Observational studyArquivos brasileiros de cardiologia2025
Effectiveness and Safety of Edoxaban in the Routine Clinical Care of Atrial Fibrillation Patients in Brazil: Prospective 1-Year Follow-Up Study - EdoBRA.
Observational study in Arquivos brasileiros de cardiologia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Challenges in Performing Real-World Evidence Studies in Low-Middle Income Countries: the EdoBRA Study.Arquivos brasileiros de cardiologia · 2025Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEdoxaban, 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.
objectiveThe study aimed to report the one-year safety and effectiveness of edoxaban in AF patients in Brazil.
methodsEdoBRA 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.
resultsAmong 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.
conclusionIn an elderly population with several comorbidities routinely treated with edoxaban for AF, the rates of cardiovascular event and major bleeding were low.
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