BACKGROUND AND AIMS: Although women with severe symptomatic aortic stenosis have more complications than men when undergoing surgical valve replacement, they are under-represented in clinical trials. The Randomized researcH in womEn all comers wIth Aortic stenosis (RHEIA) trial investigates the balance of benefits and risks of transcatheter aortic valve implantation (TAVI) vs. surgery in women. METHODS: Women were randomized 1:1 to transfemoral TAVI with a balloon-expandable valve or surgery. The primary composite endpoint was death, stroke, or (valve, procedure or heart failure related) rehospitalization at 1 year. Non-inferiority testing with a pre-specified 6% margin and superiority testing were performed in the as-treated population. RESULTS: At 48 European centres, 443 women underwent randomization, and 420 were treated as randomized. Mean age was 73 years, and the mean estimated surgical risk of death was 2.1% (Society of Thoracic Surgeons risk score). Kaplan-Meier estimates of the primary endpoint event rates at 1 year were 8.9% in the TAVI and 15.6% in the surgery group. This difference of -6.8% with an upper 95% confidence limit of -1.5% demonstrated the non-inferiority of TAVI (P < .001). The two-sided 95% confidence interval of -13.0% to -.5% further resulted in superiority (P = .034). The 1-year incidence of the primary endpoint components was: .9% with TAVI vs. 2.0% with surgery for death from any cause, 3.3% vs. 3.0% for stroke, and 5.8% vs. 11.4% for rehospitalization. CONCLUSIONS: Among women with severe aortic stenosis, the incidence of the composite of death, stroke, or rehospitalization at 1 year was lower with TAVI than with surgery. CLINICALTRIALS.GOV NUMBER: NCT04160130.

Cardiology Department Hospital Sindelfingen Böblingen Sindelfingen Germany

Chirugie cardiaque CHU Montpellier Hopital Arnaud de Villeneuve Montpellier France

Chirurgie thoracique cardiaque et vasculaire CHU Rennes Hopital de Pontchaillou Rennes France

Clinic for General and Interventional Cardiology Angiology Heart and Diabetes Center North Rhine Westphalia Bad Oeynhausen Germany

Department of Cardiac and Thoracic Surgery Clinic Pasteur Toulouse France

Department of Cardiac Surgery Medical University of Innsbruck Innsbruck Austria

Department of Cardiac Surgery Medical University of Vienna Vienna Austria

Department of Cardiology Inselspital University of Bern Bern Switzerland

Department of Cardiology Leiden University Medical Center Leiden The Netherlands

Department of Cardiology Montpellier University Hospital Montpellier France

Department of Cardiology Quebec Heart and Lung Institute Laval University Quebec City QC Canada

Department of Cardiology St Antonius Hospital Nieuwegein The Netherlands

Department of Cardiology St Antonius Ziekenhuis Nieuwegein Nieuwegein The Netherlands

Department of Data Science Institute for Clinical and Experimental Medicine Prague Czech Republic

Department of Heart Surgery University Hospital Sankt Pölten Karl Landsteiner University of Medical Science Krems Austria

Department of Internal Medicine 3 Cardiology University Hospital Sankt Pölten Karl Landsteiner University of Medical Science Krems Austria

Department of Interventional Cardiology Cardiology Hospital of the Haut Lévêque University of Bordeaux Pessac France

Department of Medical Statistics London School of Hygiene and Tropical Medicine London WC1E7HT UK

Department of Thoracic and Cardiovascular Surgery Heart and Diabetes Center North Rhine Westphalia Bad Oeynhausen Germany

Division of Cardiology Department of Internal Medicine 2 Medical University of Vienna Vienna Austria

Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada

Groupe Cardiovasculaire Interventionnel Clinique Pasteur 45 avenue de Lombez 31076 Toulouse Cedex 3 France

Hart Long Centrum Leids Universitair Medisch Centrum Leiden The Netherlands

HeartCenter Im Park Hirslanden Klinik Im Park Zurich Switzerland

Inserm U1096 CHU Rouen Department of Cardiology Univ Rouen Normandie F 76000 Rouen France

Institute for Pharmacology and Preventive Medicine Cloppenburg Germany

Interventional Cardiology Unit IRCCS San Raffaele Scientific Institute Milan Italy

Medical Affairs Edwards Lifesciences Prague Czech Republic

Service de Cardiologie CHU de Rennes Inserm LTSI U1099 Université de Rennes 1 35000 Rennes France

Service Médico chirurgical de cardiologie CHU de Bordeaux Pessac France

St Thomas' Hospital London United Kingdom

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ClinicalTrials.gov
NCT04160130