EuroPCR 2024 | NOTION-2: TAVI vs SAVR, Randomized Study on Low-Risk Young Patients with Severe Tricuspid Disease or Bicuspid Stenosis

Many of the studies comparing TAVR against SAVR in low risk patients included patients between 70-75 years, excluding those with tricuspid valves. 

EuroPCR 2024

This study included low surgical risk patients with severe aortic stenosis and symptoms, 75 years or younger. Participants were randomized 1:1 to receiving TAVR or SAVR, stratified according to sex, need for new revascularization and presence of bicuspid or tricuspid valves. 

Primary end point at one year was a composite of death, stroke, or rehospitalization (procedure, cardiac failure or valve failure related). Secondary end points included death or disabling stroke, major bleeding, new atrial fibrillation, need for pacemaker implantation, aortic valve performance (gradient and paravalvular leak) and functional parameters such as functional class.

370 patients were enrolled, mean age 71.1 years, average STS 1.1, and 26% had bicuspid valves (mainly type 1). Primary end point showed a non-significant difference in events (with higher trend in TAVR) (10.2% vs 7.1%; HR 1.4, CI 95% 0.7-2.9; P=0.3). Neither were there significant differences in death and disabling stroke (3.2% vs 1.6%; HR 2.0, CI 95% 0.5-7.8; P=0.3).

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As regards secondary end points, TAVR patients showed lower bleeding (HR 0.3; P≤0.001), lower incidence of atrial fibrillation (HR 0.1; P≤0.001) and less mismatch (HR 0.5; P=0.02), but showed higher rates of pacemaker implantation (HR 2; P=0.03) and paravalvular leak (P=0.005).

Bicuspid valve patient sub-analysis revealed a significant increase in primary end point incidence (14.3% vs 3.9%; HR 3.8, CI 95% 1.8-18.5; P=0.07). When looking at individual end points, SAVR presented fewer events. 

The authors have concluded that TAVR and SAVR are equivalent in young patients when it comes to the composite event. However, results were less favorable for TAVR in patients with bicuspid valves. 

Dr. Omar Tupayachi

Dr. Omar Tupayachi.
Member of the Editorial Board of

Reference: Presented by Ole De Backer at Late-Breaking Clinical Trials, EuroPCR 2024, May 14-17, Paris, France.

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