Dabigatran versus warfarin for the prevention of stroke in Chinese patients with nonvalvular atrial fibrillation:Chinese subpopulation analysis of RE-LY
10.3760/cma.j.issn.0253-3758.2016.11.006
- VernacularTitle:达比加群与华法林在中国非瓣膜病心房颤动患者卒中预防中的对照研究:RE-LY研究中国亚组分析
- Author:
Xin GAO
1
;
Yanmin YANG
;
Jun ZHU
;
Yan DAI
;
Huiqiong TAN
Author Information
1. 100037,中国医学科学院北京协和医学院阜外医院心内科急重症中心
- Keywords:
Atrial fibrillation;
Anticoagulants;
Cerebrovascular accident
- From:
Chinese Journal of Cardiology
2016;44(11):929-934
- CountryChina
- Language:Chinese
-
Abstract:
Objective This analysis was performed to evaluate the efficacy in stroke prevention and safety of dabigatran in Chinese nonvalvular atrial fibrillation (NVAF) patients enrolled in RE-LY trial.Methods RE-LY was an prospective,open-label,randomized,multicenter study.From March 2006 to March 2009,541 atrial fibrillation patients at risk of stroke were recruited from 13 medical centers in China.Patients randomly received,in a blinded fashion,fixed doses of dabigatran-110 mg or 150 mg twice daily or,in an unblinded fashion,adjusted-dose warfarin.The primary efficacy endpoint was stroke or systemic embolism.The primary safety endpoint was major bleeding.Results The incidence of stroke in the Chinese subpopulation was 1.94％ per year(7 cases) in the group that received 110 mg of dabigatran (dabigatran 110) and 1.10％ per year (4 cases) in the group that received 150 mg of dabigatran (dabigatran 150),as compared with 2.87％ per year (10 cases) in warfarin group.Incidence of ischemic stroke was 1.11％ per year(4 patients) in dabigatran 110 group,0.82％ per year(3 cases) in dabigatran 150 group and 2.01％ per year(7 patients) in warfarin group.Incidence of hemorrhagic stroke was 0.28％per year(1 case) in dabigatran 110 group,0.27％ per year(1 case) in dabigatran 150 group and 0.57％per year(2 cases) in warfarin group.All-cause mortality was similar among the three treatment groups:3.33％ per year (12 cases) in dabigatran 110,2.19％ per year(8 cases) in dabigatran 150 and 2.58％per year(9 cases) in warfarin group.Incidence of major bleeding event was 0.56％ per year(2 cases) in both dabigatran groups,as compared with 1.43％ per year(5 cases) in warfarin group.Gastrointestinal disorders such as dyspepsia occurred in 12.8％ patients of both dabigatran groups,and in 5.6％ patients of warfarin group.Conclusions Despite the descriptive statistical analysis in nature of present study due to the limited number of subjects,our subgroup analysis implies that like warfarin,dabigatran is efficacious and safe for thromboembolism prevention in Chinese patients with atrial fibrillation at risk of stroke.Clinical Trail Registry National Institutes of Health (http://www.clinicaltrials.gov),CT00262600.
