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Transcatheter vs. surgical aortic valve replacement in women: the RHEIA trial
D. Tchetche, P. Pibarot, JJ. Bax, N. Bonaros, S. Windecker, N. Dumonteil, F. Nietlispach, D. Messika-Zeitoun, SJ. Pocock, P. Berthoumieu, MJ. Swaans, L. Timmers, TK. Rudolph, S. Bleiziffer, L. Leroux, T. Modine, F. van der Kley, V. Auffret, J....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, randomizované kontrolované studie, multicentrická studie, srovnávací studie
Grantová podpora
Edwards Lifesciences
- MeSH
- aortální chlopeň * chirurgie MeSH
- aortální stenóza * chirurgie mortalita MeSH
- cévní mozková příhoda etiologie epidemiologie MeSH
- chirurgická náhrada chlopně * metody mortalita škodlivé účinky MeSH
- lidé MeSH
- pooperační komplikace mortalita epidemiologie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční chlopně umělé MeSH
- transkatetrální implantace aortální chlopně * metody mortalita škodlivé účinky MeSH
- výsledek terapie MeSH
- znovupřijetí pacienta statistika a číselné údaje MeSH
- Check Tag
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
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
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 Medical Statistics London School of Hygiene and Tropical Medicine London WC1E7HT UK
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
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
Citace poskytuje Crossref.org
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