ROCKET AF 试验中的利伐沙班用于东亚患者的卒中预防。
Rivaroxaban for stroke prevention in East Asian patients from the ROCKET AF trial.
机构信息
From the Department of Medicine and Therapeutics, Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, China (K.S.L.W.); Heart Center, Peking University People's Hospital, Beijing, China (D.Y.H.); Department of Cardiology, Apollo Hospital, Chennai, India (A.O.); National Heart Centre, Singapore, Singapore (R.-S.T.); Department of Medicine, Division of Cardiology, Duke Clinical Research Institute (M.R.P., K.W.M., R.C.B.) and Department of Medicine, Division of Cardiology, Duke Translational Medicine Institute (R.C.), Duke University Medical Center, Durham, NC; Department of Epidemiology, Massachusetts General Hospital and Harvard Medical School, Boston (D.E.S.); Department of Cardiovascular Medicine, University Hospital Münster, Münster, Germany (G.B.); Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, Scotland (K.A.A.F.); Bayer HealthCare Pharmaceuticals, Montville, NJ (S.D.B.); Department of Neurology, Ruprecht-Karls-University, Heidelberg, Germany (W.H.); and Stroke Unit, Department of Neurology, Royal Perth Hospital, University of Western Australia, Perth, Australia (G.J.H.).
出版信息
Stroke. 2014 Jun;45(6):1739-47. doi: 10.1161/STROKEAHA.113.002968. Epub 2014 Apr 24.
BACKGROUND AND PURPOSE
In Rivaroxaban Once Daily Oral Direct Factor Xa Inhibitor Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial, rivaroxaban was noninferior to dose-adjusted warfarin in preventing stroke or systemic embolism among patients with nonvalvular atrial fibrillation at moderate to high stroke risk. Because of differences in patient demographics, epidemiology, and stroke risk management in East Asia, outcomes and relative effects of rivaroxaban versus warfarin were assessed to determine consistency among East Asians versus other ROCKET AF participants.
METHODS
Baseline demographics and interaction of treatment effects of rivaroxaban and warfarin among patients within East Asia and outside were assessed.
RESULTS
A total of 932 (6.5%) ROCKET AF participants resided in East Asia. At baseline, East Asians had lower weight, creatinine clearance, and prior vitamin K antagonist use; higher prevalence of prior stroke; and less congestive heart failure and prior myocardial infarction than other participants. Despite higher absolute event rates for efficacy and safety outcomes in East Asians, the relative efficacy of rivaroxaban (20 mg once daily; 15 mg once daily for creatinine clearance of 30-49 mL/min) versus warfarin with respect to the primary efficacy end point (stroke/systemic embolism) was consistent among East Asians and non-East Asians (interaction P=0.666). Relative event rates for the major or nonmajor clinically relevant bleeding in patients treated with rivaroxaban and warfarin were consistent among East Asians and non-East Asians (interaction P=0.867).
CONCLUSIONS
Observed relative efficacy and safety of rivaroxaban versus warfarin were similar among patients within and outside East Asia. Rivaroxaban, 20 mg once daily, is an alternative to warfarin for stroke prevention in East Asians with nonvalvular atrial fibrillation.
背景与目的
在 Rivaroxaban Once Daily Oral Direct Factor Xa Inhibitor Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation（ROCKET AF）试验中，利伐沙班在预防非瓣膜性心房颤动中具有中至高度卒中风险的患者的卒中或全身性栓塞方面不劣于调整剂量的华法林。由于东亚地区患者人口统计学、流行病学和卒中风险管理方面的差异，评估了利伐沙班与华法林的结果和相对疗效，以确定东亚地区与其他 ROCKET AF 参与者之间的一致性。
方法
评估了东亚地区和非东亚地区患者的基线人口统计学特征和利伐沙班与华法林治疗效果的相互作用。
结果
共有 932 名（6.5%）ROCKET AF 参与者居住在东亚地区。基线时，东亚地区患者体重、肌酐清除率和之前使用维生素 K 拮抗剂较低；既往卒中发生率较高；充血性心力衰竭和既往心肌梗死发生率较低。尽管东亚地区患者的有效性和安全性结局的绝对事件发生率较高，但利伐沙班（每日 20 毫克；肌酐清除率为 30-49 毫升/分钟时每日 15 毫克）与华法林治疗相比，主要疗效终点（卒中/全身性栓塞）的相对疗效在东亚地区和非东亚地区患者中是一致的（相互作用 P=0.666）。利伐沙班和华法林治疗患者的主要或非主要临床相关出血的相对事件发生率在东亚地区和非东亚地区患者中是一致的（相互作用 P=0.867）。
结论
在东亚地区和非东亚地区患者中，观察到的利伐沙班相对于华法林的疗效和安全性相似。对于非瓣膜性心房颤动的东亚患者，利伐沙班 20 毫克每日一次是华法林预防卒中的替代选择。
Zotero 插件