Transcatheter vs. surgical aortic valve replacement in women: the RHEIA trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F25%3A00085652" target="_blank" >RIV/00023001:_____/25:00085652 - isvavai.cz</a>
Result on the web
<a href="https://academic.oup.com/eurheartj/article/46/22/2079/8103699" target="_blank" >https://academic.oup.com/eurheartj/article/46/22/2079/8103699</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1093/eurheartj/ehaf133" target="_blank" >10.1093/eurheartj/ehaf133</a>
Alternative languages
Result language
angličtina
Original language name
Transcatheter vs. surgical aortic valve replacement in women: the RHEIA trial
Original language description
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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European heart journal
ISSN
0195-668X
e-ISSN
1522-9645
Volume of the periodical
46
Issue of the periodical within the volume
22
Country of publishing house
GB - UNITED KINGDOM
Number of pages
10
Pages from-to
"2079–2088"
UT code for WoS article
001460598700001
EID of the result in the Scopus database
2-s2.0-105008466703