Abstract

Introduction: While andexanet alfa (AA) is approved for reversal of bleeding associated with factor Xa inhibitors, rates of mortality, efficacy, and thrombotic events from retrospective studies evaluating AA and four factor prothrombin complex concentrate (PCC) are similar, with significant differences noted in cost between agents. However, many of these studies have low power and competing findings. This study sought to characterize all-cause mortality, efficacy, and morbidity of patients administered AA and PCC within a single hospital network. Methods: This was a retrospective cohort study of adult patients administered AA or PCC between October 2018 and June 2020 for reversal of bleeding associated with factor Xa inhibitor usage. Patients were excluded if reversal was attempted prior to an emergent operation. The primary endpoint was hospital mortality, with concurrent evaluation of 60-day all-cause mortality, thrombotic event rates, and discharge disposition. Results: 142 patients presented with bleeding requiring anticoagulation reversal within the study period. 94 patients received PCC and 48 patients received AA. Patient groups were similar with regards to all demographic characteristics except for gender, and had similar Glasgow Coma Scale (GCS) and Charlson Comorbidity Index (CCI) scores. Traumatic injury causing bleeding was noted in 44.7% vs 41.7% of PCC vs AA patients (p=0.732). Central nervous system (CNS) bleeds were noted in 43.6% vs 43.8% of PCC and AA patients, with similar rates of CNS, gastrointestinal (GI), and other locations of bleeding between groups. Efficacy within 48 hours was 75.9% vs 82.4% for PCC and AA in patients with CNS bleeding. In-hospital mortality was higher for patients receiving AA (14.9% vs 27.1%, p=0.006), with similar 60-day mortality, hospital length of stay (LOS), rates of thrombotic events, and discharge disposition. Average cost of AA across study patients was $36,094, while the average cost of PCC was $5,596 (p< 0.001). Conclusions: AA is associated with higher mortality compared to PCC, although with similar rates of thromboembolic complications and efficacy. The mortality difference requires further investigation for confirmation. The cost of AA was higher in comparison to PCC.

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