title: 3-Factor Versus 4-Factor Prothrombin Complex Concentrate for Warfarin Reversal in Severe Bleeding: A Multicenter, Retrospective, Propensity-Matched Pilot Study.
abstract: Current guidelines recommend 4-factor prothrombin complex concentrate (4PCC) for emergent reversal of bleeding secondary to warfarin. While current research has demonstrated superiority of 4PCC over plasma, direct comparisons with 3-factor PCC (3PCC) are lacking. The purpose of this study is to compare the efficacy and safety of 3PCC and 4PCC. We conducted a retrospective analysis of patients who received PCC at one of four medical centers. All patients in the 3PCC group were treated at one center that utilizes a fixed, weight-based dosing protocol. After evaluation of all patients meeting inclusion criteria, propensity-score matching was used to adjust for differences in treatment characteristics. There was no difference in the primary outcome of INR ≤ 1.4 between 3PCC and 4PCC in both the unmatched (85.7 vs. 90.6 %; p = 0.37) and matched (84.2 vs. 92.1 %; p = 0.48) analyses. There was a significant difference in goal INR achieved favoring 4PCC (56.3 vs 90.0 %; p < 0.02) when baseline INR > 4.0. A total of three thrombotic events were documented, all in the 4PCC group. We found no difference in the rate of INR reversal in those treated with 3PCC and 4PCC. However, those with a baseline INR > 4.0 may experience more successful INR reversal with 4PCC.
authors.affiliation: Department of Pharmacy, Methodist University Hospital, 1265 Union Avenue, Memphis, TN, 38104, USA. morgan.jones@mlh.org.|Department of Clinical Pharmacy, University of Tennessee Health Sciences Center (UTHSC), 920 Court Ave, Memphis, TN, 38163, USA. morgan.jones@mlh.org.|Department of Neurology and Neurosurgery, UTHSC, 920 Court Ave, Memphis, TN, 38163, USA. morgan.jones@mlh.org.
authors.forename: G Morgan
authors.initials: GM
authors.lastname: Jones
authors.affiliation: Department of Pharmacy, University of Florida Health, 655 West 8th Street, Jacksonville, FL, 32209, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Erdman
authors.affiliation: Department of Pharmacy, University of Kentucky HealthCare, 800 Rose St, Lexington, KY, 40536, USA.
authors.forename: Keaton S
authors.initials: KS
authors.lastname: Smetana
authors.affiliation: Department of Pharmacy, Temple University Hospital, 3509 N Broad St, Philadelphia, PA, 19140, USA.
authors.forename: Kerry M
authors.initials: KM
authors.lastname: Mohrien
authors.affiliation: Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, 620 W Lexington St, Baltimore, MD, 21201, USA.
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Vandigo
authors.affiliation: Department of Neurology and Neurosurgery, UTHSC, 920 Court Ave, Memphis, TN, 38163, USA.|Semmes-Murphey Neurologic and Spine Institute, 6325 Humphreys Blvd, Memphis, TN, 38120, USA.
authors.forename: Lucas
authors.initials: L
authors.lastname: Elijovich
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects*; D001779:Blood Coagulation Factors / Q000008:administration & dosage* / Q000737:chemistry / Q000494:pharmacology / Q000627:therapeutic use; D004347:Drug Interactions; D006470:Hemorrhage / Q000139:chemically induced* / Q000188:drug therapy; D006801:Humans; D019934:International Normalized Ratio; D010865:Pilot Projects; D057216:Propensity Score; D012189:Retrospective Studies; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects*
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; D014859:Warfarin
keywords: Anticoagulation therapy; Hematology; Hemorrhagic disorders; Prothrombin