Comparison of 4f-PCC and and-exanet alfa for reversal of apixaban- and rivaroxaban-associated ICH
Introduction/Hypothesis: Four-factor prothrombin complex concentrates (4F-PCC) and andexanet alfa are two reversal agents commonly used in the management of intracranial hemorrhage (ICH) associated with oral factor-Xa inhibitor use. The limited data available has not identified an agent with superior clinical efficacy. The purpose of this study was to evaluate and compare clinical outcomes in patients who experienced an ICH while taking apixaban or rivaroxaban and were reversed with 4F-PCC or andexanet alfa.
Methods: This retrospective cohort included adult patients that received 4F-PCC or andexanet alfa for the initial management of an apixaban- or rivaroxaban-associated ICH. Patients that received 4F-PCC or andexanet alfa for any other indication were excluded. A primary outcome of excellent or good hemostatic efficacy at 12 hours post-reversal was assessed. Secondary outcomes evaluated were change in hematoma volume size at 12 hours, functional status at discharge, the need for surgical intervention or additional hemostatic agents post-reversal, new thrombotic event within 30 days, 28-day all-cause mortality, discharge disposition, and hospital and intensive care unit (ICU) lengths of stay.
Results: Seventy patients were included in this study (4F-PCC, n = 47; andexanet alfa, n = 23). Median baseline hematoma volumes were similar between the 4F-PCC and andexanet alfa groups (15.7 vs 22.3 mL, p = 0.25). Baseline ICH scores were significantly higher in the andexanet alfa group (2 vs 3, p = 0.03). For the primary outcome, 21 patients were included in the 4F-PCC group and 12 in the andexanet alfa group. The rate of effective hemostasis was similar between the 4F-PCC and andexanet alfa groups (66.7% vs 75%, p = 0.62). There were no statistically significant differences between the groups for secondary outcomes, including 28-day mortality and thrombotic complications within 30 days of reversal.
Conclusions: In patients who experienced an ICH while taking apixaban or rivaroxaban, 4F-PCC and andexanet alfa were found to have similar rates of excellent or good hemostatic efficacy.
Critical Care Medicine
Lipski, Michelle; Pasciolla, Stacy; Wojcik, Kevin; Jankowitz, Brian; and Igneri, Lauren, "Comparison of 4f-PCC and and-exanet alfa for reversal of apixaban- and rivaroxaban-associated ICH" (2022). Neurosurgery Resident Research. 15.