(1360) Impact of Timing of 4F-PCC Administration on Outcomes in Oral Factor Xa Inhibitor-Associated ICH

Introduction: Unlike the well-defined ischemic stroke target imaging and thrombolytic administration times, there is no target time-to-administration of a reversal agent for anticoagulant-related intracerebral hemorrhage (ICH). According to the most recent ICH guidelines, reversal should take place "rapidly" and "as soon as possible". Prior data has been examined evaluating time to reversal in patients taking vitamin K antagonists and in patients taking any anticoagulant, but not in our more commonly used agents, oral factor Xa inhibitors. The purpose of this study was to evaluate the impact of time-to-administration of a reversal agent, Four Factor Prothrombin Complex Concentrate (4F-PCC), on outcomes in patients with ICH taking oral factor Xa inhibitors.

Methods: This was a retrospective, multi-site, observational study. Included patients were adults ≥ 18 years of age, with presence of ICH on imaging, currently taking an oral factor Xa inhibitor who received 4F-PCC for reversal of their intracranial hemorrhage. Patients were stratified based on time-to-administration of 4F-PCC. The primary outcome was defined as rates of hematoma expansion. Secondary outcomes included hematoma expansion at any time during hospitalization, hemostatic efficacy, incidence of neurosurgical interventions, rates of venous thromboembolism during hospitalization, functional status at discharge, and death due to a neurologic outcome.

Results: A total of 319 patients were screened and 40 patients were included in this study. The primary outcome of hematoma expansion was not statistically significantly different (0-60 min, 61-120 min, 121-180 min, 181-240 min, 241+ min; 67%, 77%, 36%, 71%, 33%, p=0.191). There were no differences among secondary outcomes including hemostatic efficacy, rates of venous thromboembolism during hospitalization, functional status at discharge, death due to neurologic injury, intensive care unit (ICU) length of stay (LOS), and hospital LOS.

Conclusions: In conclusion, our study examining time-to-administration of 4F-PCC found no significant difference in outcomes for oral factor Xa inhibitor-associated ICH. In our cohort, most patients had a low ICH score and high GCS. More data in this area is needed to elucidate the optimal time goals for reversal in managing patients with oral factor Xa-associated ICH.