Archive | 2021
Real-Life Applications and Challenges of Andexanet Alfa for Life-Threatening Bleeding and Reversal Prior to Surgery
Abstract
Andexanet alfa is a targeted reversal agent for apixaban and rivaroxaban for life-threatening or uncontrolled bleeding. There are few multicenter, real world studies that also include patients with off-label use who require emergent surgery. The objective was to describe hemostatic efficacy, thrombotic events, clinical applications, pharmaceutical challenges, and mortality associated with reversing apixaban and rivaroxaban with andexanet alfa in clinical practice. Retrospective descriptive observational cohort study of andexanet alfa use at 2 academic medical centers in the United States from July 1, 2018 to September 30, 2019. Ninety patients received 91 doses of andexanet alfa including 6 for reversal prior to surgery. Effective hemostasis was achieved in 72.9% of bleeding episodes and all patients that received andexanet alfa preoperatively were deemed to have effective hemostasis. Thrombotic events occurred in 7 of 90 patients (7.7%) and 2 of these events occurred the day after administration. Incorrect high-dose andexanet alfa was given 11 times with an estimated excess expenditure of $272,250. Thirty-two of 90 (35.5%) patients died, and most deaths occurred during the initial hospitalization. Our real-world experience with andexanet alfa in bleeding patients is similar to the non-comparative trial that led to Food and Drug Administration approval, and our findings show good hemostatic efficacy in a small number of patients requiring emergent surgery. We highlight the importance of appropriate dose based on time of ingestion and factor Xa inhibitor dose. Our 2 institutions spent over a quarter of a million dollars on excess andexanet alfa in a year and a half.