In patients with intracerebral hemorrhage (ICH) who are taking factor Xa inhibitor anticoagulants, andexanet alfa (Andexxa/Ondexxya, AstraZeneca) rapidly reduced antifactor Xa (anti-Xa) activity and increased the rate of hemostatic efficacy, but was also associated with an increase in thrombotic events in the ANNEXa-I study.
"Andexanet can be considered for patients with ICH associated with factor Xa inhibitors but, as with many treatments, we will need to balance the benefits and risks and use careful risk stratification for patient selection," lead investigator of the study, Stuart Connolly, MD, professor of medicine, McMaster University, Hamilton, Ontario, Canada, concluded.
Connolly presented the ANNEXa-I study at the recent World Stroke Congress (WSC) 2023 held in Toronto, Canada.
Andexanet, which is conditionally approved in Canada, the US, and Europe, is specifically designed to rapidly reverse the anticoagulation effects of direct oral factor-Xa inhibitors, such as apixaban, rivaroxaban, and edoxaban, due to life-threatening or uncontrolled bleeding.
In a previous nonrandomized open-label study (ANNEXA-4) in patients with acute major bleeding linked to the use of factor Xa inhibitors, the agent was associated with a 92% reduction from baseline in anti-Xa activity, with 82% of patients showing excellent or good clinical hemostasis 12 hours after andexanet infusion.
