# Edoxaban versus warfarine bij Latijns-Amerikaanse AF-patiënten: ENGAGE AF-TIMI 48

*geplaatst 2018-09-25 · Atriumfibrilleren · Journal of the American College of Cardiology · doi 10.1016/j.jacc.2018.07.037 · https://hartvaat.nl/2018/09/25/edoxaban-versus-warfarine-bij-latijns-amerikaanse-af-patienten-engage-af-timi-48/*

ENGAGE AF-TIMI 48 subanalyse bij Latijns-Amerikaanse patiënten met AF. Onderzoekt de regionale generaliseerbaarheid van edoxaban.

## English: Edoxaban Versus Warfarin in Latin American Patients With Atrial Fibrillation: The ENGAGE AF-TIMI 48 Trial.

This ENGAGE AF-TIMI 48 subanalysis in Latin American AF patients showed that edoxaban maintains its favorable efficacy and safety profile in this regional population, supporting the generalizability of the DOAC evidence.

## Abstract (original, from the publication)

BACKGROUND: There is limited information about the use of antithrombotic therapies and outcomes of Latin American (LatAm) subjects with atrial fibrillation. The global ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial compared the efficacy and safety of edoxaban versus warfarin over a median follow-up of 2.8 years. OBJECTIVES: The authors aimed to compare adjusted outcomes in Latin America versus outside Latin America and to compare outcomes stratified by anticoagulant treatment and region. METHODS: The authors analyzed clinical characteristics and outcomes, adjusted for baseline characteristics, the Human Development Index, and randomized treatment of 2,661 LatAm versus 18,444 non-Latin American subjects (nLAS). RESULTS: When compared with nLAS, LatAm subjects had a similar overall risk for stroke. After multivariate adjustment, the risks of stroke/systemic embolism (hazard ratio [HR]: 1.19; 95% confidence interval (CI): 0.96 to 1.47; p = 0.11) and major bleeding (HR: 1.10; 95% CI: 0.89 to 1.36; p = 0.39) were similar in LatAm and nLAS. LatAm subjects were at higher adjusted risk of death (HR: 1.48; 95% CI: 1.30 to 1.69; p < 0.001) and intracranial hemorrhage (ICH) (HR: 1.55; 95% CI: 1.00 to 2.41; p = 0.049). In both regions, when compared with warfarin, edoxaban reduced stroke/systemic embolism (HR: 0.64 and 0.91 in LatAm and nLAS, respectively), major bleeding (HR: 0.71 and 0.82), and cardiovascular death (HR: 0.78 and 0.88), without evidence of regional heterogeneity (pint = 0.41, 0.50, and 0.70, respectively). There was a greater reduction in hemorrhagic stroke with edoxaban in LatAm (HR: 0.16) than in nLAS (HR: 0.64; pint = 0.037). CONCLUSIONS: After multivariable adjustment, LatAm subjects with atrial fibrillation had higher rates of intracranial hemorrhage and death than nLAS. Outcomes with higher-dose edoxaban versus warfarin were at least as favorable in LatAm subjects as in nLAS, with an even greater reduction in hemorrhagic stroke seen in LatAm.

Auteurs: Ramón Corbalán, José Carlos Nicolau, José López-Sendon, Armando Garcia-Castillo, Rodrigo Botero, Gustavo Sotomora, Manuel Horna, Christian T Ruff, Rose A Hamershock, Laura T Grip, Elliott M Antman, Eugene Braunwald, Robert P Giugliano

---
Bron: Journal of the American College of Cardiology, https://doi.org/10.1016/j.jacc.2018.07.037. Bijgewerkt 2026-07-03T13:26:44Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.