Variable | Andexanet alfa n = 107 | 4F-PCC n = 95 | Absolute standardized difference |
---|---|---|---|
Demographics | |||
Age (years), mean ± SD | 79 ± 8 | 77 ± 11 | 0.21 |
Male, % | 49.5 | 52.6 | 0.07 |
Body mass index (kg/m2), mean ± SD | 27 ± 7 | 28 ± 6 | 0.14 |
Creatinine clearance (mL/min), mean ± SD | 64 ± 28 | 73 ± 44 | 0.24 |
Systolic blood pressure > 160 mm Hg, %a | 12.1 | 20.0 | 0.33 |
GCS scoreb | 14 ± 1 | 14 ± 2 | 0.00 |
Anticoagulant indication and medical history, % | |||
Anticoagulant indication, atrial fibrillation | 87.9 | 82.1 | 0.25 |
Medical history of heart failure | 18.7 | 23.2 | 0.15 |
Medical history of diabetes | 28.0 | 27.4 | 0.02 |
Medical history of myocardial infarction | 12.1 | 8.4 | 0.22 |
Medical history of stroke | 21.5 | 24.2 | 0.08 |
Concomitant use of an antiplatelet | 33.6 | 24.2 | 0.25 |
Intracranial hemorrhage characteristics | |||
Initial imaging to reversal start (hours), mean ± SD | 2.6 ± 1.8 | 2.1 ± 1.9 | 0.30 |
End of reversal to repeat imaging (hours), mean ± SD | 12.4 ± 1.1 | 8.1 ± 5.1 | 1.21 |
Traumatic onset, % | 53.3 | 64.2 | 0.25 |
Infratentorial location, % | 16.8 | 12.6 | 0.19 |
Size of bleed ≥ 10 mL/mm, % | 33.6 | 14.7 | 0.59 |
Single compartment bleed, % | 77.6 | 85.3 | 0.28 |
Intracerebral and/or intraventricular bleed, %c | 59.8 | 48.4 | 0.25 |
Subdural bleed, %c | 32.7 | 40.0 | 0.17 |
Subarachnoid bleed, %c | 31.8 | 27.4 | 0.12 |
Reversal agent dosing, %b | |||
Andexanet alfa | |||
400 mg bolus + 440 mg infusion | 96.3 | – | – |
800 mg bolus + 860 mg infusion | 3.7 | – | – |
4F-PCC | |||
25 units/kg infusiond | – | 74.3 | – |
50 units/kg infusiond | – | 25.3 | – |