Abelacimab reduces ischemic Stroke Risk in Atrial Fibrillation Patients with fewer bleeding events: NEJM
Researchers have found in a new research that among patients with atrial fibrillation who are at moderate-to-high risk for stroke, administration of abelacimab at doses of 90 mg or 150 mg led to a sustained and significant reduction in factor XI levels. Additionally, abelacimab treatment resulted in significantly fewer bleeding events compared to rivaroxaban. This study was published in The New England Journal of Medicine by Christian T. and colleagues.
A total of 1,287 patients were recruited into the study, with a median age of 74 years and 44% female. Patients were assigned to three arms: one was treated with abelacimab 150 mg monthly, another with abelacimab 90 mg monthly, and the remaining third arm received rivaroxaban daily. The main endpoint of the study was the rate of major or clinically relevant non major bleeding events. It was administered subcutaneously in two doses of 150 mg and 90 mg of abelacimab compared with oral rivaroxaban at 20 mg/day for safety and efficacy. The study was stopped prematurely because of a significant decrease in bleeding events noted with abelacimab.
Key findings:
Free Factor XI Activity Levels:
• Abelacimab 150 mg resulted in a 99% median reduction in free factor XI activity levels, but the 90-mg dose only reflected a 97% reduction.
Bleeding Safety:
• Abelacimab 150 mg: 3.2 events/100 person-years.
• Abelacimab 90 mg: 2.6 events/100 person-years.
• Rivaroxaban: 8.4 events/100 person-years.
• HR for abelacimab 150 mg compared to rivaroxaban: 0.38 (95% CI, 0.24–0.60; P<0.001).
• HR for abelacimab 90 mg versus rivaroxaban: 0.31 (95% CI, 0.19–0.51; P<0.001).
• Safety Profile: AE was similar across all groups with no difference in the severity.
The marked decrease in bleeding events, observed with abelacimab, underscore its efficacy for lowering free factor XI levels. This is one of the emergent therapeutic targets for anticoagulation, which has created a novel mechanism for stroke prevention with reduced risks of bleeding, which is the most important issue for patients having atrial fibrillation.
Abelacimab lowered the incidence of major or clinically relevant nonmajor bleeding events in comparison with rivaroxaban, in patients with atrial fibrillation. This monoclonal antibody seems a promising advancement in anticoagulation therapy that offers a safer way of preventing stroke.
Reference:
Ruff CT, Patel SM, Giugliano RP, Morrow DA, Hug B, Kuder JF, Goodrich EL, Chen SA, Goodman SG, Joung B, Kiss RG, Spinar J, Wojakowski W, Weitz JI, Murphy SA, Wiviott SD, Parkar S, Bloomfield D, Sabatine MS; AZALEA–TIMI 71 Investigators. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation. N Engl J Med. 2025 Jan 23;392(4):361-371. doi: 10.1056/NEJMoa2406674. PMID: 39842011.
