Table 3.
Atrial fibrillation | Drug | Comparison | Primary end point: stroke and systemic embolism | ICH rate (% per year) | Major bleeding event (% per year) |
---|---|---|---|---|---|
RE-LY14 | Dabigatran 150 mg BID or 110mg BID | Dose-adjusted warfarin | 1.71% warfarin 1.54% dabigatran 110mg (P = 0.34) 1.11% dabigatran 150 mg (P< 0.001) | 0.74% warfarin 0.23% dabigatran 110mg (P< 0.001) 0.3% dabigatran 150 mg (P< 0.001) | 3.57% warfarin 2.87% dabigatran 110mg (P = 0.003) 3.32% dabigatran 150 mg (P=0.31) |
ROCKET AF9 | Rivaroxaban 20 mg once a day | Dose-adjusted warfarin | 2.42% warfarin 2.12% rivaroxaban (P=0.117) | 0.74% warfarin 0.49% rivaroxaban (P= 0.019) | 3.45% warfarin 3.6% rivaroxaban (P= 0.576) |
ARISTOTLE16 | Apixaban 5 mg BID | Dose-adjusted warfarin | 1.60 warfarin 1.27% apixaban (P< 0.001) | 0.47% warfarin 0.24% apixaban | 3.09% warfarin 2.13% apixaban (P< 0.001) |
AVERROES19 | Apixaban 5 mg BID | Aspirin (81–324 mg daily) | 3.9% aspirin 1.7% apixaban (P< 0.001) | 0.3% aspirin 0.4% apixaban (P=0.83) | 1.2% aspirin 1.4% apixaban (P=0.33) |
RE-LY, Randomized Evaluation of Longterm Anticoagulant Therapy; ROCKET-AF, Rivaroxaban Once daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation; ARISTOTLE, Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; AVERROES, Apixaban versus aspirin to reduce the risk of stroke; mg, milligram; BID, twice a day.