TY - JOUR
T1 - Transcatheter Aortic Valve Implantation in Low-Risk Tricuspid or Bicuspid Aortic Stenosis
T2 - The NOTION-2 Trial
AU - Jørgensen, Troels Højsgaard
AU - Thyregod, Hans Gustav Hørsted
AU - Savontaus, Mikko
AU - Willemen, Yannick
AU - Bleie, Øyvind
AU - Tang, Mariann
AU - Niemela, Matti
AU - Angerås, Oskar
AU - Gudmundsdóttir, Ingibjörg J
AU - Sartipy, Ulrik
AU - Dagnegaard, Hanna
AU - Laine, Mika
AU - Rück, Andreas
AU - Piuhola, Jarkko
AU - Petursson, Petur
AU - Christiansen, Evald H
AU - Malmberg, Markus
AU - Olsen, Peter Skov
AU - Haaverstad, Rune
AU - Sondergaard, Lars
AU - De Backer, Ole
AU - NOTION-2 investigators
N1 - Publisher Copyright:
© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2024/10/1
Y1 - 2024/10/1
N2 - Background and Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic Aims 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).
AB - Background and Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic Aims 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).
KW - Aortic valve stenosis
KW - Bicuspid and tricuspid aortic valve
KW - Surgical aortic valve replacement
KW - Transcatheter aortic valve implantation
UR - http://www.scopus.com/inward/record.url?scp=85206018171&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehae331
DO - 10.1093/eurheartj/ehae331
M3 - Journal article
C2 - 38747246
SN - 0195-668X
VL - 45
SP - 3804
EP - 3814
JO - European Heart Journal
JF - European Heart Journal
IS - 37
ER -