Reversal of Factor Xa Inhibitor-Related Intracranial Hemorrhage: A Multicenter, Retrospective, Observational Study Comparing the Efficacy and Safety of Andexanet and Prothrombin Complex Concentrates.

OBJECTIVE

To determine the effectiveness and safety of andexanet and prothrombin complex concentrates (PCCs) when administered after intracranial hemorrhage (ICrH) associated with direct oral anticoagulants, specifically apixaban or rivaroxaban.

DESIGN

A multicenter, retrospective, observational study of patients with apixaban or rivaroxaban-related ICrH who received andexanet or PCCs between January 1, 2015, and March 31, 2023. A predefined sensitivity analysis excluding patients with an admission Glasgow Coma Scale score of less than 7 was also performed.

SETTING

Forty-two stroke centers in the United States.

PATIENTS: A total of 1133 patients.

INTERVENTIONS: None.

MEASUREMENTS AND MAIN

RESULTS

The primary efficacy outcome was the percentage of patients with excellent or good hemostasis as defined by the modified Sarode criteria. The primary safety outcome was the occurrence of a thrombotic event (TE) during their hospital stay. Of the 1133 patients evaluated, 1096 were included. In the full hemostatic efficacy analysis, patients receiving andexanet (87.8%) had higher odds of achieving excellent or good hemostasis (odds ratio [OR] 1.60; 95% CI, 1.00-2.56; p = 0.048) compared with PCCs (81.8%). Patients treated with andexanet (7.9%) had higher odds of a TE (OR 1.91; 95% CI, 1.13-3.20; p = 0.014) compared to those treated with PCCs (4.2%). No differences in hemostatic or thrombotic outcomes were observed when the sensitivity analysis was applied.

CONCLUSIONS

Despite statistically higher odds of achieving hemostatic efficacy with andexanet, we also observed higher odds of a TE with no difference in discharge outcomes observed between groups. When those with more severe neurologic injuries were excluded, efficacy and safety outcomes were similar between treatments.