Transcatheter vs. surgical aortic valve replacement in women: the RHEIA trial.
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Tchetche Didier, Pibarot Philippe, Bax Jeroen J, Bonaros Nikolaos, Windecker Stephan, Dumonteil Nicolas, Nietlispach Fabian, Messika-Zeitoun David, Pocock Stuart J, Berthoumieu Pierre, Swaans Martin J, Timmers Leo, Rudolph Tanja Katharina, Bleiziffer Sabine, Leroux Lionel, Modine Thomas, van der Kley Frank, Auffret Vincent, Tomasi Jacques, Stastny Lukas, Hengstenberg Christian, Andreas Martin, Leclercq Florence, Gandet Thomas, Mascherbauer Julia, Trescher Karola, Prendergast Bernard, Vasa-Nicotera Mariuca, Chieffo Alaide, Mares Jan, Wesselink Wilbert, Rakova Radka, Kurucova Jana, Bramlage Peter, Eltchaninoff Helene
Аннотация
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.