Comparison of 4-factor prothrombin complex concentrate and andexanet alfa for reversal of apixaban and rivaroxaban in the setting of intracranial hemorrhage

J Thromb Thrombolysis. 2023 Apr;55(3):519-526. doi: 10.1007/s11239-022-02752-z. Epub 2022 Dec 25.

Abstract

The purpose of this study was to evaluate and compare clinical outcomes in patients who experienced intracranial hemorrhage (ICH) while taking apixaban or rivaroxaban and were reversed with four-factor prothrombin complex concentrates (4F-PCC) or andexanet alfa (AA). This retrospective cohort included adult patients that received 4F-PCC or AA for the initial management of an apixaban- or rivaroxaban-associated ICH. A primary outcome of excellent or good hemostatic efficacy at 12 h post-reversal was assessed. Secondary outcomes evaluated were change in hematoma volume size at 12 h, functional status at discharge, need for surgical intervention or additional hemostatic agents post-reversal, new thrombotic event within 28 days, 28-day all-cause mortality, discharge disposition, and hospital and intensive care unit lengths of stay. A total of 70 patients were included (4F-PCC, n = 47; AA, n = 23). For the primary outcome analysis, 21 patients were included in the 4F-PCC group and 12 in the AA group. The rate of effective hemostasis was similar between the 4F-PCC and AA groups (66.7% vs 75%, p = 0.62). There were no statistically significant differences between the groups for secondary outcomes, including 28-day mortality (40.4% vs 39.1%, p = 0.92) and thrombotic complications within 28 days of reversal (17.0% vs 21.7%, p = 0.63). In patients who experienced an ICH while taking apixaban or rivaroxaban, 4F-PCC and AA were found to have similar rates of excellent or good hemostatic efficacy.

Keywords: Andexanet alfa; Anticoagulation reversal; Factor Xa inhibitor; Hemostatic efficacy; Intracranial hemorrhage; Prothrombin complex concentrate.

MeSH terms

  • Adult
  • Anticoagulants
  • Blood Coagulation Factors / therapeutic use
  • Factor IX
  • Factor Xa
  • Factor Xa Inhibitors / adverse effects
  • Hemorrhage
  • Hemostatics*
  • Humans
  • Intracranial Hemorrhages / chemically induced
  • Intracranial Hemorrhages / drug therapy
  • Recombinant Proteins
  • Retrospective Studies
  • Rivaroxaban / adverse effects
  • Thrombosis*

Substances

  • prothrombin complex concentrates
  • Rivaroxaban
  • PRT064445
  • apixaban
  • Blood Coagulation Factors
  • Factor Xa
  • Hemostatics
  • Factor IX
  • Factor Xa Inhibitors
  • Anticoagulants
  • Recombinant Proteins