Arrhythmias & electrophysiologySecondary analysis
Safety of Factor XI Inhibition With Abelacimab in Atrial Fibrillation by Kidney Function
- Secondary analysis of the AZALEA-TIMI 71 randomised trial
- stratified by creatinine clearance
Authors' conclusion
In this secondary analysis of the AZALEA-TIMI 71 randomized clinical trial, abelacimab consistently reduced the risk of bleeding relative to rivaroxaban irrespective of kidney function.
Study context
- Population
- Patients with atrial fibrillation (AF), excluding creatinine clearance (CrCl) <15 mL/min or dialysis264 with CrCl ≤50 mL/min
- Participants
- 1,284 patients
- Comparison
- Abelacimab vs rivaroxaban, by kidney function
- Primary endpoint
- Major or CRNM bleeding
Primary result
As reported in the abstract
Major or CRNM bleeding, by CrCl
Abelacimab vs RivaroxabanHazard ratio (95% CI)
CrCl ≤50 mL/min
0.26(0.12–0.54)
CrCl >50 mL/min
0.40(0.26–0.62)
Absolute risk reduction, per 100 person-years
- CrCl ≤50 mL/min
- 10.1
- CrCl >50 mL/min
- 4.2
Further findings
Major or Clinically Relevant Nonmajor (CRNM) bleeding in Rivaroxaban, CrCl ≤50 vs >50 mL/min
per 100 person-years
- Incidence rate, CrCl ≤50 mL/min (despite dose reduction)
- 13.6
- Incidence rate, CrCl >50 mL/min
- 7.0
Major bleeding alone; major, CRNM and minor bleeding; individual abelacimab doses
- Risk reduction consistent for major bleeding alone and broader composite; similar for each abelacimab dose vs rivaroxaban
Original publication
Safety of Factor XI Inhibition With Abelacimab in Atrial Fibrillation by Kidney Function. JAMA Cardiol. Published 1 November 2025. doi:10.1001/jamacardio.2025.3393
Summarised from the published abstract; every number is checked against it