Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial

TY - JOUR

T1 - Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis

T2 - 1-Year Results From the All-Comers NOTION Randomized Clinical Trial

AU - Thyregod, Hans Gustav

AU - Steinbrüchel, Daniel Andreas

AU - Ihlemann, Nikolaj

AU - Nissen, Henrik

AU - Kjeldsen, Bo Juel

AU - Petursson, Petur

AU - Chang, Yanping

AU - Franzen, Olaf Walter

AU - Engstrøm, Thomas

AU - Clemmensen, Peter

AU - Hansen, Peter Bo

AU - Andersen, Lars Willy

AU - Olsen, Peter Skov

AU - Søndergaard, Lars

N1 - Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PY - 2015/5/26

Y1 - 2015/5/26

N2 - 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.

AB - 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.

KW - Aged

KW - Aortic Valve

KW - Aortic Valve Stenosis

KW - Female

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation

KW - Humans

KW - Male

KW - Severity of Illness Index

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement

KW - Treatment Outcome

U2 - 10.1016/j.jacc.2015.03.014

DO - 10.1016/j.jacc.2015.03.014

M3 - Journal article

C2 - 25787196

SN - 0735-1097

VL - 65

SP - 2184

EP - 2194

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 20

ER -