Three- versus four-factor prothrombin complex concentrate for the reversal of warfarin-induced bleeding
Tara Holt1, Scott Taylor2, Prasad Abraham3, Wesley Mcmillian4, Serena Harris5, James Curtis6, Tai Elder2
1 Department of Pharmacy, IU Health Methodist Hospital, Indianapolis, IN, USA
2 Department of Pharmacy, Via Christi Hospitals, Wichita, KS, USA
3 Department of Pharmacy, Grady Health System, Atlanta, GA, USA
4 Department of Pharmacy, Fletcher Allen Health Care, Burlington, VT, USA
5 Department of Pharmacy, Eskenazi Health, Indianapolis, IN, USA
6 Department of Pharmacy, Bronson Methodist Hospital, Kalamazoo, MI, USA
Dr. Tara Holt
Department of Pharmacy, IU Health Methodist Hospital, 1701 N. Senate Blvd, AG 401, Indianapolis, IN 46202
Source of Support: None, Conflict of Interest: None
Objective: The objective of this study was to evaluate the effectiveness of 3-factor prothrombin complex concentrate (3F-PCC) compared to 4-factor PCC (4F-PCC) in warfarin-associated bleeding.
Methods: This multicenter, retrospective, cohort study analyzed data from patients admitted between May 2011 and October 2014 who received PCC for warfarin-associated bleeding. The primary outcome was the rate of international normalized ratio (INR) normalization, defined as an INR ≤1.3, after administration of 3F-PCC compared to 4F-PCC. Other variables of interest included the incidence of additional reversal agents, new thromboembolic events, and mortality.
Results: A total of 134 patients were included in the analysis. The average dose of PCC administered was 24.6 ± 9.3 units/kg versus 36.3 ± 12.8 units/kg in the 3F-PCC and 4F-PCC groups, respectively, P < 0.001. Baseline INR in the 3F-PCC and 4F-PCC groups was 3.61 ± 2.3 and 6.87 ± 2.3, respectively P < 0.001. 4F-PCC had a higher rate of INR normalization at first INR check post-PCC administration compared to 3F-PCC (84.2% vs. 51.9%, P = 0.0001). Thromboembolic events, intensive care unit and hospital length of stay, and mortality were similar among both groups.
Conclusion: The use of 4F-PCC leads to a more significant reduction in INR compared to 3F-PCC though no difference in mortality or length of stay was observed. Thromboembolism rates were similar among both groups.