Table 3. Secondary Outcomes at 28 Days and Individual Components.
Outcome | No. (%) | Absolute difference, % (95% CI) |
Odds ratio (95% CI)a | ||
---|---|---|---|---|---|
Therapeutic dose of heparin plus P2Y12 inhibitor (n = 293) |
Therapeutic dose of heparin only (usual care) (n = 269) |
Unadjusted | Adjustedb | ||
Secondary outcomes | |||||
Major thrombotic eventc or in-hospital death | 18 (6.1) | 12 (4.5) | 1.6 (−2.1 to 5.3) | 1.40 (0.66 to 2.97) | 1.42 (0.64 to 3.13) |
Any thrombotic eventd or in-hospital death | 20 (6.8) | 12 (4.5) | 2.3 (−1.5 to 6.1) | 1.57 (0.75 to 3.28) | 1.60 (0.73 to 3.50) |
Major bleeding evente or in-hospital death | 18 (6.1) | 10 (3.7) | 2.4 (−1.1 to 5.9) | 1.69 (0.77 to 3.75) | 1.80 (0.79 to 4.10) |
Components of the secondary outcomes | |||||
In-hospital death | 13 (4.4) | 8 (3.0) | |||
Major thrombotic eventc | 7 (2.4) | 5 (1.9) | |||
Any thrombotic eventd | 9 (3.1) | 5 (1.9) | |||
Major bleeding evente | 6 (2.0) | 2 (0.7) | 1.3 (−0.6 to 3.2) | 2.65 (0.53 to 13.4) | 3.31 (0.64 to 17.2) |
An odds ratio less than 1 corresponded with a treatment benefit (eg, treatment was associated with fewer adverse events).
Adjusted for age, sex, enrollment epoch, cardiovascular disease (composite of hypertension, heart failure, coronary artery disease, peripheral artery disease, cerebrovascular disease), and baseline respiratory support. Study country and hospital site were treated as nested random effects.
Includes pulmonary embolism, myocardial infarction, ischemic stroke, and other arterial or venous thromboembolism events.
Includes major thrombotic events and deep vein thrombosis.
Defined by the International Society on Thrombosis and Hemostasis as fatal bleeding, symptomatic bleeding in a critical area or organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome), bleeding causing a decrease in hemoglobin level of 2 g/dL or greater, or bleeding leading to transfusion of 2 units or greater of whole blood or red cells.