The primary endpoint for both trials was the percent change in anti-factor Xa activity, measured via chromogenic assay of enzyme activity. The ANNEXA-A trial and ANNEXA-R trials randomized participants to receive either andexanet or placebo for reversal of apixaban (n = 62), and reversal of rivaroxaban (n = 80) respectively. All participants in both trials were healthy volunteers aged 50-75 and were administered direct factor Xa inhibitors until steady state plasma levels were achieved. In-Depth : The ANNEXA-A and ANNEXA-R trials sought to evaluate the efficacy and safety of andexanet alfa, a recombinant human factor Xa protein, in reversing anticoagulation by the direct factor Xa inhibitors apixaban and rivaroxaban. In summary, the ANNEXA-A and ANNEXA-R trials were among the earliest to demonstrate the efficacy and safety of andaxanet in reversing anticoagulation, and further study could solidify its use as a universal antidote for direct factor Xa inhibitors. Further study regarding the efficacy and safety of andaxanet is needed in these excluded populations. This study is limited by its small sample size and by its population of only healthy volunteers without significant comorbidities or urgent indications for reversal of anticoagulation. Analysis of various biomarkers and measurements of anticoagulation was also very thorough. This study is strengthened by its inclusion of older participants, who are often excluded from such trials, and as a result more closely approximates clinical practice. Furthermore, there were no adverse thrombotic or bleeding events in patients receiving andaxanet, thereby supporting its safety profile. Andaxanet was rapid in onset and offset of action, making it ideal for use when urgent reversal of anticoagulation is required. Study Rundown: The ANNEXA-A and ANNEXA-R trials demonstrated the efficacy of andaxanet alfa as a reversal agent for the direct factor Xa inhibitors apixaban and rivaroxaban. Original Date of Publication: December 2015
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