Table 3.
Stroke, systemic embolism, and major bleeding in elderly patients (age ≥75 years) in the pivotal trials.
| Direct Oral Anticoagulants | ||||||
|---|---|---|---|---|---|---|
| RCTs | Pts on DOAC (N) |
≥75 years % (N) |
Stroke or SEE ≥75 years % (N) |
MB ≥75 years % (N) |
RIefficacy | RIsafety |
| Warfarin | ||||||
| RCTs | Pts on WKA (N) |
≥75 years % (N) |
Stroke or SEE ≥75 years % (N) |
MB ≥75 years % (N) |
RIefficacy | RIsafety |
| ROCKET AF2 | 7,131 | 43.8% (3,120) | 4.00% (125) | 7.15% (223) | 0.09 | 0.16 |
| ARISTOTLE3 | 9,120 | 31.2% (2,850) | 2.77% (79) | 5.3% (151) | 0.09 | 0.17 |
| RE-LY110 1 | 6,015 | 39.1% (2,349) | 3.7% (87) | 8.7% (204) | 0.09 | 0.22 |
| RE-LY150 1 | 6,076 | 40.6% (2,466) | 2.79% (69) | 9.97% (246) | 0.07 | 0.24 |
| ENGAGEHD 4 | 7,035 | 40.5 (2,838) | 5.00% (142) | 7.68% (218) | 0.12 | 0.19 |
| ROCKET AF2 | 7,133 | 43.6% (3,109) | 4.95% (154) | 6.56% (204) | 0.11 | 0.15 |
| ARISTOTLE3 | 9,081 | 31.1% (2,828) | 3.85% (109) | 7.9% (224) | 0.12 | 0.25 |
| RE-LY110–150 1 | 6,022 | 40.2% (2,423) | 4.17% (101) | 8.5% (206) | 0.1 | 0.21 |
| ENGAGEHD 4 | 7,036 | 39.8 (2,805) | 5.98.% (168) | 9.30% (261) | 0.15 | 0.23 |
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 aged ≥75 years); RIsafety, Risk Index (rate of major bleeding/rate of patients aged ≥75 years).