TAVR UNLOAD Trial—Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis—Coverage of TCT 2024 | SCAI

Why is this study important? 

  • Studies have shown an association between moderate aortic stenosis (AS) and increased mortality, particularly in patients with heart failure with reduced ejection fraction (HFrEF). 
  • Management of these patients with regard to potential benefits from earlier interventions presents a clinical conundrum. 

What question was this study supposed to answer? 

  • TAVR UNLOAD trial aimed to compare transcatheter aortic valve replacement (TAVR) to guideline-directed medical therapy (GDMT) in patients with HFrEF and moderate AS. 

What did the study show? 

  • 178 patients with HFrEF (EF 20-50%) and moderate AS were randomized to a strategy of transfemoral TAVR with balloon-expandable Sapien valve or optimal GDMT. 
  • Mean age was 76 years, 21% were females and mean left ventricular EF was 39%.  
  • At median follow-up of 23 months, early TAVR failed to show improvement in primary endpoint of all-cause death, disabling stroke, disease-related hospitalizations and heart failure equivalents, and change from baseline in the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score when compared to GDMT alone.  
  • At 12-months follow up, there was improvement in KCCQ-OS score in the TAVR arm as compared with GDMT arm.  

Key takeaways 

  • Early intervention with TAVR did not provide benefit with respect to mortality when compared to GDMT. 
  • There may be a quality-of-life benefit with early TAVR compared to GDMT in this cohort. 

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