Calvin Ice, PharmD, BCPS, BCCCP
Pharmacist
Spectrum Health Butterworth Hospital, United States
Disclosure information not submitted.
Matthew Gurka, BCCCP, PharmD
Pharmacist
Spectrum Health Butterworth Hospital, United States
Disclosure information not submitted.
Jessica Parker, MS, GStat
Biostatistician Lead
Spectrum Health, United States
Disclosure information not submitted.
Title: FEIBA and Andexanet Alfa for the Reversal of Apixaban and Rivaroxaban in Uncontrolled Hemorrhage
Background: The increased use of apixaban and rivaroxaban for anticoagulation has led to a rise in factor Xa inhibitor-associated bleeding events. Andexanet alfa was granted accelerated approval by the Food and Drug Administration (FDA) and remains the only FDA-approved reversal agent for apixaban and rivaroxaban. FEIBA, an activated prothrombin complex concentrate, is commonly used off-label for reversal of factor Xa inhibitors in life-threating bleeding events; however, literature is limited. The purpose of the present study was to compare FEIBA versus andexanet alfa with regards to hemostasis and thrombotic events for apixaban or rivaroxaban associated life-threatening bleeds.
Methods: This retrospective study evaluated patients who received reversal. Data was collected from November 4, 2017 to August 31, 2019 for patients who received FEIBA and September 30, 2019 to August 31, 2020 for patients who received andexanet alfa. The primary study outcome was the percentage of patients who achieved excellent or good hemostasis within twelve hours of reversal. Safety outcomes assessed included: percentage of patients who experienced an inpatient adverse event (thrombotic event or hemorrhagic complication) and mortality during hospital admission.
Results: 155 patients received either FEIBA or andexanet alfa for apixaban or rivaroxaban reversal and screened for inclusion. A propensity matched analysis occurred matching baseline characteristics: 31 received FEIBA and 16 received andexanet alfa meeting inclusion criteria. For the primary outcome, 24 out of 31 patients (77.4%) in the FEIBA group and 11 out of 16 patients (68.8%) in the andexanet alfa group achieved excellent or good hemostasis (p=0.725). No statistically significant safety outcomes were observed for in-hospital mortality, thrombotic complication, or hemorrhagic complication.
Conclusion: The overall rates of effective hemostasis, mortality, thrombosis, and hemorrhagic complication were similar in the FEIBA and andexanet alfa groups after propensity matching. Due to our small population size, larger prospective studies are needed to evaluate the use of FEIBA versus andexanet alfa to determine effectiveness between agents.