Key result
In 944,776 Japanese patients with NVAF, reduced or standard doses of DOACs had equal or lower risks of stroke/systemic embolism and major bleeding compared to warfarin.
Why the study?
To compare the effectiveness and safety of reduced or standard daily doses of DOACs with warfarin in Japanese patients with nonvalvular atrial fibrillation, and identify patient groups benefiting from reduced doses.
Do reduced or standard daily doses of DOACs reduce stroke, systemic embolism, and major bleeding compared to warfarin in Japanese patients with nonvalvular atrial fibrillation?
Cohort (n=944,776)
Yes
Do reduced or standard daily doses of DOACs reduce stroke, systemic embolism, and major bleeding compared to warfarin in Japanese patients with nonvalvular atrial fibrillation?
In a large Japanese cohort, both reduced and standard doses of DOACs demonstrated equal or superior effectiveness and safety compared to warfarin for patients with nonvalvular atrial fibrillation.
May support DOACs over warfarin in Japanese NVAF; extends observational data but leaves RCTs needed.
Purpose: To compare the effectiveness and safety of reduced or standard daily doses of direct oral anticoagulants (DOACs) with warfarin in Japanese patients with nonvalvular atrial fibrillation (NVAF). We used post-hoc analyses to identify patient groups that could benefit from reduced-dose DOACs. Patients and Methods: Using the National Database of Health Insurance Claims and Specific Health Checkups of Japan, we identified 944,776 patients with NVAF who had started an oral anticoagulant after at least one year of non-use between April 2011 and March 2016. We matched patients taking any, reduced, or standard doses of DOACs 1:1 with those taking warfarin. We measured treatment effectiveness based on admission due to stroke or systemic embolism (S/SE) and safety based on admission due to any bleeding (defined as major bleeding, MB). We compared both outcomes between DOACs and warfarin using the Cox proportional hazards model. We used post-hoc analysis to match patients receiving reduced-dose DOACs to those receiving standard-dose DOACs and compared treatment effectiveness and safety. Results: More than half of patients receiving DOACs used a reduced dose. The occurrences of S/SE and MB in patients receiving any, reduced, or standard doses of DOACs were equal to or lower than those receiving warfarin. In the post-hoc analysis, the risk of S/SE and MB was similar between reduced and standard doses of DOACs except for those with a history of cerebral infarction and CHA 2 DS 2 -VASc score ≥ 3, where the risk of S/SE was lower for reduced doses of any and individual DOACs. Conclusion: Findings from the current study are consistent with recent Asian and global studies but different from most studies conducted in North America and Europe, where patients receiving a reduced dose of DOACs had an increased risk of S/SE. Future studies should test the reproducibility of results from the current study.
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Kubota et al. (2022) conducted a cohort in nonvalvular atrial fibrillation (NVAF) (n=944,776). Direct oral anticoagulants (DOACs) vs. Warfarin was evaluated on Admission due to stroke or systemic embolism (S/SE) and admission due to any bleeding (major bleeding). In 944,776 Japanese patients with NVAF, reduced or standard doses of DOACs had equal or lower risks of stroke/systemic embolism and major bleeding compared to warfarin.
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