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

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:72

Article

Corbalan, Ramon¹  Carlos Nicolau, Jose²  Lopez-Sendon, Jose³  Garcia-Castillo, Armando⁴  Botero, Rodrigo⁵  Sotomora, Gustavo⁶  Horna, Manuel⁷  Ruff, Christian T.⁸  Hamershock, Rose A.⁸  Grip, Laura T.⁸  Antman, Elliott M.⁸  Braunwald, Eugene⁸  Giugliano, Robert P.⁸ 

[1] Pontificia Univ Catolica Chile, Escuela Med, Div Cardiovasc, Santiago, Chile

[2] Univ Sao Paulo, Fac Med, Hosp Clin, Inst Coracao, Sao Paulo, Brazil

[3] Hosp Univ La Paz, IdiPaz, Madrid, Spain

[4] Cardiolink Clin Trials SC, Monterrey, Mexico

[5] Clin Medellin, Medellin, Colombia

[6] Edificio Clin Med, Ciudad De Guatemala, Guatemala

[7] Inst Med Miraflores, Lima, Peru

[8] Harvard Med Sch, Brigham & Womens Hosp, Cardiovasc Div, TIMI Study Grp, Boston, MA USA

关键词: anticoagulation;    atrial fibrillation;    edoxaban;    Latin America;   

DOI  :  10.1016/j.jacc.2018.07.037

来源: Elsevier

【 摘 要 】

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 (p(int) = 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; p(int) = 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. (C) 2018 Published by Elsevier on behalf of the American College of Cardiology Foundation.

【 授权许可】

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