title: Comparative effectiveness of 3- versus 4-factor prothrombin complex concentrate for emergent warfarin reversal.
abstract: BACKGROUND
  Three- and 4-factor prothrombin complex concentrates (PCC) are routinely administered for emergent reversal of warfarin, but direct comparisons of clinical outcomes are lacking. The purpose of this study was to compare the safety and effectiveness of 3- and 4-PCC in patients requiring emergent warfarin reversal.
  
  
  METHODS
  This was a single-center retrospective study in adult patients requiring administration of either 3-PCC or 4-PCC for emergent reversal of warfarin.
  
  
  RESULTS
  One hundred sixty-five patients were included (3-PCC, n=109; 4-PCC, n=56). The most frequent indications for PCC were intracranial and gastrointestinal bleeding. Baseline median INR was 2.5 (2.0-3.2) and 2.4 (2.0-4.2) in the 3-PCC and 4-PCC groups. Thirty minutes after PCC administration, median INR decreased to 1.3 in both groups (p<0.001), and 87 (80%) versus 47 (84%) of patients had INR values≤1.5 (p=0.52) in the 3-PCC group versus the 4-PCC group. Thromboembolic events occurred in 7 patients (4%) and were similar between the 3-PCC (n=3, 3%) and 4-PCC (n=4, 7%) groups (p=0.23). Thirty-four (31%) patients in the 3-PCC group died compared to 5 patients (9%) in the 4-PCC group (p=0.001). INR>1.5 thirty minutes after PCC was associated with increased mortality (OR 4.3; 95% CI 1.8-10.4, p=0.001), and administration of a 4-PCC was associated with decreased mortality (OR 0.19; 95% CI 0.06-0.54, p=0.002).
  
  
  CONCLUSIONS
  Patients who received 4-PCC, and those with INR≤1.5 regardless of type of PCC received were more likely to survive. Thromboembolic events were low in both groups and similar to previous studies.
authors.affiliation: Dept of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, 1225 Center Drive, HPNP Bldg., Room 3315, P.O. Box 100486, Gainesville, FL 32610-0486, USA. Electronic address: svoils@cop.ufl.edu.
authors.forename: Stacy A
authors.initials: SA
authors.lastname: Voils
authors.affiliation: University of Florida College of Pharmacy, Clinical Pharmacy Specialist, Emergency Medicine, University of Florida Health Shands, 1600 SW Archer Road, PO Box 100316, Gainesville, FL 32610-0316, USA. Electronic address: holdmc@shands.ufl.edu.
authors.forename: Martina C
authors.initials: MC
authors.lastname: Holder
authors.affiliation: University of Florida Health Shands, 1600 SW Archer Road, PO Box 100316, Gainesville, FL 32610-0316, USA. Electronic address: premrs@shands.ufl.edu.
authors.forename: Sasha
authors.initials: S
authors.lastname: Premraj
authors.affiliation: UC Davis Medical Center, 2315 Stockton Boulevard, Sacramento, CA 95817, USA.
authors.forename: James R
authors.initials: JR
authors.lastname: Catlin
authors.affiliation: Department of Emergency Medicine, University of Florida Health Shands, 1600 SW Archer Road, PO Box 100316, Gainesville, FL 32610-0316, USA. Electronic address: brandonrallen@ufl.edu.
authors.forename: Brandon R
authors.initials: BR
authors.lastname: Allen
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects; D001779:Blood Coagulation Factors / Q000008:administration & dosage* / Q000009:adverse effects; D015897:Comorbidity; D004347:Drug Interactions; D005260:Female; D005431:Florida / Q000453:epidemiology; D006470:Hemorrhage / Q000139:chemically induced / Q000401:mortality* / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008297:Male; D011516:Prothrombin; D012307:Risk Factors; D015996:Survival Rate; D013923:Thromboembolism / Q000139:chemically induced / Q000401:mortality* / Q000517:prevention & control; D016896:Treatment Outcome; D014859:Warfarin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; D014859:Warfarin; D011516:Prothrombin
keywords: Anticoagulation reversal; Prothrombin complex concentrate; Thromboembolism; Warfarin