Journal article
Four-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
The journal of trauma and acute care surgery, Vol.97(4), pp.541-545
01 Oct 2024
PMID: 38685190
Featured in Collection : UN Sustainable Development Goals @ Drexel
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 four-factor prothrombin complex concentrate (PCC). This study aimed to compare PCC to AA for DOAC reversal, hypothesizing noninferiority of PCC.
METHODS: We performed a retrospective, noninferiority 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 intensive care unit 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. Two units difference in RBC transfusion was selected as noninferior.
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% confidence interval, 0.79-1.33) compared with AA after adjusting for other covariates. The average amount of RBC transfusion (nonzero 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% confidence interval, 0.53-2.02) units compared with AA.
CONCLUSION: PCC appears noninferior 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.
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Details
- Title
- Four-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
- Creators
- Jordan M. Estroff - George Washington UniversityJoseph Devlin - George Washington UniversityLara Hoteit - University of Pittsburgh Medical CenterAdnan Hassoune - University of Pittsburgh Medical CenterMatthew D. Neal - University of Pittsburgh Medical CenterJoshua B. Brown - University of Pittsburgh Medical CenterLiling Lu - University of Pittsburgh Medical CenterShannon Kotch - Penn State Milton S. Hershey Medical CenterJoshua P. Hazelton - Penn State Milton S. Hershey Medical CenterAshton B. Christian - University of California, IrvineEric O. Yeates - University of California, IrvineJeffry Nahmias - University of California, IrvineLewis E. Jacobson - St Vincent HospitalJamie Williams - St Vincent HospitalKevin M. Schuster - Yale UniversityRick O'Connor - Yale UniversityGregory R. Semon - Wright State UniversityAngela D. Straughn - Miami Valley HospitalDaniel Cullinane - Maine Medical CenterTanya Egodage - Grant Medical CenterMichelle Kincaid - Grant Medical CenterAllison Rollins - Grant Medical CenterRichard Amdur - George Washington UniversityBabak Sarani - George Washington University
- Publication Details
- The journal of trauma and acute care surgery, Vol.97(4), pp.541-545
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 5
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Surgery
- Web of Science ID
- WOS:001319556100020
- Scopus ID
- 2-s2.0-85205083357
- Other Identifier
- 991022056906504721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Critical Care Medicine
- Surgery