1-year clinical outcomes in women after transcatheter aortic valve replacement. results from the first WIN-TAVI registry

Objectives This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex–specific characteristics on composite 1-year clinical outcomes. Background Women comprise ≥50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex. Methods The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis, across 18 sites in Europe and 1 site in the United States, between January 2013 and December 2015. The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction beyond 30 days. Secondary endpoints included composite 1-year death or stroke. Predictors of 1-year outcomes were determined using Cox regression methods. Results A total of 1,019 intermediate to high-risk women, with mean age 82.5 ± 6.3 years, mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) I 17.8 ± 11.7% and mean Society of Thoracic Surgeons score 8.3 ± 7.4% were enrolled. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. The primary VARC-2 efficacy composite endpoint occurred in 111 (10.9%) patients beyond 30 days and in 167 (16.5%) patients at 1 year. The incidence of 1-year death or stroke was 13.9% (n = 141). Death occurred in 127 (12.5%) patients and stroke in 22 (2.2%) patients. Prior coronary revascularization (hazard ratio [HR]: 1.72; 95% confidence interval [CI]: 1.17 to 2.52; p = 0.006) and EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.027) were independent predictors of the VARC-2 efficacy endpoint. Similarly, EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.013), baseline atrial fibrillation (HR: 1.58; 95% CI: 1.07 to 2.33; p = 0.022), and prior percutaneous coronary intervention (HR: 1.50; 95% CI: 1.03 to 2.19; p = 0.035) were independent predictors of 1-year death or stroke. After adjustment, no significant association was observed between history of pregnancy or any sex-specific factors and 1-year TAVR outcomes. Conclusions Intermediate to high-risk women enrolled in this first ever all-women contemporary TAVR registry experienced a 1-year VARC-2 composite efficacy endpoint of 16.5%, with a low incidence of 1-year mortality and stroke. Prior revascularization and EuroSCORE I were independent predictors of the VARC-2 efficacy endpoint, whereas EuroSCORE I, baseline atrial fibrillation, and prior percutaneous coronary intervention were independent predictors of the 1-year death or stroke.