Table 1.
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 | – |
4F-PCC = four-factor prothrombin complex concentrate, GCS = Glasgow Coma Scale, IQR = interquartile range, SD = standard deviation
aBlood pressure reported was an average of measurements upon arrival and immediately prior to reversal agent administration for both cohorts
bNot included in the propensity score model due to lack of heterogeneity between groups at baseline
cIntracranial hemorrhage types add up to > 100% given a portion of patients had multicompartment bleeds
dThe median (IQR) dose was 2028 units (1728–2393) for patients receiving 25 units/kg and 3443 units (2911–4208) for those receiving 50 units/kg