Three-Year Follow-Up of the NOTION-2 Trial: TAVR Versus SAVR to Treat Younger Low-Risk Patients With Tricuspid or Bicuspid Aortic Stenosis
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.
Article Details
Authors (23)
Troels Højsgaard Jørgensen
Department of Cardiology, Copenhagen University Hospital–Rigshospitalet, Denmark (C.F.Z., J.M.M., R.J., M. Sabbah, C.G., R.S., L.H., G.B., T.H.J., O.D., T.E., J.L.).
Mikko Savontaus
Heart Center, Turku University Hospital, Finland (M. Savontaus).
Yannick Willemen
Department of Cardiology (T.H.J., Y.W., A.K., O.D.B.), Rigshospitalet, Copenhagen University Hospital, Denmark.
Øyvind Bleie
Department of Cardiology, Haukeland University Hospital, Bergen, Norway (Ø.B., R.H.).
Mariann Tang
Department of Cardiology (T.H.J., Y.W., A.K., O.D.B.), Rigshospitalet, Copenhagen University Hospital, Denmark.
Oskar Angerås
Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (D.I., O.A.).
Matti Niemelä
Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Finland (M.N., J.P.).
Ingibjörg J. Gudmundsdóttir
Department of Cardiology, Landspitali, Reykjavík, Iceland (I.J.G.).
Arif Khokhar
Department of Cardiology (T.H.J., Y.W., A.K., O.D.B.), Rigshospitalet, Copenhagen University Hospital, Denmark.
Ulrik Sartipy
Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm
Hanna Dagnegård
Department of Cardiology (T.H.J., Y.W., A.K., O.D.B.), Rigshospitalet, Copenhagen University Hospital, Denmark.
Mika Laine
Andreas Rück
Department of Medicine, Karolinska Institute, Stockholm, Sweden (P.F., R.L., A.R.).
Jarkko Piuhola
Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Finland (M.N., J.P.).
Petur Petursson
Department of Cardiology (T.H.J., Y.W., A.K., O.D.B.), Rigshospitalet, Copenhagen University Hospital, Denmark.
Evald H. Christiansen
Aarhus University Hospital, Aarhus, Denmark
Markus Malmberg
Department of Cardiology (T.H.J., Y.W., A.K., O.D.B.), Rigshospitalet, Copenhagen University Hospital, Denmark.
Peter Skov Olsen
Department of Cardiology (T.H.J., Y.W., A.K., O.D.B.), Rigshospitalet, Copenhagen University Hospital, Denmark.
Rune Haaverstad
Department of Heart Disease, Haukeland University Hospital, Bergen, Norway
Bernard Prendergast
Cleveland Clinic London, London
Lars Sondergaard
Abbott Structural Heart, Santa Clara, CA (L.S.).
Hans Gustav Hørsted Thyregod
Department of Cardiology (T.H.J., Y.W., A.K., O.D.B.), Rigshospitalet, Copenhagen University Hospital, Denmark.
Ole De Backer
From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (D.J.G., W.L.B., J.P., B.J.W.M.R., L.T., M.J.S., J.B., V.J.N., D.C.O., J.M.B.), the Department of Cardiology, Amsterdam UMC, Amsterdam (H.M.A., J.G.P.T., R.D.), the Department of Cardiology, University Medical Center Utrecht, Utrecht (H.M.A., M. Voskuil), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.J.P.R., V.J.N., N.R.), the Department of Cardiology, Maastricht University Medical Center (L.V., A.J.J.I., P.A.V., A.W.J.H.), and Cardiovascular Research Institute Maastricht (L.V., P.A.V., A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Leiden University Medical Center, Leiden (F.K., J.M.M.-C.), the Department of Cardiology, University Medical Center Groningen, Groningen (K.H.B., J.J.W.), the Department of Cardiology, Erasmus University Medical Center, Rotterdam (N.M.V.M.), the Department of Cardiology, Haga Hospital, the Hague (C.E.S.), the Department of Cardiology, Amphia Hospital, Breda (A.J.J.I...