THE NOTION-2 trial is a pivotal study that focused on low surgical risk patients aged 75 years or younger, including both tricuspid and bicuspid aortic stenosis (AS) cases. ‘First TAVI vs. SAVR randomised trial in younger low-risk patients with severe tricuspid or bicuspid aortic valve stenosis – results from NOTION-2’ was presented by Ole De Backer, Copenhagen University Hospital Rigshospitaletin, Denmark at a press conference at EuroPCR 2024 held in Paris, France on Tuesday 14th May 2025.
Transcatheter aortic valve implantation (TAVI) stands at the forefront of therapeutic options for addressing severe symptomatic AS in older patients. Yet, the landscape is evolving, with a notable trend toward adopting TAVI as the preferred choice, even for younger, low-risk patients. This shift, particularly pronounced in the USA, prompts a closer examination of its efficacy and safety, especially in comparison to surgical aortic valve replacement (SAVR).
The trial’s first significant finding demonstrated a clinical balance between TAVI and surgery concerning the primary composite endpoint of death, stroke, or rehospitalisation at 1 year. However, secondary endpoint analyses demonstrated that TAVI was associated with a higher incidence of non-disabling stroke, moderate or severe paravalvular regurgitation (PVR), and new permanent pacemaker implantation. Conversely, there was a lower occurrence of new-onset atrial fibrillation and major bleeding compared to surgery. The disparity in non-disabling stroke and PVR predominantly surfaced within the bicuspid AS cohort.
The trial highlighted that TAVI recipients experienced faster improvement in dyspnoea symptoms and quality of life, emphasising its potential benefits.
The NOTION-2 trial offers a pivotal perspective on TAVI’s role in managing severe AS among low-risk patients aged 75 years or younger. These findings provide guidance to interventional cardiologists navigating treatment decisions in this landscape.
Reference:
Oler De Backer et al. First TAVI vs. SAVR randomised trial in younger low-risk patients with severe tricuspid or bicuspid aortic valve stenosis – results from NOTION-2 trial. EuroPCR 15.05.2024
