TY - JOUR
T1 - Transcatheter vs. surgical aortic valve replacement in women
T2 - the RHEIA trial
AU - Tchetche, Didier
AU - Pibarot, Philippe
AU - Bax, Jeroen J
AU - Bonaros, Nikolaos
AU - Windecker, Stephan
AU - Dumonteil, Nicolas
AU - Nietlispach, Fabian
AU - Messika-Zeitoun, David
AU - Pocock, Stuart J
AU - Berthoumieu, Pierre
AU - Swaans, Martin J
AU - Timmers, Leo
AU - Rudolph, Tanja Katharina
AU - Bleiziffer, Sabine
AU - Leroux, Lionel
AU - Modine, Thomas
AU - van der Kley, Frank
AU - Auffret, Vincent
AU - Tomasi, Jacques
AU - Stastny, Lukas
AU - Hengstenberg, Christian
AU - Andreas, Martin
AU - Leclercq, Florence
AU - Gandet, Thomas
AU - Mascherbauer, Julia
AU - Trescher, Karola
AU - Prendergast, Bernard
AU - Vasa-Nicotera, Mariuca
AU - Chieffo, Alaide
AU - Mares, Jan
AU - Wesselink, Wilbert
AU - Rakova, Radka
AU - Kurucova, Jana
AU - Bramlage, Peter
AU - Eltchaninoff, Helene
N1 - © The Author(s) 2025. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact [email protected] for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact [email protected].
PY - 2025/4/2
Y1 - 2025/4/2
N2 - 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.
AB - 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.
U2 - 10.1093/eurheartj/ehaf133
DO - 10.1093/eurheartj/ehaf133
M3 - Journal article
C2 - 40171878
SN - 0195-668X
JO - European Heart Journal
JF - European Heart Journal
ER -