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

Area of Science:

• Cardiology
• Pharmacology

Background:

• Non-vitamin K antagonist oral anticoagulants (NOACs) offer effective thromboembolism prevention with reduced bleeding risk compared to warfarin.
• Limited data exists on the outcomes of on-label reduced-dose NOACs.
• This study focuses on the safety and efficacy of reduced-dose edoxaban in atrial fibrillation (AF) patients.

Purpose of the Study:

• To assess the safety and efficacy of on-label reduced-dose edoxaban in patients with atrial fibrillation.
• To evaluate major bleeding, stroke or systemic embolism, and all-cause death rates.
• To analyze composite clinical outcomes in this patient population.

Main Methods:

• A multi-center, prospective, non-interventional study design.
• Inclusion of 2,448 patients with atrial fibrillation.
• Evaluation of safety and efficacy endpoints including major bleeding, thromboembolic events, and mortality.

Main Results:

• The study included 2,448 patients (mean age 75.0 years).
• Major bleeding occurred at 1.34%/yr, stroke/systemic embolism at 1.13%/yr, and net clinical outcomes at 3.19%/yr.
• No significant differences in outcomes were observed based on dose reduction criteria, renal dysfunction, or body weight; however, higher bleeding risk scores (HAS-BLED) were associated with increased composite clinical outcomes.

Conclusions:

• Reduced-dose edoxaban is safe and effective in Asian AF patients, particularly those with severe renal dysfunction or low body weight.
• The findings support the use of reduced-dose edoxaban in specific patient subgroups.
• Physicians must remain vigilant in assessing bleeding risk, even when prescribing lower-dose anticoagulant regimens.