Table 2.
Major atrial fibrillation stroke prevention trials
Study | Patient population | Comparator groups | Stroke or systemic embolism | Major hemorrhage |
---|---|---|---|---|
RE-LY (open label) | Mean age 71 years Mean CHADS2 2.1 Mean TTR 64% History of Stroke or TIA 20% |
Dabigatran 150 mg Dabigatran 110 mg Warfarin |
Dabigatran 150 vs. warfarin: RR 0.66 95% CI 0.53–0.82 Dabigatran 110 vs. warfarin: RR 0.91 95% CI 0.74–1.11 |
Dabigatran 150 vs. warfarin: RR 0.93 95% CI 0.81–1.07 Dabigatran 110 vs. warfarin: RR 0.80 95% CI 0.69–0.93 |
ROCKET-AF (Randomized controlled) | Mean age 73 years Mean CHADS2 3.5 Mean TTR 55% History of Stroke, systemic embolism or TIA 55% |
Rivaroxaban 20 mg Warfarin |
HR 0.88 95% CI 0.75–1.03 | HR 0.69 95% CI 0.90–1.20 |
ARISTOTLE (Randomized controlled) | Mean age 70 years Mean CHADS2 2.1 Mean TTR 62% History of Stroke |
Apixaban 5 mg Warfarin |
HR 0.79 95% CI 0.66–0.95 | HR 0.69 95% CI 0.60–0.80 |
ENGAGE (Randomized controlled) | Median age 72 years Mean CHADS2 2.8 Median TTR 68% History of Stroke or TIA 28% |
Edoxaban 60 mg Edoxaban 30 mg Warfarin |
Edoxaban 60 vs. warfarin: HR 0.79 95% CI 0.63–0.99 Edoxaban 30 vs. warfarin: HR 1.07 95% CI 0.87–1.31 |
Edoxaban 60 vs. warfarin: HR 0.80 95% CI 0.71–0.91 Edoxaban 30 vs. warfarin: HR 0.47 95% CI 0.41–0.55 |
AVEROES (Randomized controlled) | Mean age 70 years Mean CHADS2 2.0 History of Stroke or TIA 14% |
Apixaban 5 mg Aspirin 81–324 mg |
HR 0.45 95% CI 032–0.62 | HR 1.13 95% CI 0.74–1.75 |
PREVAIL-AF and PROTECT-AF – 5 year follow up | Mean age 73 years Mean CHADS2 2.3 Mean TTR 62% History of Stroke or TIA 23% |
WATCHMAN Warfarin |
HR 0.96 95% 0CI 0.60–1.54 | HR 0.91 95% CI 0.64–1.29 (Including procedural bleeding) HR 0.48 95% CI 0.32–0.71 (Excluding procedural bleeding) |