Heart failure & cardiomyopathiesSecondary analysis
Consistent efficacy of vutrisiran across sexes in transthyretin cardiac amyloidosis: evidence from the HELIOS-B trial
- Secondary analysis of the HELIOS-B randomised trial
- prespecified analysis
- phase 3
- double-blind
- placebo-controlled
Authors' conclusion
Women with ATTR-CM demonstrated a distinct baseline phenotype in HELIOS-B. Despite this, vutrisiran showed no statistically detectable heterogeneity of treatment effect by sex within the limits of statistical power
Study context
- Population
- Patients with wild-type or variant transthyretin cardiac amyloidosis (ATTR-CM)49 (7.5%) women
- Participants
- 654 patients
- Comparison
- Vutrisiran vs placebo, by sex
- Primary endpoint
- Composite of:
- All-cause mortality
- Recurrent CV events
Primary result
As reported in the abstract
Primary composite endpoint, by sex (subgroup)
Vutrisiran vs PlaceboHazard ratio (95% CI)
women
0.59(0.26–1.30)
men
0.71(0.54–0.94)
Further findings
All-cause mortality by sex (subgroup) · 42 months
- Mortality reduction, women
- HR 0.56, 95% CI 0.14-2.34
- Mortality reduction, men
- HR 0.65, 95% CI 0.46-0.90
- p-interaction = 0.91
6-minute walk distance and quality-of-life scores by sex (subgroup)
- Decline attenuated in both sexes, with no statistically detectable sex-specific interaction
Original publication
Consistent efficacy of vutrisiran across sexes in transthyretin cardiac amyloidosis: evidence from the HELIOS-B trial. Eur J Heart Fail. Published 26 June 2026. doi:10.1093/ejhf/xuag208
Summarised from the published abstract; every number is checked against it