title: Is there a difference in efficacy, safety, and cost-effectiveness between 3-factor and 4-factor prothrombin complex concentrates among trauma patients on oral anticoagulants?
abstract: The aim of this study was to compare the efficacy, safety, and cost-effectiveness of 3-factor prothrombin complex concentrate (3F-PCC) vs 4-factor prothrombin complex concentrate PCC (4F-PCC) in trauma patients requiring reversal of oral anticoagulants.
  
  
  
  All consecutive trauma patients with coagulopathy (international normalized ratio [INR] ≥1.5) secondary to oral anticoagulants who received either 3F-PCC or 4F-PCC from 2010 to 2014 at 2 trauma centers were reviewed. Efficacy was determined by assessing the first INR post-PCC administration, and successful reversal was defined as INR less than 1.5. Safety was assessed by reviewing thromboembolic events, and cost-effectiveness was calculated using total treatment costs (drug acquisition plus transfusion costs) per successful reversal.
  
  
  
  Forty-six patients received 3F-PCC, and 18 received 4F-PCC. Baseline INR was similar for 3F-PCC and 4F-PCC patients (3.1 ± 2.3 vs 3.4 ± 3.7, P = .520). The initial PCC dose was 29 ± 9 U/kg for 3F-PCC and 26 ± 6 U/kg for 4F-PCC (P = .102). The follow-up INR was 1.6 ± 0.6 for 3F-PCC and 1.3 ± 0.2 for 4F-PCC (P = .001). Successful reversal rates in patients were 83% for 4F-PCC and 50% for 3F-PCC (P = .022). Thromboembolic events were observed in 15% of patients with 3F-PCC vs 0% with 4F-PCC (P = .177). Cost-effectiveness favored 4F-PCC ($5382 vs $3797).
  
  
  
  Three-factor PCC and 4F-PCC were both safe in correcting INR, but 4F-PCC was more effective, leading to better cost-effectiveness. Replacing 3F-PCC with 4F-PCC for urgent coagulopathy reversal may benefit patients and institutions.
authors.affiliation: HonorHealth John C. Lincoln Medical Center. Electronic address: Alicia.Mangram@HonorHealth.com.
authors.forename: Alicia
authors.initials: A
authors.lastname: Mangram
authors.affiliation: HonorHealth John C. Lincoln Medical Center. Electronic address: Francis.Oguntodu@HonorHealth.com.
authors.forename: Olakunle F
authors.initials: OF
authors.lastname: Oguntodu
authors.affiliation: HonorHealth John C. Lincoln Medical Center. Electronic address: James.Dzandu@HonorHealth.com.
authors.forename: James K
authors.initials: JK
authors.lastname: Dzandu
authors.affiliation: HonorHealth John C. Lincoln Medical Center. Electronic address: Alexzandra.Hollingworth@HonorHealth.com.
authors.forename: Alexzandra K
authors.initials: AK
authors.lastname: Hollingworth
authors.affiliation: Department of Pharmacy Services, HonorHealth John C. Lincoln Medical Center. Electronic address: scott.hall@HonorHealth.com.
authors.forename: Scott
authors.initials: S
authors.lastname: Hall
authors.affiliation: Department of Pharmacy Services, HonorHealth John C. Lincoln Medical Center. Electronic address: Christina.cung@HonorHealth.com.
authors.forename: Christina
authors.initials: C
authors.lastname: Cung
authors.affiliation: Department of Pharmacy Services, HonorHealth John C. Lincoln Medical Center. Electronic address: Jason.rodriguez@HonorHealth.com.
authors.forename: Jason
authors.initials: J
authors.lastname: Rodriguez
authors.affiliation: Neurosurgery Department, HonorHealth John C. Lincoln Medical Center. Electronic address: Igor.Yusupov@HonorHealth.com.
authors.forename: Igor
authors.initials: I
authors.lastname: Yusupov
authors.affiliation: Midwestern University, College of Pharmacy-Glendale. Electronic address: jbarle@midwestern.edu.
authors.forename: Jeffrey F
authors.initials: JF
authors.lastname: Barletta
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects; D001778:Blood Coagulation Disorders / Q000097:blood / Q000188:drug therapy*; D002118:Calcium / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D003422:Critical Care; D005260:Female; D006490:Hemostatics / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D012189:Retrospective Studies; D012449:Safety; D013925:Thromboplastin / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D014193:Trauma Centers; D014859:Warfarin / Q000009:adverse effects; D014947:Wounds and Injuries
chemical_list: D000925:Anticoagulants; D006490:Hemostatics; D014859:Warfarin; D013925:Thromboplastin; D002118:Calcium
keywords: Anticoagulation; Geriatric; Prothrombin complex concentrates; Reversal; Trauma; Warfarin