What is the role of coagulation factor Xa recombinant (AndexXa) in perioperative anticoagulation management?

Updated: May 08, 2018
  • Author: Brian J Daley, MD, MBA, FACS, FCCP, CNSC; Chief Editor: William A Schwer, MD  more...
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In May 2018, coagulation factor Xa recombinant (AndexXa) was approved for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding. Approval was supported by data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A), which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy older volunteers. Results demonstrated a rapid and significant reversal of anti-Factor Xa (FXa) activity. Anti-FXa activity was reduced among apixaban-treated participants by 94% compared with 21% for placebo (p<0.001). A 92% reduction of anti-FXa activity was observed in the rivaroxaban-treated participants compared with 18% for placebo (p<0.001).<ref>23</ref>

In the ANNEXA-4 trial, 67 patients who had acute major bleeding within 18 hr after administration of an FXa inhibitor received coagulation factor Xa recombinant. After the IV bolus plus 2 hour IV infusion, the median anti-FXa activity decreased by 89% from baseline among patients receiving rivaroxaban and by 93% among patients receiving apixaban. Assessment at 12 hours after the infusion adjudicated clinical hemostasis as excellent or good in 37 of 47 patients in the efficacy analysis (79%; 95% CI, 64 to 89). Thrombotic events occurred in 12 of 67 patients (18%) during the 30-day follow-up. [24]


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