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).

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: Helene Eltchaninoff, Nikolaos Bonaros, Bernard Prendergast, Fabian Nietlispach, Mariuca Vasa-Nicotera, Alaide Chieffo, Philippe Pibarot, Peter Bramlage, Lenka Sykorova, Jana Kurucova, Jeroen J Bax, Stephan Windecker, Nicolas Dumonteil, Didier Tchetche
• Journal: American heart journal (Am Heart J) Vol. 228 Pg. 27-35 (10 2020) ISSN: 1097-6744 [Electronic] United States
• PMID: 32745733 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Topics

• Aged
• Aortic Valve (diagnostic imaging, surgery)
• Aortic Valve Stenosis (diagnosis, physiopathology, psychology, surgery)
• Female
• Health Status
• Heart Valve Prosthesis (adverse effects, classification)
• Humans
• Outcome and Process Assessment, Health Care
• Postoperative Complications (diagnosis, physiopathology, prevention & control, psychology)
• Quality of Life
• Randomized Controlled Trials as Topic
• Risk Adjustment (methods)
• Risk Factors
• Severity of Illness Index
• Transcatheter Aortic Valve Replacement (adverse effects, instrumentation, methods)