Table 2.
Primary Composite Outcome | Control (n = 237) (%) | FEIBA (n = 82) (%) | p Value |
---|---|---|---|
Thrombotic events | 18 (7.6) | 9 (11.0) | 0.343 |
Secondary outcomes | |||
Ischemic CVA | 4 (1.7) | 0 (0.0) | 0.576 |
ICH | 3 (1.3) | 0 (0.0) | 0.572 |
Combination CVA | 1 (0.4) | 0 (0.0) | 1.000 |
Pump thrombus | 0 (0.0 | 0 (0.0) | 1.000 |
Pulmonary embolism | 1 (0.4) | 0 (0.0) | 1.000 |
Deep vein thrombosis | 13 (5.5) | 9 (11.0) | 0.091 |
GI bleeds | 5 (2.1) | 1 (1.2) | 1.000 |
Mortality | 3 (1.3) | 3 (3.7) | 0.179 |
NOTE. Thrombotic events, composite thrombotic outcome of ischemic cerebrovascular accident (iCVA), intracranial hemorrhage (ICH), combination iCVA with hemorrhagic conversion (combination CVA), pump thrombus, pulmonary embolism, and deep venous thrombosis in first 14 days. Categorical variables analyzed by Fischer exact test for n ≤five and chi-squared test for n > five.
Abbreviations: FEIBA, Factor Eight Inhibitor Bypassing Activity; .GI, gastrointestinal.