Andexanet alfa was associated with a higher rate of significant hemorrhage growth than 4F-PCC (42% vs. 23%, p=0.029) for FXa inhibitor reversal in intracranial hemorrhage.
Does andexanet alfa improve bleeding control compared to 4F-PCC in patients with intracranial hemorrhage on FXa inhibitors?
In real-world practice, 4F-PCC may be a clinically viable alternative to andexanet alfa for reversing FXa inhibitors in intracranial hemorrhage, demonstrating a lower risk of significant hemorrhage growth.
Absolute Event Rate: 0% vs 0%
Introduction: Use of direct oral anticoagulants for atrial fibrillation and venous thromboembolism can cause intracranial bleeding. While guidelines recommend andexanet alfa for reversing factor Xa inhibitors, its high cost and thrombotic risk have led to off-label use of 4F-PCC, despite limited comparative data. This quality improvement study evaluates the effectiveness of andexanet alfa vs. 4F-PCC for bleeding control in clinical practice. Methods: We conducted a retrospective review (Oct 2020–Oct 2024) of patients who: 1) had a head CT showing intracranial hemorrhage, 2) were on a FXa inhibitor, and 3) received 4F-PCC or andexanet alfa. Demographics, clinical severity (NIH Stroke Scale NIHSS, Glasgow Coma Scale GCS), hemorrhage features, treatment timing, and discharge outcomes were compared. Hemorrhage volumes were measured with Synapse imaging software. Primary outcomes were absolute and percent hemorrhage volume change, significant hemorrhage growth (>6 mL or >33%), and neurological deterioration (≥2-point GCS decrease or ≥4-point NIHSS increase). Results: Of 134 eligible patients, 43 received andexanet alfa and 91 received 4F-PCC. Traumatic bleeds accounted for 64% of cases. Common diagnoses included traumatic subdural hemorrhage (n=31), spontaneous intracerebral hemorrhage (n=30), and traumatic multicompartmental hemorrhage (n=28). Mean age was 78 years, baseline GCS was 13, and mean baseline hemorrhage volume was 43 mL (range: 0.1–284 mL). Age, gender, race, and door-to-needle times were similar between groups. Andexanet alfa patients had higher NIHSS (20 vs. 13, p=0.004) and lower GCS (10 vs. 11, p=0.019) on admission. Mean absolute and percent volume changes were similar; however, more patients on andexanet alfa had significant hemorrhage growth (42% vs. 23%, p=0.029). Neurological deterioration rates were comparable. Ischemic or thromboembolic complications were similarly low for andexanet alfa (2%) and 4F-PCC (4%). Conclusions: In this real-world analysis, andexanet alfa was linked to a higher risk of significant intracranial hemorrhage growth than 4F-PCC, despite similar rates of neurological deterioration, thromboembolic events, functional disability, and mortality. 4F-PCC may serve as a clinically viable alternative for reversing FXa inhibitor anticoagulation in intracranial hemorrhage.
Rajpal et al. (Sun,) reported a other. Andexanet alfa was associated with a higher rate of significant hemorrhage growth than 4F-PCC (42% vs. 23%, p=0.029) for FXa inhibitor reversal in intracranial hemorrhage.