Research and Practice in Thrombosis and Haemostasis
BACKGROUND: Well-designed studies with sufficient sample size comparing andexanet alfa vs 4-factor prothrombin complex concentrate (4F-PCC) in routine clinical practice to evaluate clinical outcomes are limited.
OBJECTIVES: To compare in-hospital mortality in patients hospitalized with rivaroxaban- or apixaban-related major bleeding who were treated with andexanet alfa or 4F-PCC.
METHODS: An observational cohort study (ClinicalTrials.gov identifier: NCT05548777) was conducted using electronic health records between May 2018 and September 2022 from 354 U.S. hospitals. Inclusion criteria were age ≥18 years, inpatient admission with diagnosis code D68.32 (bleeding due to extrinsic anticoagulation), a record of use of the factor Xa inhibitors rivaroxaban or apixaban, andexanet alfa or 4F-PCC treatment during index hospitalization, and a documented discharge disposition. Multivariable logistic regression on in-hospital mortality with andexanet alfa vs 4F-PCC was performed. The robustness of the results was assessed via a supportive propensity score-weighted logistic regression.
RESULTS: The analysis included 4395 patients (andexanet alfa,
CONCLUSION: In this large observational study, treatment with andexanet alfa in patients hospitalized with rivaroxaban- or apixaban-related major bleeds was associated with 50% lower odds of in-hospital mortality than 4F-PCC. The magnitude of the risk reduction was similar in ICH and GI bleeds.
Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International License.
Dobesh, Paul P.; Fermann, Gregory J.; Christoph, Mary J.; Koch, Bruce; Lesén, Eva; Chen, Hungta; Lovelace, Belinda; Dettling, Theresa; Danese, Mark; Ulloa, Julie; Danese, Sherry; and Coleman, Craig I., "Lower Mortality with Andexanet Alfa vs 4-Factor Prothrombin Complex Concentrate for Factor Xa Inhibitor-Related Major Bleeding in a U.S. Hospital-Based Observational Study" (2023). Journal Articles: Pharmacy Practice. 8.