Andexanet Alfa Reduces Hematoma Expansion in Intracerebral Hemorrhage Patients Receiving Factor Xa Inhibitors: NEJM

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Researchers have investigated the efficacy and safety of andexanet alfa, a reversal agent for factor Xa inhibitors, in patients with acute intracerebral hemorrhage. Hematoma expansion is a significant concern in these patients, particularly those on anticoagulant therapy. Patients with acute intracerebral hemorrhage who are receiving factor Xa inhibitors are at risk of hematoma expansion, which can lead to worse outcomes. Andexanet alfa has been proposed as a reversal agent for factor Xa inhibitors, but its efficacy and safety in this population have not been well studied.

This study was published in The New England Journal Of Medicine by Stuart J. and colleagues. In this randomized controlled trial, patients with acute intracerebral hemorrhage within 15 hours of taking factor Xa inhibitors were assigned to receive either andexanet or usual care. The primary endpoint was hemostatic efficacy, defined by limited hematoma volume expansion, improvement in neurologic deficit, and no receipt of rescue therapy between 3 and 12 hours after treatment initiation. Safety endpoints included thrombotic events and death.

The key findings of the study were as follows:

  • A total of 530 patients with acute intracerebral hemorrhage and recent use of factor Xa inhibitors were enrolled in the study, with 263 assigned to receive andexanet and 267 to receive usual care.

  • Hemostatic efficacy, defined by limited hematoma volume expansion, was achieved in 67.0% of patients receiving andexanet alfa, compared to 53.1% of patients receiving usual care.

  • No significant differences were observed between the groups in terms of functional outcomes or mortality within 30 days.

  • Thrombotic events occurred in 10.3% of patients receiving andexanet and 5.6% receiving usual care, with ischemic stroke occurring in 6.5% and 1.5% of patients, respectively.

The study demonstrates that andexanet alfa improves control of hematoma expansion in patients with intracerebral hemorrhage who are receiving factor Xa inhibitors. However, its use is associated with an increased risk of thrombotic events, including ischemic stroke.

Andexanet alfa shows promise in reducing hematoma expansion in patients with intracerebral hemorrhage on factor Xa inhibitors, but its use must be carefully balanced with the risk of thrombotic events. Further research is needed to optimize its safety and efficacy profile in this population.

Reference:

Connolly, S. J., Sharma, M., Cohen, A. T., Demchuk, A. M., Członkowska, A., Lindgren, A. G., Molina, C. A., Bereczki, D., Toni, D., Seiffge, D. J., Tanne, D., Sandset, E. C., Tsivgoulis, G., Christensen, H., Beyer-Westendorf, J., Coutinho, J. M., Crowther, M., Verhamme, P., Amarenco, P., … Shoamanesh, A. (2024). Andexanet for factor xa inhibitor–associated acute intracerebral hemorrhage. The New England Journal of Medicine, 390(19), 1745–1755. https://doi.org/10.1056/nejmoa2313040




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