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September 10, 2025Circulation27 citationsOpen Access

Three-Year-Follow-Up of the NOTION-2 Trial: TAVR Versus SAVR to Treat Younger Low-Risk Patients with Tricuspid or Bicuspid Aortic Stenosis

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TJTroels Højsgaard JørgensenMSMikko SavontausYWYannick Willemen

Key Points

  • At three years, the primary composite endpoint occurred in 16.1% of TAVR patients compared to 12.6% in surgical patients, indicating comparable outcomes.
  • Bicuspid aortic stenosis patients had a higher risk with TAVR at 20.4% versus 7.8% for surgery, though not statistically significant.
  • Patients aged 60-75 undergoing TAVR had low rates of valve deterioration at 4.5% compared to 5.2% for surgical bioprostheses.
  • Clinical outcomes suggest TAVR is a viable option for younger low-risk patients with severe aortic stenosis.

Abstract

Transcatheter aortic valve replacement (TAVR) is increasingly performed in younger, low surgical risk patients. This NOTION-2 study reports mid-term outcomes in low-risk patients aged 60-75 years with severe tricuspid or bicuspid aortic stenosis (AS) undergoing TAVR or surgical valve replacement. A total of 370 patients (mean age 71.1 years, mean Society of Thoracic Surgeons Predicted Risk of Mortality STS-PROM 1.2%) were enrolled and randomized 1:1 to TAVR or surgery. This follow-up study reports clinical and echocardiographic outcomes up to three years of follow-up. At three years, the primary composite endpoint (death, stroke, or procedure-, valve, or heart failure-related hospitalization) occurred in 16.1% of TAVR patients vs. 12.6% in surgical patients (hazard ratio HR 1.3; 95% confidence interval CI: 0.8 - 2.2%; P=0.4). Among patients with tricuspid AS, rates were similar (14.5% vs. 14.4%), while bicuspid AS patients had a statistical non-significant higher risk with TAVR (20.4% vs. 7.8%; HR 2.9; 95% CI: 0.9 - 9.0). The risk of moderate or greater structural valve deterioration at three years was 4.5% and 5.2% for transcatheter and surgical aortic bioprostheses, respectively (HR 1.2; 95% CI: 0.4-3.1). Bioprosthetic valve failure rates were also comparable: 1.6% in the TAVR and 2.9% in the surgical group. For patients aged 60-75 years with severe AS who are at low surgical risk, three-year clinical outcomes are similar between TAVR and surgery. Both procedures are associated with low rates of structural valve deterioration and need for re-intervention.

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Cite This Study

Jørgensen et al. (2025) studied this question.

synapsesocial.com/papers/68c1dd9b54b1d3bfb60fc3eehttps://doi.org/10.1161/circulationaha.125.076678
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