Event: ESC Heart Failure Congress 2025
Event: ESC Heart Failure Congress 2025
Presenter: Dr. Marianna Fontana (London, UK)
Source: ESC Heart Failure News + J Am Coll Cardiol
1. Background:
• ATTR-CM (transthyretin-mediated amyloid cardiomyopathy) is a life-threatening heart condition caused by abnormal TTR protein deposition in the heart muscle.
• Vutrisiran is a subcutaneous RNAi therapy that inhibits TTR production.
2. Study Design:
• HELIOS-B was a phase 3, double-blind, placebo-controlled, international RCT.
• Included 654 ATTR-CM patients, randomized to:
• Vutrisiran 25 mg SC every 3 months
• Placebo
• Duration: Up to 36 months, followed by an open-label extension (OLE) to 42 months.
• Tafamidis use was permitted before or during the trial.
3. Endpoints Evaluated:
• All-cause mortality and CV death (up to 42 months)
• Recurrent CV events, HF hospitalizations, and urgent HF visits (up to 36 months)
4. Main Results:
1. Mortality Reduction at 42 Months:
• All-cause mortality: HR 0.64 (95% CI: 0.46–0.88; P=0.007)
• CV mortality: HR 0.67 (95% CI: 0.47–0.96; P=0.038)
2. CV Event Reductions at 36 Months:
• Recurrent CV events: RR 0.73 (P<0.001)
• CV hospitalizations: RR 0.75 (P=0.004)
• Urgent HF visits: RR 0.54 (P=0.041)
• HF hospitalizations: RR 0.67 (P=0.002)
3. Subgroup Analyses showed consistent results across age, NYHA class, ATTR type, and NT-proBNP levels.
5. Conclusion:
• Vutrisiran significantly reduced mortality and CV events in patients with ATTR-CM.
• Benefits were observed with or without tafamidis use.
• These findings reinforce the primary results of HELIOS-B and support the use of vutrisiran as a disease-modifying treatment for ATTR-CM.
6. ESC Heart Failure 2025 – The treatment landscape for ATTR-CM is rapidly evolving, with different drugs targeting different aspects of the pathophysiology. Vincenzo Castiglione presents findings from a network meta-analysis, which evaluated the relative efficacy of four disease-modifying treatments for ATTR-CM: tafamidis, acoramidis, patisiran, and vutrisiran.
HELIOS-B Trial – Vutrisiran in ATTR-CM
Simultaneous Publication:
The full study was published concurrently in the Journal of the American College of Cardiology (JACC).
Published: May 22, 2025
JACC – HELIOS-B Publication
https://www.escardio.org/
