The outcomes of three-factor prothrombin complex concentrate (3F-PCC) in warfarin anticoagulation reversal: a prospective, single-arm, open-label, multicentre study.

Abstract

There is a wide variation on the efficacy of three-factor Prothrombin Complex Concentrate (3F-PCC) in warfarin reversal. We aimed to determine the efficacy and safety of 3F-PCC in warfarin reversal. This multicentre prospective study analysed data from adult patients on warfarin who received 3F-PCC (Prothrombinex-VF®) for anticoagulation reversal between June 2019 to October 2020. Purposive sampling was used in this study. Study endpoints included target INR achievement, adverse drug reactions (ADRs), and in-hospital all-cause mortality. Logistic regression analyses were used to assess independent predictors of study endpoints. One-hundred thirty-seven patients with a median age of 68 (59-76) years were recruited, who were predominantly male (59.9%, n = 82). A total of 102 patients required 3F-PCC for life-threatening (40.9%, n = 56) and clinically significant bleeding (33.6%, n = 46). Initial INRs ranged from 1.55 to undetectable high (> 26). All patients had INR reduction, of which 62% (n = 85) achieved target INR, whereas 12.4% (n = 17) achieved INR below the target range. Median INR was reduced from 4.76 (3.14-8.32) to 1.54 (1.27-1.88) post-3F-PCC (p < 0.001). The use of adjunctive reversal agents and initial INR < 3.6 were the significant predictors for target INR achievement. Six (4.4%) ADRs were observed. Two (1.5%) cases with the suspected acute coronary syndrome were associated with mortality. Ischemic stroke occurred in one (0.7%) patient. The incidence of in-hospital all-cause mortality was 21.2% (n = 29). The rate of INR achievement was 62% in our study without apparent increased risk of thromboembolic events and in-hospital all-cause mortality.