Background: The clinical use of factor VIII inhibitor bypassing activity (FEIBA) for factor Xa (FXa) inhibitor reversal is derived from small studies with notable variation in patient eligibility for use, dosage regimens, concurrent supportive care, and outcome measures. Consequently, additional effectiveness and safety data are warranted to expand the literature evaluating FEIBA for FXa inhibitor reversal. Objective: This study sought to determine the incidence of observed effective hemostasis within 24 hours of post-FEIBA® administration as well as in-hospital and 30-day post-discharge incidences of thromboembolic event (TEE) and mortality between apixaban and rivaroxaban in the intracranial hemorrhage (ICH) and non-ICH populations. Methods: This case series evaluated patients between January 1, 2014 through July 1, 2019 who received at least one FEIBA® dose for apixaban or rivaroxaban reversal secondary to acute ICH or non-ICH. Patient demographics, FEIBA® dosages, adjunct treatments, effectiveness, and safety outcomes were retrospectively collected from electronic medical record review. Modified hemostasis outcomes, adapted from criteria previously published by Sarode et al., TEE, and mortality between apixaban and rivaroxaban in the ICH and non-ICH populations were evaluated. Results: Among the 104 patients evaluated, 62 received apixaban and 42 rivaroxaban. Thirty apixaban and 25 rivaroxaban users experienced ICH, whereas 32 apixaban and 17 rivaroxaban users experienced non-ICH. Among the combined ICH and non-ICH populations, effective hemostasis occurred in 89%, TEE in 8%, and mortality in 13%. No statistically significant differences were observed within ICH and non-ICH populations receiving apixaban or rivaroxaban regarding effective hemostasis, TEE, or mortality. Conclusion and Relevance: The combined ICH and non-ICH overall rates of effective hemostasis, TEE, and mortality were comparable to preexisting studies of FEIBA for factor Xa inhibitor reversal. The limitations inherent to the study design warrant a randomized controlled trial with an active comparator to confirm these observations.
Background Since 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. Methods The 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. Results Among 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. Conclusion This 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.
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