Heart failure & cardiomyopathiesSecondary analysis
Vutrisiran Improves Survival and Reduces Cardiovascular Events in ATTR Amyloid Cardiomyopathy
- Secondary analysis of the HELIOS-B randomised trial
- double-blind
- placebo-controlled
- open-label extension
- prespecified mortality analyses
Authors' conclusion
Consistent with the primary trial results, vutrisiran reliably reduced the risk of ACM, CV mortality, CV hospitalizations, HF hospitalizations, and urgent HF visits vs placebo in patients with ATTR-CM.
Study context
- Population
- Patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM)
- Participants
- 655 patients
- Comparison
- Vutrisiran vs placebo
- Primary endpoint
- All-cause mortality and cardiovascular (CV) mortality
- Follow-up
- 39 to 42 months
Primary result
As reported in the abstract
39 to 42 months
Vutrisiran vs PlaceboHazard ratio (95% CI)
all-cause mortality
0.64(0.46–0.88)
CV mortality
0.67(0.47–0.96)
Further findings
| Outcome | Estimate | |
|---|---|---|
| Composite of CV mortality and CV events | HR 0.72 (95% CI 0.55–0.94) | |
| CV hospitalizations, urgent HF visits, HF hospitalizations · DB period of 33 to 36 months — Vutrisiran vs Placebo · CV hospitalizations | rate ratio 0.75 (95% CI 0.62–0.91) | |
| CV hospitalizations, urgent HF visits, HF hospitalizations · DB period of 33 to 36 months — Vutrisiran vs Placebo · urgent HF visits | rate ratio 0.54 (95% CI 0.30–0.98) | |
| CV hospitalizations, urgent HF visits, HF hospitalizations · DB period of 33 to 36 months — Vutrisiran vs Placebo · HF hospitalizations | rate ratio 0.67 (95% CI 0.52–0.86) | |
| 0.20.5125Ratio (log scale) |
By baseline tafamidis use (subgroup)
- Consistent trends regardless of baseline tafamidis use
Original publication
Vutrisiran Improves Survival and Reduces Cardiovascular Events in ATTR Amyloid Cardiomyopathy. J Am Coll Cardiol. Published 30 April 2025. doi:10.1016/j.jacc.2025.04.008
Summarised from the published abstract; every number is checked against it