Outcome | Dabigatran 220 mg | Enoxaparin | Risk difference vs. enoxaparin, % | p value |
---|---|---|---|---|
(n = 2,156) | (n = 2,157) | (95 % CI) | ||
Bleeding Events | ||||
Major, Total no. patients, % (95 % CI)a | 37 (1.7, 1.2-2.4 %) | 27 (1.3, 0.8-1.8 %) | 0.5 % (–0.2, 1.2) | 0.20 |
Fatal | 1 (0.05) | 0 (0) | ||
In a critical organ | 2 (0.1) | 0 (0) | ||
Clinically overt associated with 20 g/L or more fall in hemoglobin | 31 (1.4) | 19 (0.9) | ||
Clinically overt leading to transfusion of two or more units of packed cells or whole blood | 33 (1.5) | 22 (1.0) | ||
Warranting treatment cessation | 1 (0.05) | 1 (0.05) | ||
Leading to re-operation | 2 (0.1) | 3 (0.1) | ||
Onset of events – No. events/total no. patients (%) | ||||
-Before the first oral dose | 19/37 (51.4) | 10/28 (35.7) | ||
-After the first oral dose | 18/37 (48.6) | 18/28 (64.3) | ||
Clinically relevant non-major bleeding | 71 (3.3) | 60 (2.8) | ||
Major or clinically relevant non-major bleeding | 108 (5.0) | 87 (4.0) | 1.0 % (–0.3, 2.2) | 0.13 |
Minor bleeding | 131 (6.1) | 128 (5.9) | ||
Any bleeding events | 239 (11.1) | 215 (10.0) | ||
Patients receiving blood transfusions - n/N (%) | 858/2,138 (40.1) | 880/2,134 (41.2) |