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EuroPCR 2024 Highlights

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TAVI vs. Surgery in Low-Risk Patients with Severe Aortic Stenosis: Insights from the NOTION-2 Trial

20 May 2024

Transcatheter aortic valve implantation (TAVI) has emerged as the preferred treatment for older patients with severe symptomatic aortic stenosis (AS). This year at EuroPCR 2024, investigators presented results from the NOTION-2 trial, whereby they compared TAVI with surgical aortic valve replacement (SAVR) in low-risk patients aged 75 or younger, including those with both tricuspid and bicuspid AS. Results from the study were also published in the European Heart Journal.

The NOTION-2 trial enrolled low-risk patients aged 75 years or younger with severe symptomatic AS, randomly assigning them to receive either TAVI or SAVR. The primary endpoint was a composite measure of all-cause mortality, stroke, or rehospitalization (related to the procedure, valve, or heart failure) at 12 months.

A total of 370 patients with an average age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1% participated in the study, including 100 patients with bicuspid AS. At the 1-year mark, the primary endpoint incidence was 10.2% in the TAVI group compared to 7.1% in the surgery group (absolute risk difference of 3.1%; 95% confidence interval [CI], −2.7% to 8.8%; hazard ratio (HR) 1.4, 95% CI: 0.7 to 2.9; p=0.3).

Patients undergoing TAVI had a lower risk of major bleeding and new-onset atrial fibrillation but a higher risk of non-disabling stroke, permanent pacemaker implantation, and moderate-or-greater paravalvular regurgitation compared to those undergoing surgery. The primary composite endpoint risk was 8.7% in TAVI and 8.3% in SAVR for tricuspid AS patients (HR 1.0, 95% CI: 0.5 to 2.3) and 14.3% in TAVI versus 3.9% in SAVR for bicuspid AS patients (HR 3.8, 95% CI: 0.8 to 18.5) (P for interaction=0.1).

The investigators concluded that for low-risk patients aged 75 years or younger with severe symptomatic AS, the 1-year composite rate of death, stroke, or rehospitalization was similar between TAVI and SAVR. However, outcomes for young patients with bicuspid AS treated with TAVI suggest the need for further investigation.

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Original article: Jørgensen TH, et al. Eur Heart J. 2024.


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