Evaluation of Warfarin Reversal with 4-Factor Prothrombin Complex Concentrate Compared to 3-Factor Prothrombin Complex Concentrate at a Tertiary Academic Medical Center

Abstract Background The U.S. Food and Drug Administration recently approved a four-factor prothrombin complex concentrate (4-PCC) for warfarin reversal. The literature supporting its use over three-factor prothrombin complex concentrate (3-PCC) is limited. Objective Our objective was to retrospectiv...

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Bibliographic Details
Published in:The Journal of emergency medicine 2016-01, Vol.50 (1), p.7-13
Main Authors: Al-Majzoub, Omar, PharmD, Rybak, Eva, PharmD, BCPS, Reardon, David P., PharmD, BCPS, Krause, Patricia, PharmD, BCPS, Connors, Jean M., MD
Format: Article
Language:English
Subjects:
Academic Medical Centers
Aged
Aged, 80 and over
Anticoagulants - adverse effects
anticoagulation reversal
Blood Coagulation Factors - pharmacology
Blood Coagulation Factors - therapeutic use
Cohort Studies
Emergency
Female
Gastrointestinal Hemorrhage - chemically induced
Gastrointestinal Hemorrhage - drug therapy
Humans
INR
International Normalized Ratio
Intracranial Hemorrhages - chemically induced
Intracranial Hemorrhages - drug therapy
Male
prothrombin complex concentrate
Retrospective Studies
warfarin
Warfarin - adverse effects
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Summary:Abstract Background The U.S. Food and Drug Administration recently approved a four-factor prothrombin complex concentrate (4-PCC) for warfarin reversal. The literature supporting its use over three-factor prothrombin complex concentrate (3-PCC) is limited. Objective Our objective was to retrospectively compare the efficacy of 3-PCC to 4-PCC in reversing warfarin in patients who were actively bleeding. Methods We conducted a single-center, retrospective cohort analysis of adult patients who received 3-PCC or 4-PCC for international normalized ratio (INR) reversal. Our study excluded patients not actively bleeding and not on warfarin. The main outcome was the percentage of patients who achieved warfarin reversal defined as INR ≤ 1.3 at first INR check post factor administration. We recorded baseline data including PCC dose, location of bleed, pre- and posttreatment INR, and time to INR reversal. Results We included a total of 53 patients. Intracranial hemorrhage was the most common site of bleeding (26 [74.3%] in 3-PCC vs. 12 [66.7%] in 4-PCC). The mean dose of 3-PCC was 25.5 units/kg, compared to 27.9 units/kg of 4-PCC. The mean baseline INR was 2.3 in the 3-PCC group and 3 in the 4-PCC group ( p = 0.03), and the first posttreatment INRs were 1.4 and 1.2, respectively ( p < 0.01). Warfarin reversal was achieved in 15 (42.9%) patients who received 3-PCC and 15 (83.3%) patients who received 4-PCC ( p < 0.01). Faster time to INR reversal was noted in the 4-PCC group vs. the 3-PCC group (3.7 vs. 5 h, p = 0.48). Conclusion A higher percentage of patients achieved warfarin reversal with 4-PCC compared to 3-PCC treatment. A prospective randomized control trial is necessary to confirm our results.
ISSN:0736-4679
2352-5029
DOI:10.1016/j.jemermed.2015.07.024