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. Author manuscript; available in PMC: 2023 Apr 15.
Published in final edited form as: Circ Res. 2022 Apr 14;130(8):1075–1094. doi: 10.1161/CIRCRESAHA.121.319947

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)