Evaluating the use of fixed versus variable dosing of 4-factor prothrombin complex concentrate in anticoagulant-related major bleeding.

BACKGROUND/

OBJECTIVE

4-factor prothrombin complex concentrate (4F-PCC) is used for reversal of vitamin K antagonists (VKA) and oral factor Xa (FXa) inhibitors in patients with major bleeding, including gastrointestinal bleeding and intracranial hemorrhage (ICH), and in those requiring emergent surgical intervention. Fixed dose 4F-PCC may offer the advantage of decreased cost and simplified administration. The objective of this study was to evaluate the effectiveness of fixed dose versus variable dose 4F-PCC in the achievement of hemostasis in VKA and FXa-associated major bleeding.

METHODS

Single-center, retrospective cohort study of patients who received 4F-PCC from January 1, 2018 through August 31, 2023. The primary outcome of effective hemostasis was based on the International Society on Thrombosis and Hemostasis definition.

RESULTS

Overall, baseline characteristics were similar between groups. The primary endpoint of effective hemostasis was achieved by 57 % of patients in the fixed dose group and 53 % of patients in the variable dose group (Risk difference [RD] 3.7 %, 95 % CI -14.5 to 22.0). The incidence of thromboembolic events within 7 days of 4F-PCC was lower in the fixed dose group compared with the variable dose group, at 4.2 % and 10.6 %, respectively (RD 6.4 %, 95 % CI -16.4 to 3.5). The average cost of 4F-PCC was $7023 in the fixed dose group versus $11,311 in the variable dose group with a between-group difference of $4288 (95 % CI 3150 to 5425). These results were consistent across all types and severities of anticoagulant-associated major bleeding.

CONCLUSIONS

In this study, fixed dose 4F-PCC was as effective as variable dose 4F-PCC in the achievement of hemostatic efficacy for VKA and FXa-associated major bleeding with a significantly lower overall cost.