Table 3 Clinical outcomes
EINSTEIN-DVT | EINSTEIN-PE | EINSTEIN pooled | ||||
|---|---|---|---|---|---|---|
Outcome | Rivaroxaban | Enoxaparin/VKA | Rivaroxaban | Enoxaparin/VKA | Rivaroxaban | Enoxaparin/VKA |
Efficacy | ||||||
Intention-to-treat population–N | 1731 | 1718 | 2419 | 2413 | 4150 | 4131 |
First recurrent VTE–n (%) | 36 (2.1) | 51 (3.0) | 50 (2.1) | 44 (1.8) | 86 (2.1) | 95 (2.3) |
Fatal PE | 0 | 0 | 2 | 1 | 2 (<0.1) | 1 (<0.1) |
Death (PE cannot be excluded) | 2 | 6 | 8 | 5 | 10 (0.2) | 11 (0.3) |
DVT and PE | 1 | 0 | 0 | 2 | 1 (<0.1) | 2 (<0.1) |
DVT only | 14 | 28 | 18 | 17 | 32 (0.8) | 45 (1.1) |
PE only | 19 | 17 | 22 | 19 | 41 (1.0) | 36 (0.9) |
Death from any cause–n (%) | 38 (2.2) | 49 (2.9) | 58 (2.4) | 50 (2.1) | 96 (2.3) | 99 (2.4) |
PE/PE not ruled out | 4 | 6 | 11 | 7 | 15 (0.4) | 13 (0.3) |
Bleeding | 1 | 5 | 5 | 4 | 6 (0.1) | 9 (0.2) |
Cardiovascular | 2 | 4 | 10 | 3 | 12 (0.3) | 7 (0.2) |
Other | 31 | 34 | 32 | 36 | 63 (1.5) | 70 (1.7) |
Safety | ||||||
N | 1718 | 1711 | 2412 | 2405 | 4130 | 4116 |
First major plus nonmajor clinically relevant bleeding event–n (%) | 139 (8.1) | 138 (8.1) | 249 (10.3) | 274 (11.4) | 388 (9.4) | 412 (10.0) |
First major bleeding event–n (%) | ||||||
Any | 14 (0.8) | 20 (1.2) | 26 (1.1) | 52 (2.2) | 40 (1.0) | 72 (1.7) |
Fatal bleeding | 1 (<0.1) | 5 (0.3) | 2 (<0.1) | 3 (0.1) | 3 (<0.1) | 8 (0.2) |
Retroperitoneal | 0 | 0 | 0 | 1 (<0.1) | 0 | 1 (<0.1) |
Intracranial | 0 | 2 (0.1) | 2 (<0.1) | 2 (<0.1) | 2 (<0.1) | 4 (<0.1) |
GI/thorax | 1 (<0.1) | 3 (0.2) | 0 | 0 | 1 (<0.1) | 3 (<0.1) |
Nonfatal in a critical site* | 3 (0.2) | 3 (0.2) | 7 (0.3) | 26 (1.1) | 10 (0.2) | 29 (0.7) |
Retroperitoneal | 0 | 1 (<0.1) | 1 (<0.1) | 6 (0.2) | 1 (<0.1) | 7 (0.2) |
Intracranial | 2 (0.1) | 0 | 1 (<0.1) | 9 (0.4) | 3 (<0.1) | 9 (0.2) |
Intraocular | 1 (<0.1) | 0 | 2 (<0.1) | 2 (<0.1) | 3 (<0.1) | 2 (<0.1) |
Pericardial | – | – | 0 | 2 (<0.1) | 0 | 2 (<0.1) |
Intra-articular | 0 | 1 (<0.1) | 0 | 3 (0.1) | 0 | 4 (<0.1) |
Adrenal/pulmonary/abdominal | – | – | 3 (<0.1) | 2 (<0.1) | 3 (<0.1) | 2 (<0.1) |
Nonfatal, noncritical site but associated with a fall in hemoglobin ≥2 g/dl and/or transfusions ≥2 units | 10 (0.6) | 12 (0.7) | 17 (0.7) | 25 (1.0) | 27 (0.7) | 37 (0.9) |
Nonmajor clinically relevant bleeding–n (%)† | 126 (7.3) | 119 (7.0) | 228 (9.5) | 227 (9.4) | 354 (8.6) | 346 (8.4) |