Table 2.
Results of Trials of DOACs for Stroke Prevention in NVAF (Latin American Subgroups).a
| RE-LY Dabigatran 110 mg BID46 | RE-LY Dabigatran 150 mg BID46 | ROCKET AF Rivaroxaban 20 mg QD48 | ENGAGE AF–TIMI 48 Edoxaban 30 mg QD45 | ENGAGE AF–TIMI 48 Edoxaban 60 mg QD45 | ARISTOTLE Apixaban 5 mg BID47 | |
|---|---|---|---|---|---|---|
| Comparator | Warfarin target INR, 2.0-3.0 | Warfarin target INR, 2.0-3.0 | Warfarin target INR, 2.0-3.0 | Warfarin target INR, 2.0-3.0 | Warfarin target INR, 2.0-3.0 | Warfarin target INR, 2.0-3.0 |
| Total N | 18 113 | 14 264 | 21 105 | 18 201 | ||
| Latin American patients (n) | 1134 (South America; ITT, both efficacy and safety) | 1878 (ITT); 1877 (SOT) | 2661 (ITT); 2651 (SOT) | 3468 (ITT); 3460 (SOT) | ||
| Efficacy | ||||||
| Stroke or systemic embolism | 1.82 vs 1.68 | 0.91 vs 1.68 | 3.9 vs 4.8 | 2.15 vs 2.50 | 1.61 vs 2.50 | 1.4 vs 1.8 |
| Safety | ||||||
| Major bleeding | 1.66 vs 3.74 | 2.65 vs 3.74 | 2.1 vs 3.5 | |||
| Major and CRNM bleeding | 17.78 vs 19.72 | |||||
Abbreviations: BID, twice daily; CRNM, clinically relevant nonmajor; DOAC, direct oral anticoagulant; INR, international normalized ratio; ITT, intent to treat; NVAF, nonvalvular atrial fibrillation; QD, once daily; SOT, safety on-treatment.
aAll columns show DOAC versus warfarin. All data are presented as annual rates per 100 patients.