Table 4.
Stroke, systemic embolism, and major bleeding in patients with heart failure in the pivotal trials.
| Direct Oral Anticoagulants | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RCTs | Pts on DOAC (N) |
HF % (N) | Stroke o SEE HF % (N) |
MB HF % (N) |
RIefficacy | RIsafety | ||||||
| Warfarin | ||||||||||||
| RCTs | Pts on WKA (N) |
HF % (N) | Stroke o SEE HF % (N) |
MB HF % (N) |
RIefficacy | RI safety | ||||||
| ROCKET AF2 | 7,131 | 62% (4,467) | 3.67% (164) | 5.21% (233) | 0.05 | 0.084 | ||||||
| ARISTOTLE3 | 9,120 | 35.5% (3,235) | 2.10% (68) | 3.49% (227) | 0.06 | 0.098 | ||||||
| RE-LY110 1 | 6,015 | 32.2% (1,937) | 3.09% (60) | 5.31% (103) | 0.09 | 0.164 | ||||||
| RE-LY150 1 | 6,076 | 31.8% (1,934) | 2.32% (45) | 5.01% (97) | 0.072 | 0.157 | ||||||
| ENGAGEHD 4 | 7,035 | 58.2 (4,097) | 4.19% (172) | 5.54% (227) | 0.072 | 0.095 | ||||||
| ROCKET AF2 | 7,133 | 62.2% (4,441) | 4.0% (179) | 5.24% (233) | 0.064 | 0.084 | ||||||
| ARISTOTLE3 | 9,081 | 35.4% (3,216) | 2.7% (88) | 4.85% (156) | 0.076 | 0.14 | ||||||
| RE-LY110–150 1 | 6,022 | 31.9% (1,922) | 3.06% (59) | 6.24% (120) | 0.09 | 0.19 | ||||||
| ENGAGEHD 4 | 7,036 | 57.5% (4,048) | 4.8% (194) | 7.0% (285) | 0.083 | 0.12 | ||||||
RCTs, randomized controlled trials; DOAC, non-VKA antagonist drugs; N, number; Pts, patients; SEE, systemic embolism; HF, heart failure; MB, major bleeding; HD, higher dose; RIefficacy, Risk Index (rate of stroke–systemic embolism/rate of patients with heart failure); RIsafety, Risk Index (rate of major bleeding/rate of patients with heart failure).