Key result
Dabigatran was associated with a significantly lower risk of all major bleeding (HR 0.41) compared to antiplatelet agents in Asian patients with non-valvular atrial fibrillation.
Why the study?
Does dabigatran, rivaroxaban, or warfarin reduce bleeding risk compared to antiplatelet agents in Asian patients with non-valvular atrial fibrillation?
Cohort (n=23,343)
Does dabigatran, rivaroxaban, or warfarin reduce bleeding risk compared to antiplatelet agents in Asian patients with non-valvular atrial fibrillation?
Hazard Ratio: 0.41 (95% CI 0.32–0.53)
Absolute Event Rate: 1.8% vs 4.34%
p-value: p=<0.0001
In Asian patients with non-valvular atrial fibrillation, dabigatran was associated with a significantly lower risk of major bleeding compared to antiplatelet agents, whereas rivaroxaban and warfarin had similar major bleeding risks as antiplatelet agents.
May warrant caution against antiplatelet preference in Asian nonvalvular AF; hypothesis-generating and requires randomized confirmation.
// Yi-Hsin Chan 1, 2, 3, * , Yung-Hsin Yeh 1, 2, * , Hui-Tzu Tu 4 , Chi-Tai Kuo 1, 2 , Shang-Hung Chang 1, 2, 5 , Lung-Sheng Wu 1, 2 , Hsin-Fu Lee 1, 2 and Lai-Chu See 4, 6, 7 1 The Cardiovascular Department, Chang-Gung Memorial Hospital, Taoyuan, Taiwan 2 College of Medicine, Chang-Gung University, Taoyuan, Taiwan 3 Microscopy Core Laboratory, Chang-Gung Memorial Hospital, Taoyuan, Taiwan 4 Department of Public Health, College of Medicine, Chang-Gung University, Taoyuan, Taiwan 5 Center for Big Data Analytics and Statistics, Chang-Gung Memorial Hospital, Taoyuan, Taiwan 6 Biostatistics Core Laboratory, Molecular Medicine Research Center, Chang-Gung University, Taoyuan, Taiwan 7 Division of Rheumatology, Allergy and Immunology, Department of Internal Medicine, Chang-Gung Memorial Hospital, Taoyuan, Taiwan * These authors have contributed equally to this work Correspondence to: Lai-Chu See, email: lichu@mail.cgu.edu.tw Keywords: atrial fibrillation; direct thrombin inhibitor; factor xa inhibitor; hemorrhage; warfarin Received: August 08, 2017 Accepted: September 22, 2017 Published: October 24, 2017 ABSTRACT It is not understood if dabigatran or rivaroxaban are superior to antiplatelet agents (AA) for safety outcomes in Asians with non-valvular atrial fibrillation (NVAF). In this study we evaluated the bleeding risk of dabigatran, rivaroxaban, warfarin and AA in Asians with NVAF. This national retrospective cohort study analyzed 6,600, 3,167, 5,338 and 8,238 consecutive NVAF patients taking dabigatran, rivaroxaban, warfarin or AAs (including aspirin, clopidogrel or ticlopidine), respectively, from June 1, 2012 to December 31, 2013. Propensity-score weighting was used to balance covariates across study groups. Patients were followed until the first occurrence of any bleeding outcome or the end of the study. The CHA 2 DS 2 -VASc scores were 4.1±1.6, 4.1±1.6, 3.3±1.8 and 2.4±1.6 for the dabigatran, rivaroxaban, warfarin, and AA groups, respectively. There were 5,822 (88.2%) and 164 (5.2%) patients taking low dose dabigatran and rivaroxaban, respectively. Hazard ratios (95% confidence intervals) for dabigatran, rivaroxaban, or warfarin versus AA were: intracranial hemorrhage, 0.36 (0.23-0.57; P <0.0001), 0.25 (0.10-0.64; P =0.0037) and 1.34 (0.89-2.02; P =0.1664); gastrointestinal bleeding, 0.44 (0.32-0.59; P <0.0001), 1.09 (0.61-1.93;P=0.7694), and 0.68 (0.49-0.94; P =0.0189); and all hospitalized major bleeding, 0.41 (0.32-0.53; P <0.0001), 0.65 (0.41-1.03; P =0.0644) and 0.90 (0.70-1.16; P =0.4130) after adjustment. The risk reduction of all major bleeding for dabigatran versus AA persisted on subgroup analysis. In conclusion, we observed that dabiagtran was associated with a lower risk of all major bleeding in Asians with NVAF, whereas rivaroxaban had a similar risk of all major bleeding compared with antiplatelet agents after adjustment of comorbidities.
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Chan et al. (2017) conducted a cohort in Non-valvular atrial fibrillation (n=23,343). Dabigatran vs. Antiplatelet agents was evaluated on All hospitalized major bleeding (HR 0.41, 95% CI 0.32-0.53, p=<0.0001). Dabigatran was associated with a significantly lower risk of all major bleeding (HR 0.41) compared to antiplatelet agents in Asian patients with non-valvular atrial fibrillation.
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