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利伐沙班在近期发生急性冠脉综合征患者中的应用
Rivaroxaban in Patients with a Recent Acute Coronary Syndrome


Jessica L. Mega ... 心脑血管疾病 • 2012.01.05
相关阅读
• 冠心病的新辅助疗法? • 利伐沙班联用或不联用阿司匹林治疗稳定性心血管疾病

摘要


背景

急性冠脉综合征(ACS)是由冠状动脉粥样硬化叠加血栓形成而引起的。由于Xa因子在血栓形成中发挥着核心作用,而利伐沙班是Xa因子抑制剂,因此给近期发生过急性冠脉综合征的患者应用小剂量利伐沙班或许可以改善此类患者的心血管结局。

 

方法

本项双盲、安慰剂对照试验共纳入15,526名近期发生过急性冠脉综合征的患者,并随机分为三组:两个治疗组应用利伐沙班(每次2.5 mg或每次5 mg,每天2次),对照组应用安慰剂;随访时间最长为31个月,平均13个月。主要有效性终点是由心血管原因、心肌梗死或卒中所导致的死亡。

 

结果

与安慰剂组相比,利伐沙班组显著减少了主要疗效终点事件的发生,两者的发生率分别为8.9%和10.7%(利伐沙班组对安慰剂组的风险比,0.84;95%可信区间,0.74~0.96;P=0.008)。与安慰剂组相比,2.5 mg剂量组和5 mg剂量组均显著改善了主要终点事件的发生率(分别为9.1%对10.7%,P=0.02;8.8%对10.7%,P=0.03)。2.5 mg利伐沙班组明显降低了心血管死亡(2.7%对4.1%,P=0.002)和全因死亡(2.9%对4.5%,P=0.002)的发生率,但是在5 mg剂量组并没有观察到此类生存获益。与安慰剂相比,利伐沙班明显增加了非冠状动脉旁路移植术相关的严重出血(2.1%对0.6%,P<0.001)和颅内出血(0.6%对0.2%,P=0.009)的发生率,但并未明显增加致死性出血(0.3%对0.2%,P=0.66)或其他不良事件的发生率。与5 mg剂量组相比,2.5 mg利伐沙班组发生致死性出血事件的风险更低(0.1%对0.4%,P=0.04)。

 

结论

在近期发生过急性冠脉综合征的患者中,应用利伐沙班可降低由心血管原因、心肌梗死或卒中导致的死亡复合终点事件的发生风险。利伐沙班增加了严重出血和颅内出血发生的风险,但并未增加致死性出血发生的风险。(由强生[Johnson & Johnson]和拜耳[Bayer Healthcare]公司资助;ATLAS ACS 2–TIMI 51在ClinicalTrials.gov注册号为NCT00809965)





作者信息

Jessica L. Mega, M.D., M.P.H., Eugene Braunwald, M.D., Stephen D. Wiviott, M.D., Jean-Pierre Bassand, M.D., Deepak L. Bhatt, M.D., M.P.H., Christoph Bode, M.D., Paul Burton, M.D., Ph.D., Marc Cohen, M.D., Nancy Cook-Bruns, M.D., Keith A.A. Fox, M.B., Ch.B., Shinya Goto, M.D., Sabina A. Murphy, M.P.H., Alexei N. Plotnikov, M.D., David Schneider, M.D., Xiang Sun, Ph.D., Freek W.A. Verheugt, M.D., and C. Michael Gibson, M.D., for the ATLAS ACS 2–TIMI 51 Investigators*
The authors' affiliations are listed in the Appendix. Address reprint requests to Dr. Mega at the Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, or at jmega@partners.org. *Investigators in the Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome–Thrombolysis in Myocardial Infarction 51 (ATLAS ACS 2–TIMI 51) are listed in the Supplementary Appendix, available at NEJM.org.

 

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