ANNEXA-4: Andexanet Shows Promise For Rapid Reverse of Xa Inhibitors
The use of andexanet alfa (andexanet) in patients with acute major bleeding following an Xa inhibitor may “rapidly reverse anti-factor Xa activity,” according to preliminary results from the ANNEXA-4 trial presented Aug. 30 during ESC Congress 2016 in Rome and simultaneously published in the New England Journal of Medicine.
The study, led by Stuart J. Connolly, MD, FACC, et al., looked at 67 patients with acute major bleeding within 18 hours after the administration of a factor Xa inhibitor: apixaban, rivaroxaban, edoxaban or enoxaparin. The mean age was 77 years and all patients had a history of thrombotic events and cardiovascular disease. Primary sites of bleeding were gastrointestinal (49 percent) and intracranial (42 percent). Patients received an initial bolus of andexanet followed by a two-hour infusion of the drug. Dosing was based on which factor Xa (fXa) inhibitor they had been exposed to, and when. Patients were assessed at baseline, end-of-bolus, and end of the two-hour infusion, as well as at four, eight and 12 hours, and three and 30 days post-infusion.
According to the study authors, further analysis of the data following additional enrollment “should provide details regarding the relationship between the reduction in anti-factor Xa activity and clinical hemostatic outcomes.” They suggest that “a controlled study would be required to assess whether the frequency of these events exceeded that expected in patients at increased risk for thrombotic events.”
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