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?

Purpose: The aim of this study was to compare the efficacy, safety, and cost-effectiveness of 3-factor prothrombin complex concentrate (31-PCC) vs 4-factor prothrombin complex concentrate PCC (41-PCC) in trauma patients requiring reversal of oral anticoagulants. Materials and methods: All consecutive trauma patients with coagulopathy (international normalized ratio [INR] 15) secondary to oral anticoagulants who received either 31-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. Results: Forty-six patients received 3F-PCC, and 18 received 4F-PCC. Baseline INR was similar for 3F-PCC and 4F-PCC patients (3.1 +/- 23 vs 34 3.7, P = .520). The initial PCC dose was 29 9 U/kg for 3F-PCC and 26 +/- 61.1/1(g for 4F-PCC (P = .102). The follow-up INR was 1.6 +/- 0.6 for 3F-PCC and 1.3 +/- 02 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 31-PCC vs 0% with 4P-PCC (P = .177). Cost-effectiveness favored 41-PCC ($5382 vs $3797). Conclusions: Three-factor PCC and 4F-PCC were both safe in correcting INR, but 41-PCC was more effective, leading to better cost-effectiveness. Replacing 3P-PCC with 4F-PCC for urgent coagulopathy reversal may benefit patients and institutions. (C) 2016 Elsevier Inc. All rights reserved.