Key result
Dabigatran was comparable to warfarin for preventing thromboembolism (HR 1.03; 95% CI 0.12-8.04) but was associated with a lower risk of major bleeding (HR 0.15; 95% CI 0.01-0.90).
Why the study?
Does dabigatran reduce thromboembolism and major bleeding compared to warfarin in real-world Japanese patients with non-valvular atrial fibrillation?
Observational (n=362)
No
Does dabigatran reduce thromboembolism and major bleeding compared to warfarin in real-world Japanese patients with non-valvular atrial fibrillation?
Hazard Ratio: 1.03 (95% CI 0.12–8.04)
p-value: p=0.971
In a real-world cohort of Japanese patients with non-valvular atrial fibrillation, dabigatran provided comparable thromboembolism prevention to warfarin but with a significantly lower risk of major bleeding.
Supports dabigatran for lower bleeding in Japanese NVAF; hypothesis-generating and should not yet change practice.
Background In “real‐world” practice, anticoagulant therapy is indicated for patients whose clinical profiles are not addressed in randomized clinical trials. We assessed the effectiveness and safety of dabigatran versus warfarin in “real‐world” Japanese patients with non‐valvular atrial fibrillation (NVAF). Methods Among 613 NVAF patients who initiated dabigatran or warfarin therapy during the period between 2011 and 2013, 362 patients were included in the study after propensity score adjustment. The median follow‐up period was 1.3 years. The effectiveness and safety outcomes were thromboembolism and major bleeding, respectively. Results The propensity‐matched hazard ratios of thromboembolism and major bleeding with dabigatran were 1.03 (95% CI: 0.12–8.04, p =0.971) and 0.15 (95% CI: 0.01–0.90, p =0.037), respectively. Conclusions The ability of dabigatran to prevent thromboembolism is comparable to that of warfarin; however, the major bleeding rate is lower with dabigatran in “real‐world” NVAF patients.
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Naganuma et al. (2016) conducted an observational in non-valvular atrial fibrillation (NVAF) (n=362). Dabigatran vs. Warfarin was evaluated on thromboembolism (HR 1.03, 95% CI 0.12-8.04, p=0.971). Dabigatran was comparable to warfarin for preventing thromboembolism (HR 1.03; 95% CI 0.12-8.04) but was associated with a lower risk of major bleeding (HR 0.15; 95% CI 0.01-0.90).
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