Real-World Outcomes of Patients With Non-Valvular Atrial Fibrillation on Anticoagulants Ineligible for Phase III Trials of Direct Oral Anticoagulants　- A Retrospective Cohort Study.

ABSTRACT:

Background

Many patients with non-valvular atrial fibrillation (NVAF) on direct oral anticoagulants (DOACs) in real-world practice were ineligible for DOAC phase III trials. We aimed to determine the proportion of Japanese patients with NVAF eligible for these trials and compare the characteristics and outcomes of ineligible and eligible patients to determine the generalizability of the trial results.

Methods and results

This retrospective cohort study included 7,826 Japanese NVAF patients on warfarin from 71 hospitals. We assessed trial eligibility and analyzed outcomes (major bleeding, stroke/systemic embolism, all-cause mortality) using Cox proportional hazards models. Nearly half (48.2%; n=3,772) of the patients were ineligible for DOAC phase III trials. Ineligible patie

SUBMITTER: Higa M 

PROVIDER: S-EPMC12510964 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature