4-factor prothrombin complex concentrate is not inferior to andexanet alfa for the reversal or oral factor Xa inhibitors: An Eastern Association for the Surgery of Trauma multicenter study

Jordan M. Estroff, Center for Trauma and Critical Care, Department of Surgery, George Washington University, Washington, DC.
Joseph Devlin, Center for Trauma and Critical Care, Department of Surgery, George Washington University, Washington, DC.
Lara Hoteit, Trauma and Transfusion Medicine Research Center, University of Pittsburgh Medical Center, Pittsburgh, PA.
Adnan Hassoune, Trauma and Transfusion Medicine Research Center, University of Pittsburgh Medical Center, Pittsburgh, PA.
Matthew D. Neal, Trauma and Transfusion Medicine Research Center, University of Pittsburgh Medical Center, Pittsburgh, PA.
Joshua B. Brown, Trauma and Transfusion Medicine Research Center, University of Pittsburgh Medical Center, Pittsburgh, PA.
Liling Lu, Trauma and Transfusion Medicine Research Center, University of Pittsburgh Medical Center, Pittsburgh, PA.
Shannon Kotch, Department of Surgery, Penn State Health Milton S. Hershey Medical Center.
Joshua P. Hazelton, Department of Surgery, Penn State Health Milton S. Hershey Medical Center.
Ashton B. Christian, Department of Surgery, University of California, Irvine, Orange, CA.
Eric O. Yeates, Department of Surgery, University of California, Irvine, Orange, CA.
Jeffry Nahmias, Department of Surgery, University of California, Irvine, Orange, CA.
Lewis E. Jacobson, Ascension St. Vincent, Indianapolis, IN.
Jamie Williams, Ascension St. Vincent, Indianapolis, IN.
Kevin M. Schuster, Department of Surgery, Yale School of Medicine, New Haven, CT.
Rick O'Connor, Yale University/Yale New Haven Hospital, New Haven, CT.
Gregory R. Semon, Department of Surgery, Wright State University Boonshoft School of Medicine, Dayton, OH.
Angela D. Straughn, Miami Valley Hospital, Dayton, OH.
Daniel Cullinane, Maine Medical Center, Portland, ME.
Tanya Egodage, Cooper University, Camden, NJ Grant Medical Center, Columbus, OH.
Michelle Kincaid, OhioHealth Grant Medical Center, Columbus, OH.
Allison Rollins, OhioHealth Grant Medical Center, Columbus, OH.
Richard Amdur, Center for Trauma and Critical Care, Department of Surgery, George Washington University, Washington, DC.
Babak Sarani, Center for Trauma and Critical Care, Department of Surgery, George Washington University, Washington, DC.

Document Type

Article

Publication Date

4-30-2024

Institution/Department

Critical Care Medicine

Journal Title

The journal of trauma and acute care surgery

Abstract

BACKGROUND: Andexanet Alfa (AA) is the only FDA approved reversal agent for apixaban and rivaroxaban (DOAC). There are no studies comparing its efficacy with 4-Factor Prothrombin Complex Concentrate (PCC). This study aimed to compare PCC to AA for DOAC reversal, hypothesizing non-inferiority of PCC. METHODS: We performed a retrospective, non-inferiority multicenter study of adult patients admitted from July 1, 2018 to December 31, 2019 who had taken a DOAC within 12 hours of injury, were transfused red blood cells (RBCs) or had traumatic brain injury, and received AA or PCC. Primary outcome was PRBC unit transfusion. Secondary outcome with ICU length of stay. MICE imputation was used to account for missing data and zero-inflated poisson regression was used to account for an excess of zero units of RBC transfused. 2 Units difference in RBC transfusion was selected as non-inferior. RESULTS: Results: From 263 patients at 10 centers, 77 (29%) received PCC and 186 (71%) AA. Patients had similar transfusion rates across reversal treatment groups (23.7% AA vs 19.5% PCC) with median transfusion in both groups of 0 RBC. According to the Poisson component, PCC increases the amount of RBC transfusion by 1.02 times (95% CI: 0.79-1.33) compared to AA after adjusting for other covariates. The averaged amount of RBC transfusion (non-zero group) is 6.13. Multiplying this number by the estimated rate ratio, PCC is estimated to have an increase RBC transfusion by 0.123 (95% CI: 0.53-2.02) units compared to AA. CONCLUSION: PCC appears non-inferior to AA for reversal of DOACs for RBC transfusion in traumatically injured patients. Additional prospective, randomized trials are necessary to compare PCC and AA for the treatment of hemorrhage in injured patients on DOACs. LEVEL OF EVIDENCE: Therapeutic/Care Management, Level III.

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