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药物洗脱支架置入后双重抗血小板治疗12或30个月的比较
Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents


Laura Mauri ... 心脑血管疾病 • 2014.12.04
相关阅读
• 将双联抗血小板治疗限制在3个月可否减少出血 • 支架置入术后的1年双联抗血小板治疗是否真有必要

摘要


背景

双重抗血小板治疗被推荐用于冠脉支架置入后,以预防血栓并发症,但这种治疗1年以上的获益和危险尚未确定。

 

方法

接受了冠脉支架术置入药物洗脱支架的患者被纳入本研究。采用噻吩吡啶类药物(氯吡格雷或普拉格雷)联合阿司匹林治疗12个月后,患者被随机分配继续接受另外18个月的噻吩吡啶治疗或安慰剂,所有患者均继续接受阿司匹林治疗。共同主要疗效终点为12~30个月期间的支架内血栓形成和主要不良心血管和脑血管事件(为死亡、心肌梗死或卒中的复合事件),主要安全性终点为中度或严重的出血事件。

 

结果

共9,961名患者被随机分配继续接受噻吩吡啶治疗或安慰剂。与安慰剂相比,噻吩吡啶持续治疗降低了支架内血栓形成(0.4%对1.4%;风险比,0.29[95%可信区间{CI},0.17~0.48],P<0.001)和主要不良心血管和脑血管事件(4.3%对5.9%;风险比,0.71[95% CI,0.59~0.85];P<0.001)的发生率。噻吩吡啶治疗组心肌梗死发生率低于安慰剂组(2.1%对4.1%;风险比,0.47;P<0.001)。持续噻吩吡啶治疗组任何原因死亡的发生率为2.0%,安慰剂组为1.5%(风险比,1.36[95% CI,1.00~1.85];P=0.05)。中度或重度出血事件发生率随着噻吩吡啶的持续治疗而增高(2.5%对1.6%;P=0.001)。两组患者停用噻吩吡啶治疗后3个月内,支架内血栓形成和心肌梗死发生率均升高。

 

结论

置入药物洗脱支架后采用双重抗血小板治疗1年以上,与阿司匹林单药治疗相比,可以显著降低支架内血栓形成和主要不良心血管和脑血管事件危险,但与出血风险升高相关(由8家器械及药物制造厂商等联合资助,DAPT在ClinicalTrials.gov注册号为NCT00977938)。





作者信息

Laura Mauri, M.D., Dean J. Kereiakes, M.D., Robert W. Yeh, M.D., Priscilla Driscoll-Shempp, M.B.A., Donald E. Cutlip, M.D., P. Gabriel Steg, M.D., Sharon-Lise T. Normand, Ph.D., Eugene Braunwald, M.D., Stephen D. Wiviott, M.D., David J. Cohen, M.D., David R. Holmes, Jr., M.D., Mitchell W. Krucoff, M.D., James Hermiller, M.D., Harold L. Dauerman, M.D., Daniel I. Simon, M.D., David E. Kandzari, M.D., Kirk N. Garratt, M.D., David P. Lee, M.D., Thomas K. Pow, M.D., Peter Ver Lee, M.D., Michael J. Rinaldi, M.D., and Joseph M. Massaro, Ph.D., for the DAPT Study Investigators*
The authors' affiliations are listed in the Appendix. Address reprint requests to Dr. Mauri at the Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, or at lmauri1@partners.org. *A complete list of investigators and committee members in the Dual Antiplatelet Therapy (DAPT) study is provided in the Supplementary Appendix, available at NEJM.org.

 

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