Why the study?
Few reports exist on the outcomes of on-label reduced-dose NOACs, prompting an evaluation of the safety and efficacy of on-label reduced-dose edoxaban in AF patients.
On-label reduced-dose edoxaban (30 mg) demonstrated low rates of major bleeding and stroke in a real-world East Asian cohort with atrial fibrillation meeting dose reduction criteria.
Reduced-dose edoxaban showed acceptable event rates in this Asian AF cohort; leaves open need for randomized trials in high-bleeding-risk subgroups.
BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are effective in preventing thromboembolisms and reduce the risk of bleeding compared with warfarin. There are few reports on the outcomes of on-label reduced-dose NOACs. The aim of this study was to assess the safety and efficacy of on-label reduced-dose edoxaban in patients with atrial fibrillation (AF). METHODS: This study is a multi-center, prospective, non-interventional study to evaluate the safety and efficacy of on-label reduced-dose edoxaban in patients with AF. We evaluated outcomes of major bleeding, stroke or systemic embolism, all-cause death, and composite clinical outcomes. RESULTS: -VASc and HAS-BLED score was associated with an increased risk of composite clinical outcomes compared to the lower score groups. CONCLUSIONS: This study was the largest prospective real-world study to investigate the safety and efficacy of on-label low-dose edoxaban in an Asian population. Reduced-dose edoxaban can be used safely in patients with severe renal dysfunction or extremely low body weight. Our observation suggests that physicians should consider bleeding risk even in a low-dose regimen. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03554837.
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Kim et al. (2022) studied this question.
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