TY - JOUR
T1 - Three-Year-Follow-Up of the NOTION-2 Trial
T2 - TAVR Versus SAVR to Treat Younger Low-Risk Patients with Tricuspid or Bicuspid Aortic Stenosis
AU - Jørgensen, Troels Højsgaard
AU - Savontaus, Mikko
AU - Willemen, Yannick
AU - Bleie, Øyvind
AU - Tang, Mariann
AU - Angerås, Oskar
AU - Niemela, Matti
AU - Gudmundsdóttir, Ingibjörg J
AU - Khokhar, Arif
AU - Sartipy, Ulrik
AU - Dagnegård, 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 - Prendergast, Bernard
AU - Sondergaard, Lars
AU - Hørsted Thyregod, Hans Gustav
AU - De Backer, Ole
AU - NOTION-2 investigators
PY - 2025/11/11
Y1 - 2025/11/11
N2 - 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.
AB - 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.
KW - aortic stenosis
KW - low surgical risk
KW - surgical aortic valve replacement
KW - transcatheter aortic valve replacement
KW - younger patients
U2 - 10.1161/CIRCULATIONAHA.125.076678
DO - 10.1161/CIRCULATIONAHA.125.076678
M3 - Journal article
C2 - 40884768
SN - 0009-7322
VL - 152
SP - 1326
EP - 1337
JO - Circulation
JF - Circulation
IS - 19
ER -