AZALEA-TIMI 71 (high-dose abelacimab)
Trial question
What is the role of abelacimab, a human anti-factor XI monoclonal antibody, in patients with AF at moderate-to-high risk of stroke?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 860
860 patients (377 female, 483 male).
Inclusion criteria: patients with AF at moderate-to-high risk of stroke.
Key exclusion criteria: hypersensitivity to study drugs; intracranial or intraocular hemorrhage in the past 3 months; clinically significant MS; mechanical heart valve or other indication for anticoagulation therapy other than AF; active endocarditis; history of LAA closure or removal; presence of an atrial myxoma or LV thrombus.
Interventions
N=430 abelacimab (subcutaneous injection of 150 mg once monthly).
N=430 rivaroxaban (oral dose of 20 mg/day).
Primary outcome
Major or clinically relevant nonmajor bleeding
6.1%
15.4%
15.4 %
11.6 %
7.7 %
3.9 %
0.0 %
Abelacimab
Rivaroxaban
Significant
decrease ▼
NNT = 10
Significant decrease in major or clinically relevant nonmajor bleeding (6.1% vs. 15.4%; HR 0.38, 95% CI 0.24 to 0.6).
Secondary outcomes
Significant decrease in major bleeding (2.3% vs. 7.2%; HR 0.33, 95% CI 0.16 to 0.66).
No significant difference in ICH (0.5% vs. 0.9%; HR 0.51, 95% CI 0.09 to 2.78).
Significant decrease in major, clinically relevant non-major, or minor bleeding (18.3% vs. 26.2%; HR 0.68, 95% CI 0.51 to 0.91).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In patients with AF at moderate-to-high risk of stroke, abelacimab was superior to rivaroxaban with respect to major or clinically relevant nonmajor bleeding.
Reference
Christian T Ruff, Siddharth M Patel, Robert P Giugliano et al. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation. N Engl J Med. 2025 Jan 23;392(4):361-371.
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