Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement

Author:

Søndergaard Lars1,Steinbrüchel Daniel Andreas1,Ihlemann Nikolaj1,Nissen Henrik1,Kjeldsen Bo Juel1,Petursson Petur1,Ngo Anh Thuc1,Olsen Niels Thue1,Chang Yanping1,Franzen Olaf Walter1,Engstrøm Thomas1,Clemmensen Peter1,Olsen Peter Skov1,Thyregod Hans Gustav Hørsted1

Affiliation:

1. 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,...

Abstract

Background— The 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 Results— Two-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). Conclusions— Two-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 Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01057173.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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