ANNEXA-4: Andexanet Reverses Factor Xa Inhibitors Amid Thrombotic Risk
This single-arm cohort defines the hemostatic and safety profile of andexanet alfa in factor Xa inhibitor-associated major bleeding, the dataset that underpinned its accelerated FDA approval.
andexanet alfaapixabanrivaroxabanedoxabanenoxaparinfactor Xa inhibitorsreversal agentsmajor bleedingintracranial hemorrhageanticoagulationcohort studyANNEXA-4Anticoagulation / Hematology
Background Information
Andexanet alfa reduces factor Xa activity by 92% in bleeding emergencies.
Major bleeding is a critical concern for patients using factor Xa inhibitors, and andexanet alfa offers a potential reversal option. Andexanet alfa reduced anti-factor Xa activity by 92% in patients on apixaban and rivaroxaban, achieving good or excellent hemostatic efficacy in 82% of cases. While andexanet effectively reduced factor Xa inhibitor activity and improved hemostasis, the associated thrombotic events and mortality highlight the need for careful patient monitoring. Andexanet alfa rapidly reverses factor Xa inhibitors, improving bleeding control in most cases but requires vigilant monitoring for thrombotic risks.
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Authors:Connolly SJ, Crowther M, Eikelboom JW, Gibson CM, Curnutte JT, Lawrence JH, Yue P, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Demchuk AM, Pallin DJ, Concha M, Goodman S, Leeds J, Souza S, Siegal DM, Zotova E, Meeks B, Ahmad S, Nakamya J, Milling TJ Jr, ANNEXA-4 Investigators
Citation:Connolly SJ, Crowther M, Eikelboom JW, et al. Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors. The New England journal of medicine. 2019;380(14):1326-1335. doi:10.1056/NEJMoa1814051