Table 4 PROTECT results excluding patients co-enrolled in another randomized trial
N (%) | Dalteparin (N= 1,873) All patients | UFH (N= 1,873) All patients | Hazard ratio (95%CI) | Dalteparin (N= 1,664) Not co-enrolled in RCT | UFH (N= 1,633) Not co-enrolled in RCT | Hazard ratio (95%CI) |
|---|---|---|---|---|---|---|
Primary outcome: proximal leg deep vein thrombosis | 94 (5.1) | 108 (5.9) | 0.91 (0.68, 1.23) | 83 (5.0) | 93 (5.7) | 0.87 (0.63, 1.21) |
Any pulmonary embolism | 22 (1.2) | 42 (2.3) | 0.48 (0.27, 0.84) | 19 (1.1) | 35 (2.1) | 0.48 (0.26, 0.89) |
Any venous thromboembolism | 150 (8.2) | 184 (10.0) | 0.87 (0.69, 1.10) | 133 (8.0) | 161 (9.9) | 0.83 (0.64, 1.07) |
Major bleeding | 100 (5.5) | 105 (5.7) | 0.98 (0.73, 1.31) | 88 (5.3) | 93 (5.7) | 0.94 (0.69, 1.28) |
Heparin-induced thrombocytopenia | 5 (0.3) | 12 (0.7) | 0.47 (0.16, 1.37) | 5 (0.3) | 10 (0.6) | 0.56 (0.18, 1.67) |
Hospital mortality | 395 (21.7) | 444 (24.3) | 0.91 (0.79, 1.05) | 372 (22.4) | 391 (23.9) | 0.95 (0.82, 1.10) |