Key result
Andexanet alfa rapidly and effectively reversed the anticoagulant effects of apixaban and rivaroxaban, significantly reducing anti-factor Xa activity compared with placebo.
Why the study?
Does andexanet alfa effectively reverse the anticoagulant effects of apixaban and rivaroxaban in adults with acute major bleeding?
Does andexanet alfa effectively reverse the anticoagulant effects of apixaban and rivaroxaban in adults with acute major bleeding?
Absolute Event Rate: -92% vs -33%
p-value: p=<0.001
Andexanet alfa is the first specific reversal agent that rapidly and effectively reverses the anticoagulant effects of apixaban and rivaroxaban in patients with acute major bleeding, though it carries a risk of thromboembolic events.
May support urgent reversal in bleeding; hypothesis-generating and should not yet change practice.
), a first-in-class recombinant modified factor Xa protein, is currently the only specific agent available to reverse life-threatening or uncontrolled bleeding with the factor Xa inhibitors apixaban and rivaroxaban. Andexanet alfa acts as a decoy and competes with endogenous factor Xa to bind factor Xa inhibitors, thereby reversing the anticoagulant effects of factor Xa inhibitors, and restoring the activity of endogenous factor Xa. In adults with major bleeding associated with the use of apixaban or rivaroxaban, intravenous administration of andexanet alfa effectively and rapidly reduces anti-factor Xa levels, with reduced levels being maintained during continued treatment. The tolerability profile of andexanet alfa in patients is generally similar to that reported of other approved anticoagulation reversal agents. With the known increased risk of thromboembolic events following andexanet alfa treatment, anticoagulant therapy should be resumed as soon as medically appropriate.
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Young‐A Heo (2018) conducted a review in Acute major bleeding related to apixaban and rivaroxaban. Andexanet alfa vs. Placebo was evaluated on Mean change in anti-factor Xa activity from baseline to nadir post-infusion (%) for apixaban (ANNEXA-A trial) (p=<0.001). Andexanet alfa rapidly and effectively reversed the anticoagulant effects of apixaban and rivaroxaban, significantly reducing anti-factor Xa activity compared with placebo.
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