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

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.