• Am J Emerg Med · Jun 2017

    Comparative Study

    Comparison of the safety and efficacy between 3-factor and 4-factor prothrombin complex concentrates for the reversal of warfarin.

    • Julia E Kuroski and Sarah Young.
    • Department of Pharmacy, Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA 15212, United States. Electronic address: jkuroski59@gmail.com.
    • Am J Emerg Med. 2017 Jun 1; 35 (6): 871-874.

    PurposePrior to the Food and Drug Administration approval of 4-factor prothrombin complex concentrate (4F-PCC), only 3-factor PCC (3F-PCC) products were available in the US. There is limited data comparing the safety and efficacy of 3F-PCC versus 4F-PCC. The purpose of our study, therefore, was to compare the safety and efficacy profiles of 3F-PCC versus 4F-PCC for the emergent reversal of warfarin.MethodsA single-center, retrospective cohort analysis compared patients who received 3F-PCC or 4F-PCC for the emergent reversal of warfarin due to life-threating bleeding from January 2013 to September 2015. The primary objective of this study was the percentage of patients whose international normalized ratio (INR) reversed to ≤1.5 within 8h of PCC administration. The secondary safety objective was incidence of thromboembolic events at 7days post PCC.ResultsA total of 137 patients were included. The median baseline INR was 3.15 in the 3F-PCC group and 3.1 in the 4F-PCC group. The median post-PCC INR was 1.4 in the 3F-PCC group and 1.3 in the 4F-PCC group. INR ≤1.5 was achieved in 45/58 (78%) patients in the 3F-PCC group and 46/58 (79%) patients in the 4F-PCC group (p=0.61). The thromboembolic event rate between the two groups at 7days was similar, 4/68 (5.9%) for 3F-PCC versus 4/69 (5.8%) for 4F-PCC (p=1.0).ConclusionsThere was no significant difference in the percentage of patients who achieved an INR ≤1.5 between the 3F-PCC and 4F-PCC groups for emergent reversal of warfarin.Copyright © 2017 Elsevier Inc. All rights reserved.

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