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普拉格雷和氯吡格雷治疗未进行血运重建的急性冠脉综合征的疗效对比
Prasugrel versus Clopidogrel for Acute Coronary Syndromes without Revascularization


Matthew T. Roe ... 心脑血管疾病 • 2012.10.04

摘要


背景

目前尚无在未进行血运重建的不稳定型心绞痛或非ST段抬高型心肌梗死患者中应用强化血小板抑制剂治疗效果的报道。

 

方法

在这项随机双盲试验中,主要分析是在7,243例服用阿司匹林的75岁以下患者中进行最长达30个月的普拉格雷(10 mg/d)和氯吡格雷(75 mg/d)的疗效对比研究。次要分析是在2,083例年龄≥75岁患者中,对5 mg/d普拉格雷和75 mg/d氯吡格雷的疗效进行评价。

 

结果

在中位随访时间为17个月的随访期内,主要终点,即心血管原因、心肌梗死或者卒中所致死亡在75岁以下患者普拉格雷组的发生率为13.9%,氯吡格雷组为16.0%(普拉格雷组风险比0.91;95%可信区间[CI],0.79~1.05;P=0.21)。在总人群研究中观察到相似的结果。对多次反复发作的缺血性事件(主要终点的所有组分)的预设分析显示,75岁以下年龄组普拉格雷的风险较低(风险比0.85;95% CI,0.72~1.00;P=0.04)。两个年龄组普拉格雷和氯吡格雷的严重出血和颅内出血发生率相似。除了氯吡格雷组的心力衰竭发生率较高以外,两组间的非出血性严重不良事件的发生率无显著性差异。

 

结论

相对于氯吡格雷,普拉格雷没有显著降低不稳定型心绞痛或非ST段抬高型心肌梗死患者主要终点的发生率;且两者的出血风险相似(由礼来公司[Eli Lilly]和第一三共株式会社[Daiichi Sankyo]资助;TRILOGY ACS ClinicalTrials.gov注册号为NCT00699998)。





作者信息

Matthew T. Roe, M.D., M.H.S., Paul W. Armstrong, M.D., Keith A.A. Fox, M.B., Ch.B., Harvey D. White, M.B., Ch.B., D.Sc., Dorairaj Prabhakaran, M.D., D.M., Shaun G. Goodman, M.D., Jan H. Cornel, M.D., Ph.D., Deepak L. Bhatt, M.D., M.P.H., Peter Clemmensen, M.D., D.M.Sc., Felipe Martinez, M.D., Diego Ardissino, M.D., Jose C. Nicolau, M.D., Ph.D., William E. Boden, M.D., Paul A. Gurbel, M.D., Witold Ruzyllo, M.D., Anthony J. Dalby, M.D., Darren K. McGuire, M.D., M.H.Sc., Jose L. Leiva-Pons, M.D., Alexander Parkhomenko, M.D., Ph.D., Shmuel Gottlieb, M.D., Gracita O. Topacio, M.D., Christian Hamm, M.D., Gregory Pavlides, M.D., Assen R. Goudev, M.D., Ali Oto, M.D., Chuen-Den Tseng, M.D., Ph.D., Bela Merkely, M.D., Ph.D., D.Sc., Vladimir Gasparovic, M.D., Ph.D., Ramon Corbalan, M.D., Mircea Cinteză, M.D., Ph.D., R. Craig McLendon, R.N., Kenneth J. Winters, M.D., Eileen B. Brown, Ph.D., Yuliya Lokhnygina, Ph.D., Philip E. Aylward, B.M., B.Ch., Ph.D., Kurt Huber, M.D., Judith S. Hochman, M.D., and E. Magnus Ohman, M.B., Ch.B., for the TRILOGY ACS Investigators*
The authors' affiliations are listed in the Appendix. Address reprint requests to Dr. Roe at Duke Clinical Research Institute, 2400 Pratt St., Rm. 7035, Durham, NC 27705, or at matthew.roe@duke.edu. *The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) investigators are listed in the Supplementary Appendix, available at NEJM.org.

 

参考文献

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