Heart failure & cardiomyopathies

Outpatient Worsening Heart Failure in Patients With Transthyretin Amyloidosis With Cardiomyopathy in the HELIOS-B Trial

J Am Coll CardiolPublished Secondary analysis of the HELIOS-B randomised trial

Authors' conclusion

Outpatient worsening HF was frequent in patients with ATTR-CM in HELIOS-B, was associated with increased mortality, and reduced by vutrisiran.

Study context

Population
Patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in HELIOS-B
Comparison
Vutrisiran vs placebo; outpatient worsening heart failure (HF) vs none
Primary endpoint
Outpatient worsening HF (oral loop diuretic intensification or initiation): association with composite of all-cause mortality and recurrent CV events, all-cause mortality, and vutrisiran effect
Follow-up
36 months
Methodological detailsdouble-blind
  • Double-blind

Primary result

As reported in the abstract

Outpatient worsening HF: frequency and prognosis
Outpatient worsening HF vs No outpatient worsening HFHazard ratio (95% CI)
All-cause mortality and CV events
2.58(2.04–3.27)
All-cause mortality
2.45(1.70–3.52)
≥1 outpatient worsening HF
321 patients (49.1%)
≥1 cardiovascular (CV) event(s)
245 (37.5%)
Died
120 (18.3%)
No events
237 patients (36.2%)

Further findings

OutcomeEstimate
Rate of outpatient worsening HF (recurrent events) · double-blind periodrelative rate ratio 0.66 (95% CI 0.56–0.78)
Composite of all-cause mortality, CV events and outpatient worsening HFHR 0.69 (95% CI 0.57–0.83)

Original publication

Outpatient Worsening Heart Failure in Patients With Transthyretin Amyloidosis With Cardiomyopathy in the HELIOS-B Trial. J Am Coll Cardiol. Published 18 November 2024. doi:10.1016/j.jacc.2024.11.015

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