Encore Presentations
Saturday, November 11, 2023
11:30 AM–01:00 PM
Abstract
Background:
Factor Xa inhibitors reduce the risk of ischemic events but carry an increased risk of major bleeding. Until andexanet alfa was approved in 2018, options for treating such bleeds were limited. Data comparing andexanet alfa versus 4-factor prothrombin complex concentrate (4F-PCC) in routine clinical practice are needed.
Aim:
To compare in-hospital mortality in patients treated with either andexanet alfa or 4F-PCC while hospitalized for rivaroxaban- or apixaban-associated major bleeding.
Methods:
This multicenter, observational study collected patient chart data from 354 US hospitals with andexanet alfa or 4F-PCC (or both) on formulary. Included patients were aged =18 years, treated with andexanet alfa or 4F-PCC during hospitalization for an anticoagulant-related major bleed (ICD-10 code D68.32, indicating bleeding due to extrinsic anticoagulants) between 7/2018 and 9/2022, received apixaban or rivaroxaban prior to hospitalization, and had a documented discharge disposition. In-hospital mortality for andexanet alfa versus 4F-PCC was compared via multivariable logistic regressions overall and by bleed location.
Results:
A total of 4395 patients were identified treated with andexanet alfa (n=2,122) or 4F-PCC (n=2,273). The two main bleed locations were gastrointestinal (58%) and intracranial hemorrhage (30%). Overall, in-hospital mortality occurred in 6.0% of patients treated with andexanet alfa and in 10.6% of the 4F-PCC cohort. Patients treated with andexanet alfa had a 50% lower likelihood of in-hospital mortality compared to 4F-PCC (adjusted OR 0.50 [95% CI 0.38-0.65], p<0.001). In-hospital mortality in patients with ICH was 12.6% with andexanet alfa and 23.3% with 4F-PCC (adjusted OR 0.54 [95% CI 0.39-0.75]). In patients with gastrointestinal bleeds in-hospital mortality was 2.5% with andexanet alfa and 4.3% with 4F-PCC (adjusted OR 0.48 [95% CI 0.28-0.79])..
Conclusion:
Andexanet alfa was associated with a 50% lower likelihood of in-hospital mortality compared with 4F-PCC in patients with rivaroxaban- or apixaban-associated major bleeds. This result was similar in gastrointestinal bleeds and ICH.
Presenting Author
Paul Dobesh PharmD, FAHA, FCCP, BCPS, BCCPUniversity of Nebraska Medical Center
Authors
Bruce Koch PharmD
AstraZeneca
Eva Lesén PhD
AstraZeneca
Hungta Chen PhD
AstraZeneca Pharmaceuticals
Mary J. Christoph PhD, MPH
AstraZeneca
Craig I. Coleman PharmD
University of Connecticut
Mark Danese PhD, MHS
Outcomes Insights
Sherry Danese MBA
Outcomes Insights
Gregory J. Fermann MD
University of Cincinnati
Julie Ulloa PhD
Outcomes Insights