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

Authors

Paul P. Dobesh, University of Nebraska Medical CenterFollow
Gregory J. Fermann, University of Cincinnati
Mary J. Christoph, AstraZeneca
Bruce Koch, AstraZeneca
Eva Lesén, AstraZeneca
Hungta Chen, AstraZeneca
Belinda Lovelace, AstraZeneca
Theresa Dettling, AstraZeneca
Mark Danese, Outcomes Insights
Julie Ulloa, Outcomes Insights
Sherry Danese, Outcomes Insights
Craig I. Coleman, University of Connecticut School of Pharmacy

Document Type

Article

Journal Title

Research and Practice in Thrombosis and Haemostasis

Publication Date

2023

Volume

7

Abstract

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.

DOI Link

10.1016/j.rpth.2023.102192

ISSN

2475-0379

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International License.

Recommended Citation

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.
https://digitalcommons.unmc.edu/cop_pharmpract_articles/8