Trial | N | Baseline characteristics of trial participants | Trial details | Median follow-up |
Mean CHADS2 score | Percent on aspirin | Study drug (DOAC) and dose | Comparison | Mean percent time in INR range |
RE-LY | 18,113 | 2.1 | 40% | Dabigatran 110 mg twice daily or 150 mg twice daily | Warfarin (target INR 2.0 to 3.0) | 64% | 2 years |
ROCKET-AF | 14,264 | 3.5 | 36% | Rivaroxaban 20 mg once daily* | Warfarin (target INR 2.0 to 3.0) | 55% | 1.9 years |
ARISTOTLE | 18,201 | 2.1 | 31% | Apixaban 5 mg twice daily¶ | Warfarin (target INR 2.0 to 3.0) | 62% | 1.8 years |
ENGAGE AF-TIMI 48 | 21,105 | 2.8 | 29% | EdoxabanΔ 30 mg once daily or 60 mg once daily | Warfarin (target INR 2.0 to 3.0) | 65% | 2.8 years |
Trial | Event rates◊ for key outcomes |
Death | Stroke or systemic embolic event | Hemorrhagic stroke | Major bleeding§ |
DOAC | Warfarin | Relative effect (95% CI) | DOAC | Warfarin | Relative effect (95% CI) | DOAC | Warfarin | Relative effect (95% CI) | DOAC | Warfarin | Relative effect (95% CI) |
RE-LY | 110 mg | 3.75 | 4.13 | RR 0.91 (0.8-1.03) | 1.53 | 1.69 | RR 0.91 (0.74-1.11) | 0.12 | 0.38 | RR 0.31 (0.17-0.56) | 2.71 | 3.36 | RR 0.80 (0.69-0.93) |
150 mg | 3.64 | 4.13 | RR 0.88 (0.77-1.00) | 1.11 | 1.69 | RR 0.66 (0.53-0.82) | 0.10 | 0.38 | RR 0.26 (0.14-0.49) | 3.11 | 3.36 | RR 0.93 (0.81-1.07) |
ROCKET-AF | 4.5 | 4.9 | HR 0.92 (0.82-1.03) | 2.1 | 2.4 | HR 0.88 (0.75-1.03) | 0.26 | 0.44 | HR 0.59 (0.37-0.93)¥ | 3.6 | 3.4 | HR 1.04 (0.9-1.2)¥ |
ARISTOTLE | 3.52 | 3.94 | HR 0.89 (0.80-0.998) | 1.27 | 1.60 | HR 0.79 (0.66-0.95) | 0.24 | 0.47 | HR 0.51 (0.35-0.75) | 2.13 | 3.09 | HR 0.69 (0.6-0.8) |
ENGAGE AF-TIMI 48 | 30 mg | 3.80 | 4.35 | HR 0.87 (0.79-0.96) | 2.04 | 1.80 | HR 1.13 (0.96-1.34) | 0.16 | 0.47 | HR 0.33 (0.22-0.50) | 1.61 | 3.43 | HR 0.47 (0.41-0.55) |
ENGAGE AF-TIMI 48 | 60 mg | 3.99 | 4.35 | HR 0.92 (0.83-1.01) | 1.57 | 1.80 | HR 0.87 (0.73-1.04) | 0.26 | 0.47 | HR 0.54 (0.38-0.77) | 2.75 | 3.43 | HR 0.80 (0.71-0.91) |
Combined results‡ | 6.90 | 7.68 | RR 0.90 (0.85-0.95) | 3.11 | 3.79 | RR 0.81 (0.73-0.91) | 0.44 | 0.90 | RR 0.49 (0.38-0.64) | 5.26 | 6.17 | RR 0.86 (0.73-1.0) |