Safety and effectiveness of Factor Eight Inhibitor Bypassing Activity for direct oral anticoagulant-related hemorrhage reversal.

BACKGROUND: The incidence of patients who present with life-threatening bleeding complications has been increasing as the use of direct oral anticoagulation (DOAC) has increased. Therefore, effective reversal agents are urgently needed. Current guidelines recommend the use of prothrombin complex concentrates (PCCs) and activated PCCs (aPCC) for reversal of DOAC anticoagulant activity in the setting of traumatic and non-traumatic intracranial hemorrhage (ICH). However, little data is available.

OBJECTIVE: Herein, we investigated the safety and effectiveness of Factor Eight Inhibitor Bypassing Activity [FEIBA (an aPCC)] in a population of patients who required emergent reversal of DOAC for hemorrhage or urgent surgical interventions.

METHODS: This is a case series study. Medical records from patients who required emergent reversal of DOAC for life threatening hemorrhage or urgent surgical interventions were collected from February 1, 2014, to April 1, 2017 and reviewed. Data, including demographics as well as safety, outcomes, and dosing of FEIBA for reversal of DOAC effects were collected and descriptive statistics were obtained.

RESULTS: Forty-two patients who received FEIBA were included in the study. The rates of thrombotic events (10%), hemorrhage progression (10%), and observed mortality (29%) were similar to rates previously published in the limited literature evaluating aPCC use in this population.

CONCLUSION: This case series suggests that FEIBA administration is relatively safe and effective to reverse DOACs in the setting of hemorrhage or need for urgent surgical procedures. Until target-specific reversal agents are available, future studies are warranted to evaluate the effectiveness of aPCC administration for DOAC-associated hemorrhagic complications.