Table 2.
Stroke, systemic embolism, and major bleeding in patients with CHADS2 ≥3 in the pivotal trials.
| Direct Oral Anticoagulants | |||||||
|---|---|---|---|---|---|---|---|
| RCTs |
Pts on DOAC
(N) |
CHADS
2
≥3%
% (N) |
Stroke o SEE
CHADS 2 ≥3 % (N) |
MB
CHADS 2 ≥3%(N) |
RI efficacy | RI safety | |
| Warfarin | |||||||
| RCTs | Pts on WKA (N) |
CHADS2≥3 % (N) |
Stroke o SEE CHADS2 ≥3 % (N) |
MB CHADS2 ≥3 %(N) |
RIefficacy | RIsafety | |
| ROCKET AF2 | 7,131 | 87% (6,205) | 3.85% (239) | 5.4% (337) | 0.04 | 0.06 | |
| ARISTOTLE3 | 9,120 | 30.2% (2,758) | 3.40% (94) | 5.2% (143) | 0.11 | 0.17 | |
| RE-LY110 1 | 6,015 | 32.4% (1,951) | 4.2% (82) | 7.5% (147) | 0.12 | 0.23 | |
| RE-LY150 1 | 6,076 | 32.3% (1,965) | 3.76% (74) | 9.6% (188) | 0.11 | 0.30 | |
| ENGAGEHD 4 | 7,035 | 53.7% (3,784) | NA | NA | NA | NA | |
| ROCKET AF2 | 7,133 | 86.8% (6,197) | 4.35% (270) | 5.4% (337) | 0.05 | 0.06 | |
| ARISTOTLE3 | 9,081 | 30.2% (2,744) | 4.81% (132) | 6.9% (188) | 0.15 | 0.23 | |
| RE-LY110 – 150 1 | 6,022 | 31.7% (1,914) | 5.27% (101) | 9.0% (172) | 0.16 | 0.28 | |
| ENGAGEHD 4 | 7,036 | 52.3% (3,685) | NA | NA | NA | NA | |
CHADS2, [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke (double weight)]; RCTs, randomized controlled trials; DOAC, non-VKA antagonist drugs; N, number; Pts, patients; SEE, systemic embolism; MB, major bleeding; HD, higher dose; RIefficacy, Risk Index (rate of stroke–systemic embolism/rate of patients with CHADS2 ≥3; RIsafety, Risk Index (rate of major bleeding/rate of patients with CHADS2 ≥3); NA, not available.