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Clinical Articles, Lead Article

ANNEXA 4: reversal agent shows efficacy in acute bleeding

Preliminary results in the ongoing ANNEXA-4 study have shown that andexanet can rapidly reverse anti-factor Xa activity in acutely bleeding patients and is associated with excellent or good haemostasis in most.

ANNEXA-4 (Andexanat Alfa, a Novel Antidote to the Anticoagulation Effects of FXA inhibitors) is the first study to look at andexanet in acutely bleeding patients.  The study was not randomised for ethical reasons and interim results in 67 patients, who required urgent reversal of acute major bleeding within 18 hours of receiving either a direct or indirect factor Xa inhibitor, were given andexanet alfa in a bolus over 15-30 minutes followed by a two-hour infusion.

An efficacy assessment carried out in 47 patients showed an 89% decrease in anti-factor Xa activity from baseline to end of bolus for those exposed to rivaroxaban  (n=26 ) and 93% for those exposed apixaban (n=20).   At 12 hours, clinical haemostatic efficacy was rated as good to excellent in 79% of patients.

Thrombotic events occurred in 18% of patients during the 30-day follow up. “This rate of events is not unexpected considering the thrombotic potential of the patients and the fact that in most of them anticoagulation was discontinued at the time of bleeding and not restarted,” said Dr Stuart J Connolly (McMaster University, Hamilton, Ontario, Canada) speaking at the ESC hotline session where the data was presented.

Published on: October 19, 2016

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association

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