Key result
Dabigatran was associated with a reduced risk of stroke or systemic embolism compared with warfarin (HR 0.48; 95% CI 0.25-0.91) in younger Japanese patients with non-valvular atrial fibrillation.
Why the study?
Oral anticoagulant use has increased rapidly internationally, prompting an evaluation of the risks and benefits of therapy in Japanese patients with non-valvular atrial fibrillation.
Does dabigatran reduce stroke or systemic embolism compared to warfarin in Japanese patients aged 18-74 years with non-valvular atrial fibrillation?
Cohort (n=1,536)
Does dabigatran reduce stroke or systemic embolism compared to warfarin in Japanese patients aged 18-74 years with non-valvular atrial fibrillation?
Hazard Ratio: 0.48 (95% CI 0.25–0.91)
In younger Japanese patients with non-valvular atrial fibrillation, dabigatran was associated with a significantly lower risk of stroke or systemic embolism and a similar risk of bleeding compared to warfarin.
Dabigatran was associated with lower stroke risk and similar bleeding versus warfarin in young Japanese NVAF patients; leaves open generalizability beyond this low-risk cohort.
BACKGROUND: Oral anticoagulants use has increased rapidly, internationally. Here we look at risks and benefits, based on Japanese data, of therapy with low risk non-valvular atrial fibrillation patients. OBJECTIVES: Using a health insurance claims data set we assessed: (i) oral anticoagulants usage in Japan, and (ii) efficacy and safety of dabigatran compared with warfarin, in Japanese patients with non-valvular atrial fibrillation, aged 18-74 years. METHODS: We identified 4380 non-valvular atrial fibrillation patients treated with anticoagulants between 1 January 2005, and 28 February 2014, and estimated the adjusted hazard ratio for stroke or systemic embolism, and any hemorrhagic event (Cox proportional hazards regression model with stabilized inverse probability treatment weighting). RESULTS: The data included 101 989 anticoagulant prescriptions for 4380 patients, of which direct oral anticoagulants increased to 40.0% of the total by the end of the study. After applying exclusion criteria, 1536 new non-valvular atrial fibrillation patients were identified, including 1071 treated with warfarin and 465 with dabigatran. Mean ages were 56.11 ± 9.70 years for warfarin, and 55.80 ± 9.65 years for dabigatran. The adjusted hazard ratio (95% confidence interval), comparing dabigatran with warfarin, was 0.48 (0.25-0.91) for stroke or systemic embolism, and 0.91 (0.60-1.39) for any hemorrhage including intracranial and gastrointestinal. CONCLUSIONS: Number of patients prescribed direct oral anticoagulants steadily increased, and incidence of all-cause bleeding related to dabigatran was similar to warfarin, in our study population of younger non-valvular atrial fibrillation patients. Dabigatran, compared with warfarin, generally reduced risk of all-cause stroke and systemic embolism.
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Ohshima et al. (2019) conducted a cohort in non-valvular atrial fibrillation (n=1,536). Dabigatran vs. Warfarin was evaluated on stroke or systemic embolism (HR 0.48, 95% CI 0.25-0.91). Dabigatran was associated with a reduced risk of stroke or systemic embolism compared with warfarin (HR 0.48; 95% CI 0.25-0.91) in younger Japanese patients with non-valvular atrial fibrillation.
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