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

J Korean Med Sci. 2022 Dec 12;37(48):e335. doi: 10.3346/jkms.2022.37.e335.

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.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Oral
  • Aged
  • Aged, 80 and over
  • Anticoagulants / therapeutic use
  • Atrial Fibrillation* / complications
  • Atrial Fibrillation* / drug therapy
  • Atrial Fibrillation* / epidemiology
  • Body Weight
  • Embolism* / complications
  • Embolism* / prevention & control
  • Factor Xa Inhibitors / adverse effects
  • Female
  • Hemorrhage / chemically induced
  • Humans
  • Kidney Diseases* / chemically induced
  • Male
  • Prospective Studies
  • Registries
  • Stroke* / epidemiology
  • Stroke* / etiology
  • Stroke* / prevention & control

Substances

  • Anticoagulants
  • edoxaban
  • Factor Xa Inhibitors

Associated data

  • ClinicalTrials.gov/NCT03554837