Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis

• Published in: Journal of the American College of Cardiology 2015-05, Vol.65 (20), p.2184-2194
• Main Authors: Thyregod, Hans Gustav Hørsted, MD, Steinbrüchel, Daniel Andreas, MD, DMSc, Ihlemann, Nikolaj, MD, PhD, Nissen, Henrik, MD, PhD, Kjeldsen, Bo Juel, MD, PhD, Petursson, Petur, MD, Chang, Yanping, MS, Franzen, Olaf Walter, MD, Engstrøm, Thomas, MD, DMSc, Clemmensen, Peter, MD, DMSc, Hansen, Peter Bo, MD, Andersen, Lars Willy, MD, DMSc, Olsen, Peter Skov, MD, DMSc, Søndergaard, Lars, MD, DMSc
• Format: Article
• Language: English
• Subjects: aortic valve prosthesis; Cardiology; Cardiovascular; Cardiovascular disease; Clinical outcomes; Heart attacks; Internal Medicine; Medical imaging; Medical prognosis; Mortality; myocardial infarction; Prostheses; Stroke; Surgery; Surgical outcomes; Ultrasonic imaging; Values
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2015.03.014

Abstract Background Transcatheter aortic valve replacement (TAVR) is an option in certain high-risk surgical patients with severe aortic valve stenosis. It is unknown whether TAVR can be safely introduced to lower-risk patients. Objectives The NOTION (Nordic Aortic Valve Intervention Trial) randomized clinical trial compared TAVR with surgical aortic valve replacement (SAVR) in an all-comers patient cohort. Methods Patients ≥70 years old with severe aortic valve stenosis and no significant coronary artery disease were randomized 1:1 to TAVR using a self-expanding bioprosthesis versus SAVR. The primary outcome was the composite rate of death from any cause, stroke, or myocardial infarction (MI) at 1 year. Results A total of 280 patients were randomized at 3 Nordic centers. Mean age was 79.1 years, and 81.8% were considered low-risk patients. In the intention-to-treat population, no significant difference in the primary endpoint was found (13.1% vs. 16.3%; p = 0.43 for superiority). The result did not change in the as-treated population. No difference in the rate of cardiovascular death or prosthesis reintervention was found. Compared with SAVR-treated patients, TAVR-treated patients had more conduction abnormalities requiring pacemaker implantation, larger improvement in effective orifice area, more total aortic valve regurgitation, and higher New York Heart Association functional class at 1 year. SAVR-treated patients had more major or life-threatening bleeding, cardiogenic shock, acute kidney injury (stage II or III), and new-onset or worsening atrial fibrillation at 30 days than did TAVR-treated patients. Conclusions In the NOTION trial, no significant difference between TAVR and SAVR was found for the composite rate of death from any cause, stroke, or MI after 1 year. (Nordic Aortic Valve Intervention Trial [NOTION]; NCT01057173 )