The incidence and absolute risk difference of the composite primary end point during the first 6 months of follow-up for aspirin (ASA) compared with low-molecular-weight heparin (LMWH) prophylaxis
Event . | ASA (n = 176) . | LMWH (n = 166) . | Absolute difference, % . | 95% CI . | P . |
---|---|---|---|---|---|
Efficacy analysis, n (%) | |||||
Composite primary end point* | 4 (2.27) | 2 (1.20) | 1.07 | −1.69 to 3.83 | .452 |
Any grade 3/4 thromboembolic event, n (%) | 4 (2.27) | 2 (1.20) | 1.07 | −1.69 to 3.83 | .452 |
Deep vein thrombosis | 2 (1.14) | 2 (1.20) | −0.07 | −2.35 to 2.21 | .953 |
Pulmonary embolism | 3 (1.70) | 0 | 1.70 | −0.21 to 3.62 | .091 |
Arterial thrombosis | 0 | 0 | |||
Acute cardiovascular events | 0 | 0 | |||
Sudden deaths | 0 | 0 | |||
Safety analysis, n (%) | |||||
Major bleeding | 0 | 0 | |||
Minor bleeding | 1 (0.60) | −0.60 | −1.78 to 0.57 | .302 | |
Gastrointestinal bleeding | 0 | 1 (0.60) |
Event . | ASA (n = 176) . | LMWH (n = 166) . | Absolute difference, % . | 95% CI . | P . |
---|---|---|---|---|---|
Efficacy analysis, n (%) | |||||
Composite primary end point* | 4 (2.27) | 2 (1.20) | 1.07 | −1.69 to 3.83 | .452 |
Any grade 3/4 thromboembolic event, n (%) | 4 (2.27) | 2 (1.20) | 1.07 | −1.69 to 3.83 | .452 |
Deep vein thrombosis | 2 (1.14) | 2 (1.20) | −0.07 | −2.35 to 2.21 | .953 |
Pulmonary embolism | 3 (1.70) | 0 | 1.70 | −0.21 to 3.62 | .091 |
Arterial thrombosis | 0 | 0 | |||
Acute cardiovascular events | 0 | 0 | |||
Sudden deaths | 0 | 0 | |||
Safety analysis, n (%) | |||||
Major bleeding | 0 | 0 | |||
Minor bleeding | 1 (0.60) | −0.60 | −1.78 to 0.57 | .302 | |
Gastrointestinal bleeding | 0 | 1 (0.60) |
The composite primary end point was the first episode of any objectively confirmed symptomatic deep vein thrombosis, pulmonary embolism, arterial thrombosis, acute cardiovascular event (acute myocardial infarction or stroke), or sudden otherwise unexplained death (presumed to be related to pulmonary embolism, acute myocardial infarction, or stroke).