Hemostatic Efficacy and Safety of 4-Factor Prothrombin Complex Concentrate in Doac-Associated Intracranial Hemorrhage.

Background: Factor Xa (FXa) inhibitor use has increased over the last decade and though associated rates of major bleeding are lower compared to warfarin, outcomes from intracranial hemorrhage (ICH) are still significant. Targeted FXa inhibitor reversal agent became available in 2018, however use of 4-factor prothrombin complex concentrate (4F-PCC) for FXa inhibitor-associated ICH continues at many institutions. Objective: Evaluate the safety and hemostatic efficacy of 4F-PCC for FXa inhibitor-associated ICH. Methods: Single-center, retrospective study of patients who received 4F-PCC for FXa inhibitor-associated ICH. The primary efficacy endpoint was hemostasis and thrombosis was the main safety endpoint. Secondary endpoints included in-hospital mortality and discharge disposition. Results: 76 patients on apixaban or rivaroxaban were included. Good or excellent hemostasis was achieved in 80.3% of patients. Five patients experienced a thrombotic event. Favorable discharge disposition and lower in-hospital mortality was more likely in patients who achieved excellent hemostasis. Conclusion: 4F-PCC is safe and effective for FXa inhibitor associated ICH.