Transcatheter vs. Surgical Aortic Valve Replacement in Women: The RHEIA Trial

Women with severe symptomatic aortic stenosis are underrepresented 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) compared to surgery in women. Women were randomized 1:1 to received either transfemoral TAVI with a balloon-expandable valve or surgical intervention. The primary composite endpoint was defined as death, stroke, or rehospitalization related to the valve, procedure, or heart failure within one year. Non-inferiority testing was conducted using a prespecified margin of 6 percent, alongside superiority testing in the as-treated population.  At 48 European centers, 443 women were randomized, with 420 receiving treatment as randomized. The mean age of participants was 73 years, and the mean estimated surgical risk of death was 2.1 percent, as determined by the Society of Thoracic Surgeons risk score. Kaplan–Meier estimates of the primary endpoint event rates at one year were 8.9 percent in the TAVI group and 15.6 percent in the surgery group. This difference of −6.8 percent, with an upper 95 percent confidence limit of −1.5 percent, demonstrated the non-inferiority of TAVI (P < 0.001). The two-sided 95 percent confidence interval of −13.0 percent to −0.5 percent further resulted in superiority (P = 0.034). The one-year incidence of the primary endpoint components was as follows: 0.9 percent for TAVI vs. 2.0 percent for surgery for death from any cause; 3.3 percent vs. 3.0 percent for stroke; and 5.8 percent vs. 11.4 percent for rehospitalization.  The authors concluded that among women with severe aortic stenosis, the incidence of the composite of death, stroke, or rehospitalization at one year was lower in the TAVI group compared to the surgery group.