Andexanet Yields Better Control of Hematoma Expansion Than Usual Care
By Elana Gotkine HealthDay Reporter
FRIDAY, May 17, 2024 -- For patients who had taken factor Xa inhibitors within 15 hours before having an acute intracerebral hemorrhage, andexanet alfa, which reverses the effects of factor Xa inhibitors, results in better control of hematoma expansion than usual care, according to a study published in the May 16/23 issue of the New England Journal of Medicine.
Stuart J. Connolly, M.D., from McMaster University in Hamilton, Ontario, Canada, and colleagues randomly assigned patients who had taken factor Xa inhibitors within 15 hours before having an acute intracerebral hemorrhage to receive andexanet or usual care in a 1:1 ratio (263 and 267 patients, respectively). Efficacy was assessed in an interim analysis involving 452 patients, while safety was assessed in all 530 patients.
The most common indication for factor Xa inhibitors was atrial fibrillation. The researchers found that hemostatic efficacy was achieved in 67.0 and 53.1 percent of 224 and 228 patients receiving andexanet and usual care, respectively (adjusted difference, 13.4 percentage points). The median reduction from baseline to the one- to two-hour nadir in anti-factor Xa activity was 94.5 and 26.9 percent with andexanet and usual care, respectively. Overall, 10.3 and 5.6 percent of patients receiving andexanet and usual care had thrombotic events, respectively; ischemic stroke occurred in 6.5 and 1.5 percent, respectively. No appreciable between-group differences were seen in the modified Rankin scale score or in death within 30 days.
"The reduction in hematoma expansion with andexanet as compared with usual care was accompanied by an increase in thrombotic events, including stroke," the authors write.
The study was funded by Alexion AstraZeneca Rare Disease, AstraZeneca Biopharmaceuticals, and, previously, Portola and Alexion Pharmaceuticals.
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Posted May 2024
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