Transcatheter vs. surgical aortic valve replacement in women: the RHEIA trial.

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.