• Lars Søndergaard, Daniel Andreas Steinbrüchel, Nikolaj Ihlemann, Henrik Nissen, Bo Juel Kjeldsen, Petur Petursson, Anh Thuc Ngo, Niels Thue Olsen, Yanping Chang, Olaf Walter Franzen, Thomas Engstrøm, Peter Clemmensen, Olsen Peter Skov PS From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre,, and Hans Gustav Hørsted Thyregod.
• From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.). Lars.Soendergaard.01@regionh.dk.
• Circ Cardiovasc Interv. 2016 Jun 1; 9 (6).

BackgroundThe Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding bioprosthesis or surgical aortic valve replacement (SAVR), including a lower-risk patient population than previous trials. This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial.Methods And ResultsTwo-hundred eighty patients from 3 centers in Denmark and Sweden were randomized to either TAVR (n=145) or SAVR (n=135) with follow-up planned for 5 years. There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality (6.5% versus 9.1%; P=0.40). The composite outcome of all-cause mortality, stroke, or myocardial infarction was also similar (15.8% versus 18.8%, P=0.43). Forward-flow hemodynamics were improved following both procedures, with effective orifice area significantly more improved after TAVR than SAVR (effective orifice area, 1.7 versus 1.4 cm(2) at 3 months). Mean valve gradients were similar after TAVR and SAVR. When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) (<4% versus ≥4%), there was no statistically significant difference for TAVR and SAVR groups in the composite outcome for low-risk (14.7%, 95% confidence interval, 8.3-21.2 versus 16.8%; 95% confidence interval, 9.7-23.8; P=0.58) or intermediate-risk patients (21.1% versus 27.1%; P=0.59).ConclusionsTwo-year results from the NOTION trial demonstrate the continuing safety and effectiveness of TAVR in lower-risk patients. Longer-term data are needed to verify the durability of this procedure in this patient population.Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01057173.© 2016 American Heart Association, Inc.

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