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. 2024 Nov 7;5(6):e13333.
doi: 10.1002/emp2.13333. eCollection 2024 Dec.

Management of factor Xa inhibitor-related traumatic non-intracranial bleeding events with andexanet alfa or four-factor prothrombin complex concentrate in a US multicenter observational study

Paul P Dobesh  1 , Craig I Coleman  2   3 , Mark Danese  4 , Eva Lesén  5 , Raymond C Chang  6 , Onivefu Odelade  7 , Gregory J Fermann  8
Affiliations

Management of factor Xa inhibitor-related traumatic non-intracranial bleeding events with andexanet alfa or four-factor prothrombin complex concentrate in a US multicenter observational study

Paul P Dobesh et al. J Am Coll Emerg Physicians Open. .

Abstract

Objectives: This study describes clinical characteristics and management strategies for patients with factor Xa (FXa) inhibitor-related traumatic non-intracranial bleeds who were treated with andexanet alfa or four-factor prothrombin complex concentrate (4F-PCC).

Methods: An observational cohort study (ClinicalTrials.gov Identifier: NCT05548777) was conducted using electronic health records from 354 US hospitals. Included patients were hospitalized with rivaroxaban- or apixaban-related bleeding, had received andexanet alfa or 4F-PCC treatment during their hospitalization, and were discharged between May 2018 and September 2022. This analysis was performed in the subgroup of patients with traumatic non-intracranial critical compartment/non-compressible bleeds or other traumatic bleeds.

Results: The study population included 250 patients (andexanet alfa, n = 116; 4F-PCC, n = 134). Critical compartment bleeds were the most common (86.8%), with retroperitoneal bleeds the most common subtype (30.9%). Most patients were admitted via the emergency department (82.0%). The median time from presentation to reversal/replacement treatment was 2.7 (interquartile range, 1.2, 6.6) h. For patients treated with andexanet alfa, 63.8% were administered the low-dose regimen. For 4F-PCC, a median of 2000 total units was administered per patient. Other treatment strategies used included intravenous fluids (26.0%), fresh frozen plasma (16.0%), and packed red blood cells (13.2%). Prior to hospital discharge, oral anticoagulants were restarted in 20.4% of patients. Overall, 25 (10.0%) patients died in hospital.

Conclusion: This analysis provides insights into the clinical characteristics and management strategies, including time to treatment, for patients treated with andexanet alfa or 4F-PCC while hospitalized for FXa inhibitor-related traumatic bleeds.

Keywords: andexanet alfa; blood coagulation factor; factor Xa inhibitors; hemorrhage; injury.

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Conflict of interest statement

Conceptualization: Paul P. Dobesh, Craig I. Coleman, Mark Danese, and Gregory J. Fermann. Data collection and analysis: Mark Danese. Critical review and evaluation of the results and critical review and editing of the paper: Paul P. Dobesh, Craig I. Coleman, Mark Danese, Eva Lesén, Raymond C. Chang, Onivefu Odelade, and Gregory J. Fermann. Study supervision: Paul P. Dobesh, Craig I. Coleman, Eva Lesén, and Gregory J. Fermann.Paul P. Dobesh served as a consultant for the Pfizer/Bristol Myers Squibb Alliance, AstraZeneca, and Janssen Pharmaceuticals. Craig I. Coleman received research funding and/or consulting honoraria from Janssen Pharmaceuticals, Bayer AG, and AstraZeneca. Mark Danese is an employee of Outcomes Insights, which received research funding related to cardiovascular disease from Amgen and Boston Scientific. Eva Lesén, Raymond C. Chang, and Onivefu Odelade are employees of AstraZeneca. Gregory J. Fermann served on a speakers bureau for Janssen Pharmaceuticals and AstraZeneca, served as a consultant for Milestone Pharmaceuticals, and received research funding from Siemens PCORI and the National Institutes of Health.

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