Objective: To investigate the efficacy and safety of dabigatran and warfarin in patients with atrial fibrillation in patients with nonvalvular disease in RE-LY and its effect on stroke prevention. Methods: The RE-LY test was a prospective, multi-center, randomized, parallel group design of the clinical trial. 13 medical centers from March 2006 to March 2009 were selected 541 cases of stroke risk of patients with nonvalvular atrial fibrillation, taking 110 mg, 2 times (180 cases) and 150 mg, 2 times / d (181 cases) of two fixed doses of dabigatran (each of which were administered blindly) with open-label warfarin patients (180 patients, target International standardized ratio of 2.0 to 3.0). The primary outcome endpoint was the annual incidence of stroke and / or systemic circulation embolization, and the primary safety endpoint was the annual incidence of major bleeding. Results: Daibigu group 110 mg group, The incidence of stroke or systemic embolism in the group of 150 mg and warfarin groups was 7 (1.94% / year), 4 (1.10% / year) and 10 (2.87% / year), respectively Ischemic stroke was 4 cases (1.11% / year), 3 cases (0.82% / year) and 7 cases (2.01% / year), hemorrhagic stroke were 1 case (0.28% / year), 1 (0.27% / year) and 8 cases (2.57% / year); all-cause mortality was 12 cases (3.33% / year), 8 cases (2.19% / year) and 9 cases (2.58% / year). There were 2 cases (0.56% / year) of hemorrhagic in the two dose groups of Dabiga group and 5 cases (1.43% / year) in the warfarin group. Digestion of two groups of dabigatran group and warfarin group The incidence of adverse events (especially abdominal discomfort and upper abdominal pain) was 12.8% (23/179), 12.8% (23/180) and 5.6% (10/180) respectively. Conclusion: As with warfarin, dabigatran can be safe and effective for non-valvular heart disease in patients with atrial fibrillation in the prevention of thromboembolism in Chinese patients with atrial fibrillation at risk of stroke.
Zhonghua Xin Xue Guan Bing Za Zhi 2016;44:929-34