Abstract
AbstractBackgroundSince FDA approvals, apixaban and rivaroxaban use has steadily increased. Currently, FEIBA® has been used off-label for factor Xa inhibitor reversal yet there are limited studies to support this practice. Therefore, additional safety and effectiveness data is needed for apixaban and rivaroxaban reversal in patients with an associated bleeding event.MethodsThe following retrospective study evaluated patients who received at least one dose of FIEBA® for the reversal of apixaban or rivaroxaban. One hundred forty-seven patients with an acute bleed were evaluated. The primary study outcome sought to determine the percentage of patients who achieved excellent or good hemostatic effectiveness within 12 hours of FEIBA® administration. The primary safety outcomes assessed the percent of patients who experienced an inpatient adverse event defined by thrombosis or mortality during hospital admission post-FEIBA® administration.ResultsAmong the 147 patients evaluated, 58 experienced an intracranial hemorrhage (ICH) and 89 experienced a non-ICH bleeding event. One hundred fifteen patients (78%) achieved excellent or good hemostasis. Three patients (2%) experienced a thrombotic complication while another 3 patients (2%) had a hemorrhagic complication. A total of 15 patients (10%) experienced in-hospital mortality following FEIBA® administration.ConclusionThis retrospective study supports the safety and effectiveness of FEIBA® for the management of acute bleeding events secondary to apixaban and rivaroxaban. FEIBA® achieved excellent or good (collectively defined as effective) hemostasis similarly for ICH and non-ICH bleeding events in patients receiving apixaban or rivaroxaban. Furthermore, the thromboembolism outcomes associated with FEIBA® were minimal. The effectiveness and safety outcomes support FEIBA® as a plausible apixaban and rivaroxaban reversal agent, notably among patients experiencing ICH.
Publisher
Cold Spring Harbor Laboratory