Outcomes of On-Label Reduced-Dose Edoxaban in Patients With Atrial Fibrillation: The LEDIOS Registryopen access
- Authors
- Kim, J.Y.[Kim, J.Y.]; Choi, E.K.[Choi, E.K.]; Lim, H.E.[Lim, H.E.]; Oh, Y.-S.[Oh, Y.-S.]; Cho, Y.[Cho, Y.]; On, Y.K.[On, Y.K.]
- Issue Date
- 12-Dec-2022
- Publisher
- Korean Academy of Medical Science
- Keywords
- Atrial fibrillation; Efficacy; Oral anticoagulants; Reduced dose; Safety
- Citation
- Journal of Korean Medical Science, v.37, no.48
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- Journal of Korean Medical Science
- Volume
- 37
- Number
- 48
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/105628
- DOI
- 10.3346/jkms.2022.37.e335
- ISSN
- 1011-8934
- Abstract
- 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: A total of 2,448 patients (mean age 75.0 ± 8.3 years, 801 [32.7%] males) was included in the present study. The mean CHA2DS2-VASc score was 3.7 ± 1.5. Major bleeding events occurred at a rate of 1.34%/yr. The event rate of strokes and systemic embolisms was 1.13%/ yr. The overall net clinical outcomes occurred at a rate of 3.19%/yr. There were no significant differences according to the number of dose reduction criteria, renal dysfunction, or body weight. Higher HAS-BLED score and higher combination of CHA2DS2-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 © 2022 The Korean Academy of Medical Sciences.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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