Andexanet alfa effectiveness and safety versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage while on apixaban or rivaroxaban: A single-center, retrospective, matched cohort analysis

• Published in: The American journal of emergency medicine Vol. 55; pp. 16 - 19
• Main Authors: Parsels, Katie A., Seabury, Robert W., Zyck, Stephanie, Miller, Christopher D., Krishnamurthy, Satish, Darko, William, Probst, Luke A., Latorre, Julius Gene, Cwikla, Gregory M., Feldman, Elizabeth A.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2022; Elsevier Limited
• Subjects: Anticoagulants; Anticoagulants - adverse effects; Blood Coagulation Factors - therapeutic use; Brain hemorrhage; Cohort analysis; Cohort Studies; Demographics; Direct-acting oral anticoagulants; Emergency medical care; Factor Xa; Factor Xa Inhibitors - adverse effects; Hemorrhage; Hemostasis; Humans; Intracranial hemorrhage; Intracranial Hemorrhages - chemically induced; Intracranial Hemorrhages - drug therapy; Length of stay; Magnetic resonance imaging; Neurosurgery; Patients; Prothrombin; Prothrombin complex concentrate; Pyrazoles; Pyridones; Recombinant Proteins; Retrospective Studies; Rivaroxaban - adverse effects; Safety; Thrombosis; Intracranial hemorrhage; Direct-acting oral anticoagulants; Brain hemorrhage; Hemostasis; Thrombosis; Prothrombin complex concentrate
• ISSN: 0735-6757; 1532-8171
• DOI: 10.1016/j.ajem.2022.02.036

There is limited information directly comparing andexanet alfa (AA) versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage (ICH) on apixaban or rivaroxaban. The objective of this study was to compare the effectiveness and safety of AA versus 4F-PCC in ICH on apixaban or rivaroxaban. This retrospective, matched, cohort analysis was conducted at a single healthcare system. Patients were matched based on baseline ICH volume. The primary outcome was good or excellent ICH hemostasis, which was defined as a 35% or less increase in ICH volume within 24 h following AA or 4F-PCC administration. The secondary outcome was thrombotic events within 14 days following AA or 4F-PCC administration. In total, 26 AA and 26 4F-PCC patients were included in this matched cohort analysis. Both groups had comparable rates of good or excellent ICH hemostasis (AA: 92.3% vs. 4F-PCC: 88.5%, p = 1.000). Thrombotic events within 14-days were not significantly different (AA: 26.9% vs. 4F-PCC: 11.5%, p = 0.159). This study found no significant differences in good or excellent ICH hemostasis within 24-h or new thrombotic events within 14-days in a cohort given AA or 4F-PCC for ICH while on apixaban or rivaroxaban. However, this single-center analysis is underpowered due to sample size constraints, therefore further high-quality research comparing AA safety and effectiveness versus 4F-PCC is needed.