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Randomized Controlled Trial
. 2024 Oct 5;45(37):3804-3814.
doi: 10.1093/eurheartj/ehae331.

Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial

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

Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial

Troels Højsgaard Jørgensen et al. Eur Heart J. .

Abstract

Background and aims: Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤75 years of age, including both tricuspid and bicuspid AS.

Methods: The Nordic Aortic Valve Intervention (NOTION)-2 trial enrolled and 1:1 randomized low-risk patients aged ≤75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke, or rehospitalization (related to the procedure, valve, or heart failure) at 12 months.

Results: A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group [absolute risk difference 3.1%; 95% confidence interval (CI), -2.7% to 8.8%; hazard ratio (HR) 1.4; 95% CI, 0.7-2.9; P = .3]. Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation, and moderate or greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0; 95% CI, 0.5-2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8; 95% CI, 0.8-18.5) treated with TAVI or surgery, respectively (P for interaction = .1).

Conclusions: Among low-risk patients aged ≤75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at 1 year was similar between TAVI and surgery. Transcatheter aortic valve implantation outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134).

Trial registration number: ClinicalTrials.gov NCT02825134.

Keywords: Aortic valve stenosis; Bicuspid and tricuspid aortic valve; Surgical aortic valve replacement; Transcatheter aortic valve implantation.

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