Arrhythmias & electrophysiology

Abelacimab vs Rivaroxaban in Older Individuals With Atrial Fibrillation: A Prespecified Analysis of the Phase 2b AZALEA-TIMI 71 Trial

JAMA CardiolPublished Secondary analysis of the AZALEA-TIMI 71 randomised trial

Authors' conclusion

This study found that abelacimab consistently reduced bleeding compared with rivaroxaban regardless of age, with the potential for a greater absolute reduction in bleeding with older age.

Study context

Population
Patients with atrial fibrillation (AF), analysed by age (<75 vs ≥75 years)625 (49%) ≥75 years
Participants
1,287 patients
Comparison
Abelacimab vs rivaroxaban, by age
Primary endpoint
Composite of:
  • Major
  • Clinically relevant nonmajor (CRNM) bleeding
Methodological detailsprespecified analysis, phase 2b, Trial conducted March 2021 to September 2023; analysis February to May 2025
  • Prespecified analysis
  • Phase 2b
  • Trial conducted March 2021 to September 2023; analysis February to May 2025

Primary result

As reported in the abstract

Major or CRNM bleeding, by age
Each group vs rivaroxabanHazard ratio (95% CI)
Abelacimab 90 mgage ≥75 years
0.32(0.17–0.60)
Abelacimab 150 mgage ≥75 years
0.40(0.22–0.73)
Abelacimab 90 mgage <75 years
0.28(0.12–0.61)
Abelacimab 150 mgage <75 years
0.35(0.17–0.70)
Absolute risk reduction vs rivaroxaban, age ≥75 years (abelacimab 90 and 150 mg)
7.1 and 6.2 per 100 patient-years
Absolute risk reduction vs rivaroxaban, age <75 years (abelacimab 90 and 150 mg)
4.7 and 4.2 per 100 patient-years
Age modeled continuously: bleeding risk tended to increase with age with rivaroxaban but remained stable with abelacimab
P for interaction, .33

Further findings

Bleeding risk with age modeled continuously

Bleeding risk tended to increase with age with rivaroxaban but remained stable with abelacimab
  • P for interaction, .33

Original publication

Abelacimab vs Rivaroxaban in Older Individuals With Atrial Fibrillation: A Prespecified Analysis of the Phase 2b AZALEA-TIMI 71 Trial. JAMA Cardiol. Published 1 March 2026. doi:10.1001/jamacardio.2025.5418

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