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, Mikko Savontaus, Yannick Willemen, Øyvind Bleie, Mariann Tang, Oskar Angerås, Matti Niemelä, Ingibjörg Jóna Guðmundsdóttir, Arif Khokhar, Ulrik Sartipy, Hanna Dagnegård, Mika Laine, Andreas Rück, Jarkko Piuhola, Pétur Pétursson, Evald Høj Christiansen, Markus Malmberg, Peter Skov Olsen, Rune Haaverstad, Bernard Prendergast, Lars Søndergaard, Hans Gustav Hørsted Thyregod, Ole De Backer, for the NOTION-2 Investigators
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.