Critical care medicine · 2025
Reversal of Factor Xa Inhibitor-Related Intracranial Hemorrhage: A Multicenter, Retrospective, Observational Study Comparing the Efficacy and Safety of Andexanet and Prothrombin Complex Concentrates.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Panos Nicholas G, Jones G Morgan, Cook Aaron M, Peksa Gary D, John Sayona, DeMott Joshua M, Tobias Philip, Da Silva Ivan, Neurocritical Care Society Pharmacy Study Group
Аннотация
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.
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.