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Clinical Trial
. 2022 Dec 12;37(48):e335.
doi: 10.3346/jkms.2022.37.e335.

Outcomes of On-Label Reduced-Dose Edoxaban in Patients With Atrial Fibrillation: The LEDIOS Registry

Ju Youn Kim  1 , Eue Keun Choi  2 , Hong Euy Lim  3 , Yong-Seog Oh  4 , Youngjin Cho  5 , Young Keun On  6
Affiliations
Clinical Trial

Outcomes of On-Label Reduced-Dose Edoxaban in Patients With Atrial Fibrillation: The LEDIOS Registry

Ju Youn Kim et al. J Korean Med Sci. .

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.

Keywords: Atrial Fibrillation; Efficacy; Oral Anticoagulants; Reduced Dose; Safety.

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Conflict of interest statement

The authors have no potential conflicts of interest to disclose. The funding organization made no influence in the present study.

Figures

Fig. 1
Fig. 1. Flow chart of included patients.
AF = atrial fibrillation.
Fig. 2
Fig. 2. Kaplan-Meier curves of the primary outcome. (A) Freedom from major bleeding. (B) Freedom from ischemic strokes or systemic embolisms. (C) Freedom from all cause death. (D) Freedom from composite clinical outcomes.
See this image and copyright information in PMC

References

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