Article (Scientific journals)
Rational and design of the ROTAS study: a randomized study for the optimal treatment of symptomatic patients with low-gradient severe aortic valve stenosis and preserved left ventricular ejection fraction.
Galli, Elena; Le Ven, Florent; Coisne, Augustin et al.
2021In European heart journal. Cardiovascular Imaging, 22 (2), p. 229-235
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Keywords :
Aortic Valve/surgery; Aortic Valve Stenosis/diagnostic imaging/surgery; Heart Valve Prosthesis Implantation; Humans; Prognosis; Severity of Illness Index; Stroke Volume; Treatment Outcome; Ventricular Function, Left; aortic stenosis; low gradient; randomized study; stroke volume
Abstract :
[en] AIMS: Fifteen to thirty percentage of patients with severe aortic stenosis (AS) have preserved left ventricular ejection fraction (LVEF) and a discordant AS pattern at Doppler echocardiography, which is characterized by a small (<1 cm2) aortic area and low mean aortic gradient (<40 mmHg). The 'Randomized study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic Stenosis and preserved left ventricular ejection fraction' (ROTAS trial) aims at demonstrating the superiority of aortic valve replacement vs. a 'watchful waiting strategy' in symptomatic patients with low-gradient (LS), severe AS, and preserved LVEF, stratified according to indexed stroke volume, in terms of all-cause mortality or cardiovascular-related hospitalization during follow-up (FU). METHODS AND RESULTS: The ROTAS trial will be a multicentre randomized non-blinded study involving 16 reference centres. AS severity will be confirmed by a multimodality approach (rest and stress echocardiography, calcium scoring, and cardiac magnetic resonance imaging for optimally characterize the population), which could provide important inputs to improve the pathophysiological understanding of this complex disease. Well-characterized patients will be randomized according to the management strategy. The primary endpoint will be the occurrence of all-cause mortality or cardiac related-hospitalizations during 2-year FU. One hundred and eighty subjects per group will be included. CONCLUSION: The management of patients with LS severe AS and preserved LVEF is largely debated. ROTAS trial will allow a comprehensive evaluation of this particular pattern of AS and will establish which is the most appropriate management of these patients.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Galli, Elena;  University of Rennes, CHU Rennes, Inserm, LTSI - UMR 1099, F-35000 Rennes,
Le Ven, Florent;  Service de cardiologie, hôpital Cavale Blanche, CHRU Brest, 29200 Brest, France.
Coisne, Augustin;  Department of Clinical Physiology and Echocardiography, CHU Lille, Heart Valve
Sportouch, Catherine;  Clinique du Millénaire, 34000 Montpellier, France.
Le Tourneau, Thierry;  Department of Cardiology, Thorax Institute, Centre Hospitalier Universitaire de
Bernard, Anne;  Cardiology Department, Trousseau Hospital, University of Tours, Tours, France.
Bière, Loic;  Institut MITOVASC, UMR INSERM U1083 and CNRS 6015, Service de Cardiologie, CHU
Habib, Gilbert;  Aix Marseille Université, IRD, APHM, MEPHI, IHU-Méditerranée Infection, France.
LANCELLOTTI, Patrizio  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service de cardiologie
Lederlin, Mathieu;  imagerie médicale-CHU de Rennes, 35000 Rennes, France.
Tribouilloy, Christophe;  Department of Cardiology, Amiens University Hospital, 1 Rue du Professeur
Oger, Emmanuel;  Pharmacologie Clinique et CIC-IP 1414, CHU Rennes et Université Rennes-1, Rennes,
Donal, Erwan;  University of Rennes, CHU Rennes, Inserm, LTSI - UMR 1099, F-35000 Rennes,
More authors (3 more) Less
Language :
English
Title :
Rational and design of the ROTAS study: a randomized study for the optimal treatment of symptomatic patients with low-gradient severe aortic valve stenosis and preserved left ventricular ejection fraction.
Publication date :
22 January 2021
Journal title :
European heart journal. Cardiovascular Imaging
eISSN :
2047-2412
Volume :
22
Issue :
2
Pages :
229-235
Peer reviewed :
Peer reviewed
Commentary :
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.
Available on ORBi :
since 24 May 2022

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