english.prescrire.org > Spotlight > Archives : 2020 > Andexanet alfa (Ondexxya°) as an antidote to xabans: inadequate clinical evaluation

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Andexanet alfa (Ondexxya°) as an antidote to xabans: inadequate clinical evaluation

FEATURED REVIEW The evaluation of andexanet alfa for the management of severe bleeding in patients receiving apixaban or rivaroxaban is inadequate. When bleeding occurs in a patient receiving a xaban, the key action is to put in place proven emergency supportive measures.
Full review (4 pages) available for download by subscribers.

  • Xabans such as apixaban or rivaroxaban are oral factor Xa inhibitors, anticoagulants used for the prevention and treatment of venous or arterial thromboembolic events.
     
  • The treatment of severe haemorrhage in a patient receiving a xaban involves a combination of anticoagulant withdrawal and emergency supportive measures, particularly actions to stop the bleeding, correction of hypovolaemia and transfusion of labile blood products.
     
  • Andexanet alfa is a modified factor Xa, lacking enzymatic activity. It has been authorised in the European Union as an antidote for use in patients with severe bleeding who are receiving apixaban or rivaroxaban.
     
  • Its evaluation comprises a single, non-comparative clinical trial in 352 patients who had major bleeding while receiving a factor Xa inhibitor. All the patients received andexanet alfa. After one month, 15% of the patients had died. None of the analyses provided enables the potential clinical effectiveness of andexanet alfa in controlling haemorrhage to be demonstrated or evaluated.
     
  • 10% of the patients enrolled in this trial had at least one thromboembolic event during the 30 days following the infusion. It is not known whether these events were linked to withdrawal of the anticoagulant in patients at risk of thrombosis, or to a procoagulant effect of andexanet alfa. Andexanet alfa carries a risk of infusion reactions.
     
  •  NOTHING NEW  As of 2020, the efficacy of andexanet alfa has not been demonstrated using clinical endpoints. Further evaluation is needed, with the aim of providing comparative data based on clinical criteria. When bleeding occurs in a patient receiving a xaban, the key action is to put in place proven emergency supportive measures.

©Prescrire 1 July 2020

Source: "Andexanet alfa (Ondexxya°) as an antidote to xabans. Inadequate clinical evaluation" Prescrire International 2020; 29 (217): 173-176. Subscribers only.

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