Comparison of high- and low-dose 4-factor prothrombin complex concentrate for the emergent reversal of oral Factor Xa inhibitors

Even though there are several reversal strategies available for oral Factor Xa inhibitor associated coagulopathies, 4-factor prothrombin complex concentrate (4F-PCC) is used commonly as the primary reversal agent at many institutions. A dose of 50 units/kg is recommended as safe and effective with growing data suggesting that a lower dosing strategy may be sufficient. This retrospective study included adult patients who received either high-dose (50 units/kg; maximum dose: 5000 units) or low-dose (25 units/kg; maximum dose: 2500 units) 4F-PCC for the emergent reversal of oral Factor Xa inhibitor-related life threatening bleeding. The primary outcome was the attainment of hemostatic effectiveness. Secondary outcomes were rates of thromboembolic events and inpatient mortality. 47 patients were included in the analysis of which 24 patients received high-dose and 23 patients received low-dose 4F-PCC. Overall hemostatic effectiveness was 87.5% in the high-dose group and 91.3% in the low-dose group. Thromboembolic event rate was 8.3% in the high-dose group compared to 4.4% within the low-dose group and inpatient mortality rate was 8.3% in the high-dose group and 4.4% in the low-dose group. Low-dose 4F-PCC (25 units/kg, maximum dose: 2500 units) for the reversal of oral Factor Xa inhibitors is a cost-effective alternative to high-dose 4F-PCC (50 units/kg; maximum dose: 5000 units) and provides effective hemostasis without increased rates of thromboembolic events or inpatient mortality.