Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial

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, Peter Skov Olsen, Hans Gustav Hørsted Thyregod
Circulation. Cardiovascular Interventions 2016, 9 (6)

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: Unique identifier: NCT01057173.

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