Comparison of 4F-PCC and andexanet alfa for the reversal of direct factor Xa inhibitors
Reversal agent . | 4F-PCC . | Andexanet alfa . |
---|---|---|
Mechanism of action | Reverses PT and endogenous thrombin generation; indirect, nonspecific pro-hemostatic | Acts as a “decoy” via binding and sequestering the factor Xa inhibitors Direct specific antidote |
Dose | 50 U/kg for major bleeding or a fixed dose of 2000 U used for simplicity | Dose depends on the dose and timing of the last dose of the FXa inhibitor* Low dose: 400 mg intravenous bolus at 30 mg/min, followed by infusion of 480 mg at 4 mg/min for up to 2 h High dose: 800 mg intravenous bolus at 30 mg/min, followed by infusion of 960 mg 8 mg/min for up to 2 h |
Availability | Readily available at most hospitals | Limited availability |
Rate of effective management of major bleeding (95% CI) | With the ISTH criteria: 69% (61%-76%) Not using the ISTH criteria: 75% (53%-97%)70 | 83% (75%-89%)69 |
Rate of thromboembolic complications (95% CI) | 5% (1%-9%)70 | 11% (NA)69 |
Cost | $1.27† per unit71 For 2000 U 4F-PCC $2540 | $3300 per vial of 100 mg72 Low dose (9 vials) $29 700, high dose (18 vials) $59 400 |
Reversal agent . | 4F-PCC . | Andexanet alfa . |
---|---|---|
Mechanism of action | Reverses PT and endogenous thrombin generation; indirect, nonspecific pro-hemostatic | Acts as a “decoy” via binding and sequestering the factor Xa inhibitors Direct specific antidote |
Dose | 50 U/kg for major bleeding or a fixed dose of 2000 U used for simplicity | Dose depends on the dose and timing of the last dose of the FXa inhibitor* Low dose: 400 mg intravenous bolus at 30 mg/min, followed by infusion of 480 mg at 4 mg/min for up to 2 h High dose: 800 mg intravenous bolus at 30 mg/min, followed by infusion of 960 mg 8 mg/min for up to 2 h |
Availability | Readily available at most hospitals | Limited availability |
Rate of effective management of major bleeding (95% CI) | With the ISTH criteria: 69% (61%-76%) Not using the ISTH criteria: 75% (53%-97%)70 | 83% (75%-89%)69 |
Rate of thromboembolic complications (95% CI) | 5% (1%-9%)70 | 11% (NA)69 |
Cost | $1.27† per unit71 For 2000 U 4F-PCC $2540 | $3300 per vial of 100 mg72 Low dose (9 vials) $29 700, high dose (18 vials) $59 400 |