Effectiveness and Safety of Edoxaban in the Routine Clinical Care of Atrial Fibrillation Patients in Brazil: Prospective 1-Year Follow-Up Study - EdoBRA.

Background: Edoxaban, an orally administered anticoagulant, has been shown to be safe and effective in preventing stroke in atrial fibrillation (AF) patients. Given its widespread use since approval, evaluating edoxaban's real-world performance in the Brazilian clinical context is crucial.

Objective: The study aimed to report the one-year safety and effectiveness of edoxaban in AF patients in Brazil.

Methods: EdoBRA is a multi-center, prospective, observational investigation conducted across 30 Brazilian research sites. Bleeding events were considered as safety measures and cardiovascular events were considered for effectiveness measures. Descriptive analyses were performed. Kaplan-Meier curves were generated for time-to-event analysis and a 95% confidence interval was used as appropriate.

Results: Among the 705 enrolled participants, 590 were included in the analysis for having at least one follow-up or one reported event. Mean (±SD) CHA2DS2-VASc risk score was 3 (3.3 ± 1.6) and the mean HAS-BLED risk score was 2 (1.8 ± 1.2). During the one-year follow-up period, nine major bleedings events were reported, including five cases of gastrointestinal bleeding (IP 0.85 [95% CI =0.82; 0.88]). Among the cardiovascular events recorded (N = 68), there were four stroke events (IP 0.68 [CI 95% 0.65;0.71]), one transient ischemic attack (IP 0.17 [CI 95% (0.16;0.18]) and 1 event was Venous Thromboembolic Events (IP 0.17 [CI 95% (0.16;0.18]). No systemic embolic event was exhibited by any patient.

Conclusion: In an elderly population with several comorbidities routinely treated with edoxaban for AF, the rates of cardiovascular event and major bleeding were low.