There is limited information on the use of antithrombotic therapies and their outcomes in Latin American patients with atrial fibrillation. This stands true in almost all aspects of medicine: large multicenter randomized studies rarely include Latin American countries, and when they do, the population included is not representative of the overall population.
The only exception are endemic diseases; for example, with the rise of the Zika virus, NEJM was filled with articles authored in Brazil. However, for all other medicine-related issues, most times we have to make do with data extrapolation.
The ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) global study compared the efficacy and safety of edoxaban vs. warfarin in patients with atrial fibrillation over a mean follow-up of 2.8 years. Authors compared the results of both drugs in 2661 Latin American patients vs. 18,444 patients from other regions.
Upon comparison of patients from Latin America and other regions, the overall risks for stroke, systemic embolism, and major bleeding were similar. However, Latin American patients experienced higher mortality rates and higher risk of intracranial bleeding.
When compared with warfarin, edoxaban reduced the risk of stroke/systemic embolism in patients from all regions (hazard ratio [HR]: 0.64 and 0.91 for Latin America and other regions, respectively), and it also reduced the risk of major bleeding (HR: 0.71 and 0.82, respectively), and cardiovascular death (HR: 0.78 and 0.88, respectively). There was no evidence of heterogeneity among regions.
On the other hand, there was greater reduction of hemorrhagic stroke with edoxaban in Latin America (HR: 0.16) compared with all other regions (HR: 0.64; p for interaction = 0.037).
Conclusion
Latin American patients with atrial fibrillation have higher risk of intracranial bleeding and death compared with patients from other regions. However, although event rates were higher for Latin American patients, outcomes with edoxaban vs. warfarin were at least as favorable in them as in patients from the rest of the world, with an even greater reduction in hemorrhagic stroke in Latin American patients. Edoxaban presents an appealing alternative to warfarin in patients with atrial fibrillation for the prevention of morbidity and mortality related with arterial thromboembolism and anticoagulant agent-related bleeding.
Original title: Edoxaban Versus Warfarin in Latin American Patients with Atrial Fibrillation. The ENGAGE AF-TIMI 48 Trial.
Reference: Ramón Corbalán et al. J Am Coll Cardiol 2018;72:1466-75.
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