Abstract W P147: Apixaban Versus Warfarin in Patients with Atrial Fibrillation: Patient Characteristics of the Latin America Cohort from a Multinational Clinical Trial

Abstract

Introduction: Apixaban, a novel oral direct factor Xa inhibitor has clearly demonstrated clinical benefit in stroke or systemic embolism (SE) reduction without impacting the risk of major bleeding or intracranial hemorrhage in patients with atrial fibrillation (AF). Here we present the patient characteristics of the Latin American cohort (patients from Argentina, Brazil, Chile, Colombia, Mexico, Peru and Puerto Rico) relative to the overall clinical trial population. Methods: Patients with AF who also had at least one risk factor for stroke were randomized to receive apixaban (at a dose of 5 mg twice daily) or warfarin (target international normalized ratio, 2.0 to 3.0) in a double blind clinical trial. The study recruited from 39 countries from December 2006 through April 2010. Of the 36 countries seven were from the Latin America region: Argentina, Brazil, Chile, Colombia, Mexico, Peru, and Puerto Rico. Patient characteristics from the Latin American (LA) cohort, is presented relative to the patient characteristics of the overall trial population. Results: There were 18,201 patients in the study, of which 3,468 were from Latin America which comprised approximately 19% of the trial population. The median age was similar between the LA cohort and the total study population, 71 (IQR 64-77) and 70 (IQR 63-76) respectively. The majority of patients were male, 60.2 and 64.7% for the LA and total study populations respectively. At enrollment, 14% of the LA cohort had a previous stroke, transient ischemic attack, or systemic embolism and 19% in the overall trial population. Mean CHADS2 score at enrollment for the LA cohort was 2.1±1.1, which is the same as the overall population. When region subgroup analysis was performed, there was no statistically significant (p> 01.0) interactions between treatment effects and geographic region. Conclusions: Baseline demographic and disease characteristics data from the LA cohort are relatively similar to that of the clinical trial population for the LA cohort. Results, in terms of safety and efficacy, given the total population trial, are expected to be consistent since interaction between treatment effects and geography was not significant.