Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial)
American Heart Journal, vol. 228, pp. 27–35
Abstract
BACKGROUND: Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk. METHODS/DESIGN: The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life. DISCUSSION: The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis. TRIAL REGISTRATION: clinicaltrials.gov: NCT04160130.
Authors 14
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Centre Hospitalier Universitaire de Rouen
Affiliation as printed
Department of Cardiology, Rouen University Hospital, FHU REMOD-VHF, Rouen, France. Electronic address: helene.eltchaninoff@chu-rouen.fr
Department of Cardiology, Rouen University Hospital, FHU REMOD-VHF, Rouen, France
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Innsbruck Medical University · Universität Innsbruck
Affiliation as printed
Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: nikolaos.bonaros@tirol-kliniken.at
Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria
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Affiliation as printed
St. Thomas' Hospital, London, United Kingdom. Electronic address: bernard.prendergast@gstt.nhs.uk
St. Thomas' Hospital, London, United Kingdom
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Hirslanden Klinik Im Park · Klinik Hirslanden
Affiliation as printed
CardioVascularCenter, Hirslanden Klinik Im Park, Zurich, Switzerland. Electronic address: fabian.nietlispach@hirslanden.ch
CardioVascularCenter, Hirslanden Klinik Im Park, Zurich, Switzerland
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Affiliation as printed
University Heart Center Frankfurt, Frankfurt, Germany. Electronic address: mariuca.vasa-nicotera@kgu.de
University Heart Center Frankfurt, Frankfurt, Germany
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IRCCS Ospedale San Raffaele · Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele
Affiliation as printed
Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it
Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy
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Institut universitaire de cardiologie et de pneumologie de Québec · Université Laval
Affiliation as printed
Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, QC, Canada. Electronic address: philippe.pibarot@med.ulaval.ca
Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, QC, Canada
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Affiliation as printed
Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. Electronic address: peter.bramlage@ippmed.de
Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany
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Affiliation as printed
Edwards Lifesciences, Prague, Czech Republic. Electronic address: lenka_sykorova@edwards.com
Edwards Lifesciences, Prague, Czech Republic
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Affiliation as printed
Edwards Lifesciences, Prague, Czech Republic. Electronic address: jana_kurucova@edwards.com
Edwards Lifesciences, Prague, Czech Republic
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Leiden University Medical Center
Affiliation as printed
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: j.j.bax@lumc.nl
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands
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Affiliation as printed
Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: Stephan.Windecker@insel.ch
Department of Cardiology, Bern University Hospital, Bern, Switzerland
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Affiliation as printed
Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: ndumonteil@clinique-pasteur.com
Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France
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Didier Tchétché corresponding
Affiliation as printed
Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: dtchetche@clinique-pasteur.com
Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France
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