In this episode, I’ll discuss an article about the reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures.
Andexanet alfa is a reversal agent that competitively binds to factor Xa inhibitors such as apixaban and rivaroxaban. Approval trials like ANNEXA-4 focused on using andexanet alfa to reverse major bleeding associated with factor Xa inhibitors. However another common indication for immediate reversal of factor Xa inhibitors is the emergent need for surgery or an invasive procedure. Such patients have yet to be represented well in studies of andexanet alfa.
A group of authors recently published in the journal Pharmacotherapy a single-center, observational, retrospective study looking at patients who received andexanet alfa within 24 hours of an invasive or surgical procedure. The primary outcome was hemostatic efficacy and grading definitions were similar to those used in the ANNEXA-4 study. There were numerous secondary outcomes evaluated, including hospital discharge disposition, ICU and hospital length of stay, as well as mortality and ischemic event rates.
44 patients were analyzed, about two-thirds of which received apixaban and the rest received rivaroxaban. More than 80% of the patients had an indication for reversal that was either an emergent operative procedure, an invasive device placement, or the need for arterial embolization.
About 80% of the patients achieved excellent or good hemostasis within 24 hours after periprocedural administration of andexanet alfa, and this rate was similar in the apixaban and rivaroxaban groups. About one-third of the patients died by 30 days and about one-quarter had a thromboembolic event.
The authors concluded:
This study demonstrates that andexanet alfa may be used effectively for periprocedural reversal of apixaban and rivaroxaban in patients requiring invasive or surgical intervention.
This is an important publication because it describes andexanet alfa use in a population that was not studied in ANNEXA-4 but is a logical population for the use of andexanet alfa. The favorable results with hemostasis need to be balanced against the one-quarter of patients who had an ischemic or thrombotic event within 30 days of reversal. The clotting events cannot all be attributed to andexanet alfa however, as the majority of patients in this study had their anticoagulation resumed at a lower, prophylactic dose rather than at full therapeutic anticoagulation doses.
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