Clinical Course of Intracranial Bleeding in Patients Anticoagulated With Factor Xa inhibitors Without the Use of Specific Reversal Agents

Abstract

Abstract INTRODUCTION Factor Xa inhibitors (FXI) are widely used anticoagulants but may cause or worsen acute major bleeding. Andexanet alfa, a novel anticoagulation reversal agent for FXI, was recently approved. Traumatic intracranial hemorrhage (tICH) presents a prime target for this drug, however questions remain regarding its effect on clinical outcomes compared to the natural history of tICH in the setting of FXI. This study aimed to evaluate the hematoma progression and clinical outcomes of patients on FXI who were not administered Andexanet reversal after tICH. METHODS An institutional traumatic brain injury (TBI) registry was queried between 2016 and 2019. Patients with recorded use of apixaban or rivaroxaban <18 h before injury were included. The primary study outcome was good hemostasis on repeated head computed tomography (CT), assessed according to the criteria of the ANNEXA-4 trial for Andexanet treatment. The secondary outcome was neurological worsening or surgical intervention during the hospitalization. RESULTS We identified 24 patients meeting the study inclusion criteria. Their mean (SD) age was 76.3 ± 13 yr and 10 (42%) were female. On admission CT, 15 patients had SDH, 6 had traumatic IPH, and 3 had SAH. All patients had their FXI therapy discontinued immediately after injury. Anticoagulation reversal was attempted in 16 patients, most commonly using prothrombin complex concentrate (PCC). Out of the 24 patients, 19 (79%) were adjudicated as having excellent or good hemostasis. A total of 23 (96%) patients remained neurologically stable throughout admission. CONCLUSION Our results indicate that in patients on FXI with complicated mild TBI it can be reasonably safe not to administer specific anticoagulation reversal. Hemostatic and clinical outcomes in our cohort were largely similar to those reported after Andexanet administration. Further research is necessary to determine if administration of Andexanet improves clinical outcomes.