Emergent external ventricular drain placement in patients with factor Xa inhibitor-associated intracerebral hemorrhage after reversal with andexanet alfa

Clin Neurol Neurosurg. 2023 Mar:226:107621. doi: 10.1016/j.clineuro.2023.107621. Epub 2023 Feb 9.

Abstract

Background: Andexanet alfa (AA), a factor Xa-inhibitor (FXi) reversal agent, is given as a bolus followed by a 2-hour infusion. This long administration time can delay EVD placement in intracerebral hemorrhage (ICH) patients. We sought to evaluate the safety of EVD placement immediately post-AA bolus compared to post-AA infusion.

Methods: We conducted a retrospective study that included adult patients admitted with FXi-associated ICH who received AA and underwent EVD placement The primary outcome was the occurrence of a new hemorrhage (tract, extra-axial, or intraventricular hemorrhage). Secondary outcomes included mortality, intensive care unit and hospital length of stay, and discharge modified Rankin Score. The primary safety outcome was documented thrombotic events.

Results: Twelve patients with FXi related ICH were included (EVD placement post-AA bolus, N = 8; EVD placement post-AA infusion, N = 4). Each arm included one patient with bilateral EVD placed. There was no difference in the incidence of new hemorrhages, with one post-AA bolus patient had small, focal, nonoperative extra-axial hemorrhage. Morbidity and mortality were higher in post-AA infusion patients (mRS, post-AA bolus, 4 [4-6] vs. post-AA infusion 6 [5,6], p = 0.24 and post-AA bolus, 3 (37.5 %) vs. post-AA infusion, 3 (75 %), p = 0.54, respectively). One patient in the post-AA bolus group had thrombotic event. There was no difference in hospital LOS (post-AA bolus, 19 days [12-26] vs. post-AA infusion, 14 days [9-22], p = 0.55) and ICU LOS (post-AA bolus, 10 days [6-13] vs. post-AA infusion, 11 days [5-21], p = 0.86).

Conclusion: We report no differences in the incidence of tract hemorrhage, extra-axial hemorrhage, or intraventricular hemorrhage post-AA bolus versus post-AA infusion. Larger prospective studies to validate these results are warranted.

Keywords: Andexanet alpha; Anticoagulation; Hemorrhagic stroke; Intracerebral hemorrhage; Neurosurgical procedures.

MeSH terms

  • Adult
  • Cerebral Hemorrhage / surgery
  • Drainage / methods
  • Factor Xa Inhibitors
  • Factor Xa*
  • Fibrinolytic Agents
  • Humans
  • Prospective Studies
  • Recombinant Proteins
  • Retrospective Studies
  • Thrombosis*

Substances

  • PRT064445
  • Factor Xa
  • Factor Xa Inhibitors
  • Fibrinolytic Agents
  • Recombinant Proteins