Table 2 Efficacy outcomes, modified ITT population. Data are given as n/N (%)
Outcome | Dabigatran 220 mg | Enoxaparin 40 mg | Risk difference vs. enoxaparin, % (95 % CI)a | p value |
|---|---|---|---|---|
Total VTE and all-cause mortality | ||||
Pooled data | 114/1,672 (6.8) | 129/1,683 (7.7) | –0.8 (–2.6, 0.9) | 0.35 |
RE-NOVATE | 53/880 (6.0) | 60/897 (6.7) | –0.7 (–2.9, 1.6) | |
RE-NOVATE II | 61/792 (7.7) | 69/786 (8.8) | –1.1 (–3.8, 1.6) | |
Major VTEb and VTE-related mortalityc | ||||
Pooled data | 46/1,714 (2.7) | 69/1,712 (4.0) | –1.4 (–2.6, –0.2) | 0.03 |
RE-NOVATE | 28/909 (3.1) | 36/917 (3.9) | –0.8 (–2.5, 0.8) | |
RE-NOVATE II | 18/805 (2.2) | 33/795 (4.2) | –1.9 (–3.6, –0.2) | |
Symptomatic events | ||||
Symptomatic VTEd | 17/2,138 (0.8) | 16/2,134 (0.7) | ||
Symptomatic DVT | 6/2,138 (0.3) | 5/2,134 (0.2) | 1.00 | |
Symptomatic PE | 6/2,138 (0.3) | 5/2,134 (0.2) | 1.00 | |
Death | 3/2,138 (0.1) | 1/2,134 (0.0) | 0.62 | |
Total asymptomatic DVT | 100/1,665 (6.0) | 122/1,677 (7.3) | ||
Proximal | 35/1,709 (2.0) | 63/1,706 (3.7) | ||
Distal only | 65/1,666 (3.9) | 59/1,679 (3.5) | ||
Total study period (treatment + follow-up) | ||||
Symptomatic VTE + all-cause mortality | 18/2,048 (0.9) | 19/2,059 (0.9) | 0.09 | |