Andexanet alfa is a recombinant, modified human factor Xa decoy protein developed to reverse the effects of factor Xa inhibitors including enoxaparin, apixaban, and rivaroxaban. RE-VERSE AD established the monoclonal antibody idarucizumab in reversing the anticoagulant effect of the direct thrombin inhibitor dabigatran. While more convenient due to fixed dosing rather than requiring dose adjustments based on INR, the DOACs have been limited by the lack of a highly efficacious method of reversal of their anticoagulant effect. The direct oral anticoagulants (DOACs) including dabigatran, apixaban, and rivaroxaban are safe and effective alternatives to warfarin among patients with thromboembolism and nonvalvular atrial fibrillation, as demonstrated in RE-LY, AMPLIFY, ROCKET AF, and other large trials.
In this single-arm trial, andexanet alfa administration decreased anti-Xa activity and achieved hemostasis in a majority of patients, and was associated with a high rate of thrombosis and death. In adults with potentially life-threatening acute major bleeding, what is the efficacy and safety of andexanet alfa for reversing the anticoagulant effects of the factor Xa inhibitors apixaban, rivaroxaban, edoxaban, or enoxaparin?
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