Table 3.
Descriptive analysis of events by trial and region and adjusted event rates per 100 patients per year
| Characteristic | Type of direct oral anticoagulant, trial events (%/year) | Total* %/year | ||||
|---|---|---|---|---|---|---|
| Dabigatran RE‐LY | Rivaroxaban ROCKET AF | Apixaban ARISTOTLE | Edoxaban ENGAGE AF | Rivaroxaban J ROCKET | ||
| Stroke/SEE | ||||||
| Direct oral anticoagulants | ||||||
| Europe pooled, n (%) | 111 (1.4) | 140 (2.4) | 75 (1.2) | 104 (1.4) | — | 1.6 (1.1–2.1) |
| Western Europe | 80 (1.5) | 40 (2.4) | 30 (0.9) | 37 (1.6) | — | 1.6 (1.1–2.1) |
| Eastern Europe | 31 (1.3) | 100 (2.4) | 45 (1.4) | 67 (1.3) | — | 1.6 (1.1–2.1) |
| Other regions pooled, n (%) | 206 (1.6) | 129 (2.5) | 137 (1.5) | 78 (1.0) | 22 (2.5) | 1.7 (1.2–2.2) |
| North America | 103 (1.4) | 47 (2.2) | 42 (1.1) | 23 (0.7) | — | 1.3 (0.8–1.9) |
| Latin America | 15 (1.4) | 37 (2.5) | 43 (1.4) | 20 (1.0) | — | 1.6 (1.0–2.2) |
| Asia Pacific, other | 88 (2.0) | 45 (2.7) | 52 (2.1) | 35 (1.4) | 22 (2.5) | 2.1 (1.7–2.5) |
| Warfarin | ||||||
| Europe pooled, n (%) | 58 (1.4) | 157 (2.6) | 77 (1.2) | 93 (1.2) | — | 1.6 (1.0–2.3) |
| Western Europe | 45 (1.6) | 43 (2.6) | 25 (0.8) | 25 (1.1) | — | 1.4 (0.8–2.2) |
| Eastern Europe | 13 (1.0) | 114 (2.6) | 52 (1.7) | 68 (1.3) | — | 1.7 (1.0–2.4) |
| Other regions pooled, n (%) | 144 (2.1) | 149 (2.8) | 188 (2.1) | 139 (1.8) | 26 (3.1) | 2.3 (1.9–2.7) |
| North America | 67 (1.7) | 50 (2.3) | 56 (1.5) | 42 (1.2) | — | 1.7 (1.3–2.1) |
| Latin America | 9 (1.6) | 45 (3.0) | 52 (1.8) | 42 (2.1) | — | 2.2 (1.6–2.8) |
| Asia Pacific, other | 68 (3.0) | 54 (3.2) | 80 (3.2) | 55 (2.2) | 26 (3.1) | 2.9 (2.5–3.4) |
| Major bleeding | ||||||
| Direct oral anticoagulants | ||||||
| Europe pooled, n (%) | 180 (2.3) | 137 (2.3) | 110 (1.7) | 150 (2.0) | — | 2.1 (1.8–2.4) |
| Western Europe | 131 (2.5) | 49 (3.0) | 74 (2.3) | 71 (3.0) | — | 2.6 (2.3–3.0) |
| Eastern Europe | 49 (2.0) | 88 (2.0) | 36 (1.1) | 79 (1.5) | — | 1.7 (1.3–2.1) |
| Other regions pooled, n (%) | 561 (4.4) | 258 (4.9) | 217 (2.3) | 268 (3.4) | 23 (2.6) | 3.5 (2.6–4.6) |
| North America | 403 (5.4) | 149 (7.1) | 106 (2.7) | 135 (3.9) | — | 4.7 (3.1–6.5) |
| Latin America | 26 (2.4) | 46 (3.1) | 60 (2.0) | 48 (2.5) | — | 2.5 (2.0–3.0) |
| Asia Pacific, other | 132 (3.0) | 63 (2.9) | 51 (2.0) | 85 (3.4) | 23 (2.6) | 3.0 (2.4–3.6) |
| Warfarin | ||||||
| Europe pooled, n (%) | 104 (2.6) | 153 (2.5) | 135 (2.2) | 206 (2.7) | — | 2.5 (2.3–2.7) |
| Western Europe | 80 (2.9) | 69 (4.1) | 77 (2.5) | 86 (3.6) | — | 3.2 (2.6–4.0) |
| Eastern Europe | 24 (1.9) | 84 (1.9) | 58 (1.9) | 120 (2.3) | — | 2.1 (1.8–2.3) |
| Other regions pooled, n (%) | 317 (4.7) | 233 (4.4) | 327 (3.6) | 318 (4.0) | 27 (3.2) | 4.1 (3.6–4.6) |
| North America | 209 (5.4) | 111 (5.2) | 137 (3.7) | 152 (4.4) | — | 4.6 (3.9–5.5) |
| Latin America | 17 (3.0) | 41 (2.7) | 94 (3.2) | 67 (3.4) | — | 3.2 (2.8–3.6) |
| Asia Pacific, other | 91 (4.0) | 81 (4.8) | 96 (3.9) | 99 (4.0) | 27 (3.2) | 4.1 (3.7–4.5) |
SEE, systemic embolic events.
*
Proportion meta‐analysis, random effects model, StatsDirect software.