Heart failure & cardiomyopathiesSecondary analysis

Effect of Vutrisiran According to Baseline Tafamidis Use in Transthyretin Amyloidosis With Cardiomyopathy

J Am Coll CardiolPublished

  • Secondary analysis of the HELIOS-B randomised trial
  • subgroup analysis by baseline tafamidis use
  • tafamidis use stratified

Authors' conclusion

Treatment effect estimates for vutrisiran on clinical outcomes were consistent across baseline tafamidis strata, with no statistically significant interaction according to baseline tafamidis use, with reduced effect size noted in those receiving baseline stabilizers in comparison to monotherapy.

Study context

Population
Patients with ATTR-CM (transthyretin amyloidosis with cardiomyopathy), by baseline tafamidis use259 (40%) on tafamidis
Participants
654 patients
Comparison
Vutrisiran vs placebo, by baseline tafamidis use
Primary endpoint
All-cause mortality and recurrent CV events

Primary result

As reported in the abstract

All-cause mortality and recurrent CV events, by baseline tafamidis use
Vutrisiran vs PlaceboRate ratio (95% CI)
with tafamidis
0.79(0.51–1.21)
without tafamidis
0.67(0.49–0.93)

Secondary outcomes

All-cause mortality, CV events, outpatient worsening HF, by baseline tafamidis use

Similar patterns; effects numerically smaller with tafamidis
  • all interaction P > 0.20

6-minute walk distance, by baseline tafamidis use

Vutrisiran preserved 6-minute walk distance in both strata
  • interaction P = 0.24

KCCQ-OSS, by baseline tafamidis use

Improvement appeared attenuated with baseline tafamidis

Original publication

Effect of Vutrisiran According to Baseline Tafamidis Use in Transthyretin Amyloidosis With Cardiomyopathy. J Am Coll Cardiol. Published 30 August 2026. doi:10.1016/j.jacc.2026.07.022

Summarised from the published abstract; every number is checked against it