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在非瓣膜病心房颤动患者中利伐沙班与华法林的比较
Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation


Manesh R. Patel ... 心脑血管疾病 • 2011.09.08
相关阅读
• 特定非维生素K拮抗剂口服抗凝药与阿司匹林出血风险比较 • 口服直接抗凝剂与使用华法林治疗静脉血栓栓塞的安全性比较 • 利伐沙班和阿司匹林在预防复发性静脉血栓栓塞方面的比较

摘要


背景

华法林可以降低心房颤动患者缺血性卒中风险,但需要频繁地监测和调整剂量。利伐沙班是一种口服Ⅹa因子抑制剂,与华法林相比,其抗凝效果更加稳定且可预测。

 

方法

本研究为随机双盲临床试验,14,264例较高的卒中风险的非瓣膜病心房颤动患者随机入组,一组口服利伐沙班(20 mg,每天1次),另一组服用校正剂量的华法林。依方案实际治疗的主要分析目的是确定利伐沙班是否在主要终点事件卒中或全身栓塞方面疗效不劣于华法林。

 

结果

在主要分析中,主要终点在利伐沙班组的188例患者中发生(1.7%/年),而华法林组有241例(2.2%/年)(利伐沙班组风险比0.79;95%可信区间[CI],0.66~0.96;非劣效性P<0.001)。在意向治疗分析中,主要终点在利伐沙班组的269例(2.1%/年)患者中发生,华法林组为306例(2.4%/年)(利伐沙班组风险比0.88;95% CI,0.74~1.03;非劣效性P<0.001;优效性P=0.12)。严重和非严重的临床相关出血事件在利伐沙班组为1,475例(14.9%/年),而华法林组为1,449例(14.5%/年)(风险比1.03;95% CI,0.96~1.11;P=0.44);利伐沙班组颅内出血(0.5%对0.7%,P=0.02)和致死性出血(0.2%对0.5%,P=0.003)比例显著低于华法林组。

 

结论

预防心房颤动患者卒中或全身性栓塞,利伐沙班不劣于华法林。尽管利伐沙班组颅内出血和致死性出血发生率更低,但是两组严重出血风险无显著差异(强生和拜耳公司赞助;ROCKET AF ClinicalTrials.gov注册号,NCT00403767)。





作者信息

Manesh R. Patel, M.D., Kenneth W. Mahaffey, M.D., Jyotsna Garg, M.S., Guohua Pan, Ph.D., Daniel E. Singer, M.D., Werner Hacke, M.D., Ph.D., Günter Breithardt, M.D., Jonathan L. Halperin, M.D., Graeme J. Hankey, M.D., Jonathan P. Piccini, M.D., Richard C. Becker, M.D., Christopher C. Nessel, M.D., John F. Paolini, M.D., Ph.D., Scott D. Berkowitz, M.D., Keith A.A. Fox, M.B., Ch.B., Robert M. Califf, M.D., and the ROCKET AF Steering Committee, for the ROCKET AF Investigators*
From the Duke Clinical Research Institute (M.R.P., K.W.M., J.G., J.P.P., R.C.B.) and Duke Translational Medicine Institute (R.M.C.), Duke University Medical Center, Durham, NC; Johnson & Johnson Pharmaceutical Research and Development, Raritan (G.P., C.C.N.), and Bayer HealthCare Pharmaceuticals, Montville (J.F.P., S.D.B.) — both in New Jersey; Massachusetts General Hospital and Harvard Medical School — both in Boston (D.E.S.); Ruprecht-Karls-University, Heidelberg (W.H.), and Hospital of the University of Münster, Münster (G.B.) — both in Germany; the Cardiovascular Institute, Mount Sinai Medical Center, New York (J.L.H.); Royal Perth Hospital, Perth, WA, Australia (G.J.H.); and the University of Edinburgh and Royal Infirmary of Edinburgh — both in Edinburgh (K.A.A.F.). Address reprint requests to Dr. Patel at Duke Clinical Research Institute, Duke University Medical Center, Rm. 0311 Terrace Level, 2400 Pratt St., Durham, NC 27705, or at manesh.patel@duke.edu. * A complete listing of the steering committee members and trial investigators in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) is provided in the Supplementary Appendix, available at NEJM.org.

 

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