Patient characteristics, treatment patterns, and clinical outcomes in patients hospitalized with factor Xa inhibitor-associated major bleeds: A report from the REVERXaL study

Background Real-world data on the characteristics, interventions, and associated outcomes of patients hospitalized with factor Xa (FXa) inhibitor-associated major bleeds are limited.ObjectiveThe REVERXaL study was designed to gain an understanding of patient characteristics, treatment approaches, and associated outcomes for FXa inhibitor-associated bleeds in real-world clinical practice.MethodsREVERXaL was designed to include historical and prospective cohorts of patients with FXa inhibitor-associated major bleeds from the United States, Germany, the United Kingdom, and Japan. Results for the historical cohort, which included information from electronic case report forms from admission to discharge for patients hospitalized for FXa inhibitor-related bleeds, are presented here. Evaluated outcomes included patient characteristics, physician-reported hemostatic effectiveness, thromboembolic event occurrence, and mortality.ResultsThe historical cohort included 2025 patients hospitalized with FXa inhibitor-associated major bleeds (intracranial hemorrhage [ICH], n = 1353; gastrointestinal bleeds, n = 357; other, n = 315) from 74 clinical sites (October 2021–November 2024). The mean (SD) age was 78.5 (10.4) years, and patients had a high comorbidity burden. The Glasgow Coma Scale rating was moderate to severe for 30.1% (407/1353) of patients with ICH. The majority of patients (70.4% [1425/2025]) received reversal/replacement therapy, administered a median (interquartile range) of 134.0 (232.0) min after admission. Among patients receiving reversal/replacement therapy, 71.1% (1013/1425) achieved physician-reported hemostasis. Thromboembolic events were reported in 6.1% (124/2025) of patients. The overall in-hospital mortality rate was 21.9% (443/2025).ConclusionsGiven the high mortality rate, these findings suggest a need for improved treatment of FXa inhibitor-associated major bleeds.RegistrationClinicalTrials.gov identifier: NCT06147830.