ANNEXA-I: superior hemostatic efficacy with andexanet alfa vs SoC in FXa inhibitor-related ICH

Ashkan Shoamanesh, MD, McMaster University, Population Health Research Institute, Hamilton, ON, Canada, discusses the Phase IV ANNEXa-I trial (NCT03661528): a multicenter study evaluating andexanet alfa in patients with acute intracerebral hemorrhage (ICH) treated with factor Xa inhibitors. The trial aimed to assess the safety and hemostatic efficacy of andexanet alfa versus standard of care (SoC) in patients presenting with acute ICH within six hours of symptom onset. The study, initially designed with a sample of 900 participants, was stopped early in June 2023 due to overwhelming efficacy with andexanet alfa, resulting in a total of 530 participants. Excellent or good hemostatic efficacy outcomes, based on hematoma expansion and NIHSS score changes, were achieved in 63.9% of patients in the andexanet alfa cohort compared with 52.4% in the usual care group. Andexanet alfa also produced a substantial reduction in median FXa inhibitor activity (94.4% vs 23.5% in the usual care arm). However, excess thrombotic events at 30 days were observed with andexanet alfa, particularly ischemic strokes. Dr Shoamanesh emphasizes the study's limitation in power to detect differences in mortality and long-term outcomes and highlights the need for further research to assess the long-term effects of acute interventions in patients with acute ICH. This interview occurred during the International Stroke Conference 2024 in Phoenix, AZ.
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