Background: We hypothesized that the clinical characteristics and outcomes of Latin American patients with AF enrolled in a global trial may be different from the rest of the world (ROW).
Methods: A total of 14,264 patients from 45 countries were enrolled in ROCKET AF, which compared rivaroxaban with warfarin in patients with atrial fibrillation (AF). Of these, 1878 (13.2%) were from 7 Latin American countries. The clinical characteristics and outcomes (adjusted by baseline characteristics) of these patients were compared with 12,293 patients from the ROW. We also compared treatment outcomes of rivaroxaban vs. warfarin stratified by region.
Results: When compared with ROW, Latin American patients were older (75 vs. 72 yrs), had higher CHADS2 scores (3.6 vs. 3.5), more permanent AF (91 vs. 79%), and lower creatinine clearance (62 vs. 68 mL/min) (all p<0.001). Prior MI was less frequent in Latin American patients (11 vs. 18%), with similar rates of beta-blocker use at baseline (56 vs. 66%). Mean TTRs were similar in both groups (58%). The rate of stroke/SE was similar in Latin American patients (p=0.63), but all-cause and vascular death were significantly higher than in ROW (HR 1.40, 95% CI 1.20-164 and HR 1.38, 95% CI 1.14-1.68; p<0.001). Rates of major or NMCR bleeding, however, were lower (HR 0.89, 95% CI 0.80-1.0; p <0.05) (Figure). Rates of stroke/SE were similar with rivaroxaban and warfarin in Latin American patients and ROW, but Latin American patients had a higher risk of vascular death (p for interaction=0.032) and lower rates of NMCR bleeding with rivaroxaban than with warfarin.
Conclusion: Latin American patients with AF had a higher burden of risk factors and poorer outcomes than patients from ROW, despite adjustment for baseline characteristics. Clinical outcomes with rivaroxaban compared with warfarin were at least as favorable in Latin American patients as in the ROW.