Arrhythmias & electrophysiology

Edoxaban Dose Adjustment and Age-Associated Outcomes in Patients With Atrial Fibrillation Post-Transcatheter Aortic Valve Replacement

JACC AdvPublished Secondary analysis of the ENVISAGE-TAVI atrial fibrillation (AF) randomised trial

Primary result · Clinical outcomes by eDAC, age and treatmentResult — go to the resultHazard ratio 1.73 95% CI 1.01–2.95

Authors' conclusion

Patients aged ≥80 years without eDAC were at a higher risk of major bleeding and MGIB events with edoxaban 60 mg vs VKA.

Study context

Population
Patients with AF after transcatheter aortic valve replacement (TAVR)
Participants
1,377 patients
Comparison
Patients with vs without edoxaban dose adjustment criteria (eDAC), by age and treatment
  • eDACn = 637
  • No eDACn = 740reference
Methodological detailson-treatment analysis
  • On-treatment analysis

Primary result

Clinical outcomes by eDAC, age and treatment

Hazard ratio

1.73

95% CI 1.01–2.95

P = 0.045

eDACvs No eDAC
HR 1.73 (95% CI 1.01–2.95); P = 0.045

As reported in the abstract

Safety

OutcomeHR (95% CI)
Major bleeding, age ≥80 years without eDAC (annualized)Edoxabanvs VKA1.86 (1.04–3.32)
Major GI bleeding, age ≥80 years without eDAC (annualized)Edoxabanvs VKA3.79 (1.56–9.25)
OutcomeeDACNo eDAC
Major GI bleeding in edoxaban-treated patients4.65%/year8.03%/year
Major GI bleeding, age <80 years2.98%/year4.22%/year

Original publication

Edoxaban Dose Adjustment and Age-Associated Outcomes in Patients With Atrial Fibrillation Post-Transcatheter Aortic Valve Replacement. JACC Adv. Published 19 November 2025. doi:10.1016/j.jacadv.2025.102329

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