Andexanet Alfa Versus 4F-PCC for Reversal of Apixaban and Rivaroxaban in Trauma Patients

Sunday, March 22, 2026

11:00 AM - 12:00 PM Central Time

Location: Connections Central - RST 09

Nicole Wendel, PharmD (she/her/hers)

University of Cincinnati / UC Health, Kentucky

Disclosure(s): No relevant financial relationship(s) to disclose.
LP

Lesley Pahs, BCCCP, BCEMP, PharmD

Clinical Pharmacy Specialist, Critical Care and Emergency Medicine
University of Cincinnati Medical Center

Disclosure information not submitted.
NH

Nicole Harger-Dykes, PharmD, BCCCP

Manager, Residency Programs and Professional Development
University of Cincinnati Medical Center

Disclosure information not submitted.
MF

Madeline Foertsch, PharmD, BCCCP, BCPS

Clinical Pharmacy Specialist, Neuro-Critical Care
University of Cincinnati Medical Center

Disclosure information not submitted.
AM

Alyssa McQueen, PharmD, BCPS

Clinical Pharmacy Specialist, Emergency Medicine
University of Cincinnati Medical Center

Disclosure information not submitted.
CP

Carolyn Philpott, BCCCP, PharmD

Clinical Pharmacy Specialist; Surgery, Trauma, and Orthopedics
University of Cincinnati Medical Center

Disclosure information not submitted.
TR

Tim Rice, PharmD, BCCCP

Clinical Pharmacy Specialist, Critical Care
University of Cincinnati Medical Center

Disclosure information not submitted.
PB

Paige Garber Bradshaw, BCCCP, PharmD

Clinical Pharmacy Specialist, Critical Care
University of Cincinnati Medical Center

Disclosure information not submitted.

Introduction: Oral factor Xa inhibitors (FXaIs), such as apixaban and rivaroxaban, are widely prescribed due to their predictable pharmacokinetics and lack of required monitoring. Trauma patients on FXaIs may need urgent reversal for life-threatening bleeding or surgical intervention. Andexanet alfa (AA) is FDA approved for targeted reversal of apixaban and rivaroxaban while 4-factor prothrombin complex concentrate (4F-PCC) has historically been used off-label for treatment. This study compared hemostatic efficacy (HE) and safety of 4F-PCC versus AA for FXaI bleeding in trauma patients.

Methods: This single-center, retrospective cohort study included adult trauma patients who received AA or 4F-PCC to reverse apixaban or rivaroxaban at the University of Cincinnati Medical Center between January 2014 and July 2024. The primary outcome was HE within 24 hours of reversal graded as excellent, good, or poor and stratified by bleed location. For intracranial bleeding, HE was assessed based on stability or progression of bleed size on repeat computed tomography imaging. For extracranial bleeding, HE was assessed by a percentage reduction in hemoglobin and transfusion requirements. Secondary outcomes included 30-day thromboembolic events and mortality.

Results: 104 patients (4F-PCC n=59; AA n=45) were included. Most were male (n=73 [70.19%]) with a median age of 75 years (IQR 67-83) and were prescribed apixaban (n=73 [70.19%]) for atrial fibrillation (n=78 [75%]). For all patients, rates of excellent or good HE were not significantly different between cohorts (45.8% 4F-PCC vs 33.3% AA; p=0.201). Among patients with intracranial bleeds, those who received 4F-PCC were more likely to achieve excellent HE than those with AA (53.6% 4F-PCC vs 27.3% AA; p=0.036). No significant differences in HE were seen for extracranial bleeding (38.7% 4F-PCC vs 50.0% AA; p=0.501). Thromboembolic events (15.6% 4F-PCC vs 18.6% AA; p=0.680) and mortality (15.3% 4F-PCC vs 22.2% AA; p=0.362) at 30-days were similar between groups.

Conclusions: In trauma patients requiring FXaI reversal, 4F-PCC was associated with higher rates of excellent HE in patients with intracranial bleeds. There was no significant difference in extracranial bleeds or overall safety outcomes. Further research is needed to guide optimal FXaI reversal in trauma patients.