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Abelacimab substantially lowers bleeding risk compared with rivaroxaban

Presented by
Dr Christian Ruff, Brigham and Women’s Hospital, USA
AHA 2023
Phase 3, AZALEA-TIMI 71
In the phase 3 AZALEA-TIMI 71 trial, abelacimab significantly reduced bleeding events compared with rivaroxaban in patients with atrial fibrillation (AF). Furthermore, the agent showed potent inhibition of factor XI. Whether this novel agent also reduces the risk of ischaemic events compared to other anticoagulants requires further study.

The multicentre, randomised, active-controlled AZALEA-TIMI 71 trial (NCT04755283) compared the bleeding profile of the factor XI inhibitor abelacimab with the DOAC rivaroxaban in patients with AF and a moderate-to-high risk of stroke. The participants (n=1,287) were randomised in a 1:1:1 fashion to receive 90 mg or 150 mg abelacimab, subcutaneously administered, once per month, or 20 mg rivaroxaban, orally administered, once daily. The primary endpoint was major or clinically relevant non-major (CRNM) bleeding. Dr Christian Ruff (Brigham and Women’s Hospital, MA, USA) presented the key findings.

“The trial was terminated early because the data monitoring committee reported that abelacimab yielded a larger than anticipated reduction in the primary endpoint compared with the active comparator,” announced Dr Ruff. At the time of termination of the trial, abelacimab displayed a factor XI inhibition >95% in both dose groups. Further, the occurrence of major or CRNM bleeding was significantly lower in the 90 mg group (HR 0.23; 95% CI 0.13–0.42; P<0.0001) and the 150 mg group (HR 0.33; 95% CI 0.19–0.55; P<0.0001) than in the rivaroxaban group.

No significant difference was observed in the risk of stroke or systemic embolism between the rivaroxaban group and either the 90 mg abelacimab group (HR 1.13; 95% CI 0.41–3.12; P=0.81) or the 150 mg group (HR 1.45; 95% CI 0.55–3.80; P=0.45). “However, the rates of these events were low and were only evaluated as exploratory endpoints,” commented Dr Ruff. Finally, there were no substantial differences between the safety profiles of the 2 agents.

    1. Ruff CT, et al. A multicentre randomised active-controlled study to evaluate the safety and tolerability of two blinded doses of abelacimab compared with open-label rivaroxaban in patients with atrial fibrillation. LB05, AHA Scientific Sessions 2023, 10–12 November, Philadelphia, USA.


Medical writing support was provided by Robert van den Heuvel.
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