Table 2.
Crude incidences of recurrent VTE and major bleeding in patients receiving rivaroxaban, placebo, or aspirin according to baseline risk factor profiles
| Risk factor profile | EINSTEIN EXTENSION | EINSTEIN CHOICE | EINSTEIN CHOICE | EINSTEIN EXTENSION and EINSTEIN CHOICE | EINSTEIN EXTENSION | EINSTEIN CHOICE |
|---|---|---|---|---|---|---|
| Rivaroxaban 20 mg (n = 598) | Rivaroxaban 20 mg (n = 1107) | Rivaroxaban 10 mg (n = 1127) | All rivaroxaban (n = 2832) | Placebo (n = 590) | Aspirin (n = 1131) | |
| Unprovoked, n (%) | 252 (42.1) | 441 (39.8) | 480 (42.6) | 1173 (41.4) | 243 (41.1) | 468 (41.4) |
| Recurrent VTE | 4 (1.6) | 8 (1.8) | 7 (1.5) | 19 (1.6) | 20 (8.2) | 26 (5.6) |
| Major bleeding | 2 (0.8) | 4 (0.9) | 2 (0.4) | 8 (0.7) | 0 (0.0) | 1 (0.2) |
| Provoked by major persistent risk factor, n (%) | 19 (3.2) | 35 (3.2) | 28 (2.5) | 82 (2.9) | 26 (4.4) | 39 (3.4) |
| Recurrent VTE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.8) | 2 (5.1) |
| Major bleeding | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (5.1) |
| Provoked by minor persistent risk factors, n (%) | 246 (41.1) | 476 (43.0) | 462 (41.0) | 1184 (41.8) | 248 (42.0) | 466 (41.2) |
| Recurrent VTE | 4 (1.6) | 8 (1.7) | 6 (1.3) | 18 (1.5) | 17 (6.9) | 18 (3.9) |
| Major bleeding | 1 (0.4) | 1 (0.2) | 0 (0.0) | 2 (0.2) | 0 (0.0) | 0 (0.0) |
| Provoked by minor transient risk factors, n (%) | 63 (10.5) | 104 (9.4) | 101 (9.0) | 268 (9.5) | 56 (9.5) | 121 (10.7) |
| Recurrent VTE | 0 (0.0) | 1 (1.0) | 0 (0.0) | 1 (0.4) | 4 (7.1) | 4 (3.3) |
| Major bleeding | 0 (0.0) | 1 (1.0) | 2 (2.0) | 3 (1.1) | 0 (0.0) | 0 (0.0) |
| Provoked by major transient risk factor, n (%) | 18 (3.0) | 51 (4.6) | 56 (5.0) | 125 (4.4) | 17 (2.9) | 37 (3.3) |
| Recurrent VTE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Major bleeding | 1 (5.6) | 0 (0.0) | 1 (1.8) | 2 (1.6) | 0 (0.0) | 0 (0.0) |