Real-world clinical decision of andexanet alfa administration for intracranial hemorrhage during anticoagulant therapy using factor Xa inhibitor

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Introduction: Andexanet alfa shows excellent hemostatic efficacy in treating intracranial hemorrhage (ICH) during Xa inhibitor therapy. However, its optimal use remains uncertain. Aim of the study: This study aims to evaluate our clinical experience in managing Xa inhibitor-related ICH to clarify its appropriate application. Material and methods: This study was conducted as an observational, non-interventional study. We observed 63 cases of ICH in patients receiving anticoagulation therapy with apixaban, rivaroxaban, or edoxaban. After excluding 14 patients due to fatal outcomes or complete hemostasis, 49 patients were eligible for andexanet alfa administration. Results: The mean age and hematoma volume was 78 years and the 35ml, respectively. Based on patient characteristics and severity, andexanet alfa was administered to 23 patients, while 26 patients received usual care. Hemorrhage enlargement was absent in 22 cases (92.8%) in the andexanet group and in 22 cases (84.6%) in the usual care group. Hemorrhage expansion occurred in three cases from the usual care group, one patient undergoing emergency surgery and another died from uncontrollable intraoperative bleeding. Two patients (8.7%) in the andexanet group experienced thromboembolic events as adverse reactions. At 3 months, the modified Rankin Scale (mRS) was 3 or lower in 39% of the andexanet group and 50% of the standard care group. Conclusions: Although patient selection bias make it difficult to draw definitive conclusions, we recommend considering andexanet alfa administration for cases within several hours of the last Xa inhibitor dose to prevent neurological deterioration. Emergency surgical cases should also be eligible for andexanet alfa to ensure intraoperative safety. Further research is required to determine clinically appropriate indications for its use.

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