑞洛单独使用与替格瑞洛加阿司匹林在接受PCI治疗的高危出血或缺血性事件患者中临床相关出血的影响。替格瑞洛加阿司匹林治疗3个月后，未发生大出血事件或缺血性事件的患者继续服用替格瑞洛，并随机分配接受阿司匹林或安慰剂治疗1年。主要终点为出血学术研究联盟（BARC） 2、3或5型出血。我们还使用绝对误差为1.6个百分点的非劣效性假设，评估了任何原因、非致死性心肌梗死或非致死性卒中的复合终点死亡。结果我们入组了9006例患者，其中7119例在3个月后进行了随机分组。在随机化和1年间，随机分配到替格瑞洛加安慰剂组的患者的主要终点发生率为4.0%，分配到替格瑞洛加阿司匹林组的患者的主要终点发生率为7.1%(风险比为0.56；95%可信区间[CI]， 0.45 ~ 0.68
BACKGROUNDMonotherapy with a P2Y(12) inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI).METHODSIn a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points.RESULTSWe enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [CI], 0.45 to 0.68; P