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Randomized Controlled Trial
. 2025 Nov 11;152(19):1326-1337.
doi: 10.1161/CIRCULATIONAHA.125.076678. Epub 2025 Aug 30.

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

Troels Højsgaard Jørgensen  1 , Mikko Savontaus  1 , Yannick Willemen  1 , Øyvind Bleie  2 , Mariann Tang  1 , Oskar Angerås  1 , Matti Niemela  3 , Ingibjörg J Gudmundsdóttir  4 , Arif Khokhar  1 , Ulrik Sartipy  5 , Hanna Dagnegård  1   6 , Mika Laine  7 , Andreas Rück  8 , Jarkko Piuhola  3 , Petur Petursson  1 , Evald H Christiansen  1 , Markus Malmberg  1 , Peter Skov Olsen  1 , Rune Haaverstad  1 , Bernard Prendergast  9 , Lars Sondergaard  10 , Hans Gustav Hørsted Thyregod  1 , Ole De Backer  1 ; NOTION-2 Investigators
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Free article
Randomized Controlled Trial

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

Troels Højsgaard Jørgensen et al. Circulation. .
Free article

Abstract

Background: Transcatheter aortic valve replacement (TAVR) is increasingly performed in younger, low surgical risk patients. The NOTION-2 study (The Nordic Aortic Valve Intervention) reports midterm outcomes in low-risk patients age 60 to 75 years with severe tricuspid or bicuspid aortic stenosis 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, 1.2%) were enrolled and randomized 1:1 to TAVR or surgery. This follow-up study reports clinical and echocardiographic outcomes up to 3 years of follow-up.

Results: At 3 years, the primary composite end point (death, stroke, or procedure-, valve-, or heart failure-related hospitalization) occurred in 16.1% of patients with TAVR versus 12.6% in surgical patients (hazard ratio, 1.3; 95% CI, 0.8-2.2%; I=0.4). Among patients with tricuspid aortic stenosis, rates were similar (14.5% versus 14.4%), whereas patients with bicuspid aortic stenosis had a statistically nonsignificant higher risk with TAVR (20.4% versus 7.8%; hazard ratio, 2.9; 95% CI, 0.9-9.0). The risk of moderate or greater structural valve deterioration at 3 years was 4.5% and 5.2% for transcatheter and surgical aortic bioprostheses, respectively (hazard ratio, 1.2; 95% CI, 0.4-3.1). Bioprosthetic valve failure rates were also comparable: 1.6% in the TAVR group and 2.9% in the surgical group.

Conclusions: For patients age 60 to 75 years with severe aortic stenosis who are at low surgical risk, 3-year clinical outcomes are similar between TAVR and surgery. Both procedures are associated with low rates of structural valve deterioration and need for reintervention.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02825134.

Keywords: aortic stenosis; low surgical risk; surgical aortic valve replacement; transcatheter aortic valve replacement; younger patients.

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Conflict of interest statement

A.K. received speaker fees from Abbott, Boston Scientific, and Medtronic. O.D.B. received institutional research grants and consulting fees from Abbott, Boston Scientific, and Medtronic. M.M. has received congress support from Medtronic, Boston Scientific, and Edwards Lifesciences. A.R. received consulting and research support from Boston Scientific and consulting fees from Abbott, Anteris, and Edwards Lifesciences. B.P. received lecture fees from Edwards Lifesciences and Polares and research consulting fees from Valvosoft. O.A. received a research grant and consulting fees from Abbott and Medtronic and consulting fees from Meril Life.

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