Valvular & structural heart disease

Sex Differences Among Patients Receiving Edoxaban vs Vitamin K Antagonist for Atrial Fibrillation After TAVR

JACC AdvPublished Secondary analysis of the ENVISAGE-TAVI AF randomised trial

Authors' conclusion

Edoxaban compared to VKA was associated with a similar risk of NACE and higher risk of major bleeding in both sexes. The increase in bleeding complications with edoxaban was attenuated in women.

Study context

Population
Patients with AF after successful TAVR658 (47.8%) women
Participants
1,377 patients
Comparison
Edoxaban vs vitamin K antagonists (VKA), by sex
Primary endpoint
Net adverse CV events (NACE) and major bleeding, on effective time on study medication (safety analysis)
Methodological detailssubgroup analysis by sex
  • Subgroup analysis by sex

Primary result

As reported in the abstract

Edoxaban vs VKAHazard ratio (95% CI)
NACE, women
1.16(0.81–1.65)
NACE, men
1.08(0.76–1.53)
Major bleeding, women
1.11(0.69–1.79)
Major bleeding, men
1.75(1.07–2.85)

Further findings

Ischaemic and major bleeding risks, women vs men

Similar between women and men

Ischaemic complications, by sex

No treatment-related differences in both sexes

Original publication

Sex Differences Among Patients Receiving Edoxaban vs Vitamin K Antagonist for Atrial Fibrillation After TAVR. JACC Adv. Published 8 March 2023. doi:10.1016/j.jacadv.2023.100259

Composed by AI from the published abstract and checked against it. How Briefs are made →

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