Abstract 4368682: Two-year Outcomes for Women in the 5-year SMART Trial

Background: The Small Annuli Randomized To Evolut or SAPIEN Trial (SMART, NCT04722250; Medtronic funded) compares the performance of Evolut and SAPIEN transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis and small aortic annuli (SAA). These patients, predominantly women (87%), have risk for impaired valve hemodynamics. At 1 year, women in this trial had similar clinical outcomes with both devices but significantly lower bioprosthetic valve dysfunction (BVD) with Evolut. Here we report 2-year outcomes for women. Research Question: For women with a SAA and severe aortic stenosis who undergo TAVR with Evolut vs SAPIEN, do clinical and hemodynamic outcomes remain similar at 2 years? Methods: Key eligibility criteria included small aortic valve annulus area (≤430 mm 2 by CT) and anatomy suitable for transfemoral TAVR with either Evolut PRO/PRO+/FX or SAPIEN 3/3 Ultra valves. Coprimary endpoints include a clinical outcome composite of death, disabling stroke, or rehospitalization for heart failure, and a valve function composite for BVD, both at 1 year. Patients are being followed for 5 years. Results: A total of 621 women underwent attempted TAVR (312 Evolut, 309 SAPIEN) at 81 sites in 13 countries. Mean age was 80.2±2.2 years, and mean STS score was 3.4±1.8%. At 2 years, estimates for the clinical outcome composite were similar between groups, with 17.9% for Evolut and 18.5% for SAPIEN (log-rank p=0.81), while estimates for the BVD composite endpoint remained significantly lower for Evolut at 12.3% vs 49.1% for SAPIEN (difference -36.9% [95% confidence interval -44.6%, -29.2%], p<0.001). Rates of ≥ mild total aortic regurgitation remained similar between valve types, with 16.4% for Evolut and 19.6% for SAPIEN (p=0.38), while mean gradient (8.3±4.0 vs 16.3±6.9 mmHg, p<0.001) and effective orifice area (1.93±0.47 vs 1.48±0.35 cm 2 , p<0.001) remained significantly better for Evolut. The 2-year reintervention rate was comparable for both groups (0.7%, p>0.99), and the overall KCCQ score was similar (Evolut 80.9±19.1 vs SAPIEN 80.6±18.2, p=0.84). Conclusions: In the SMART trial, 2-year results for women showed similar rates of the clinical outcome composite between groups, however Evolut patients exhibited a significantly lower rate of BVD and significantly better hemodynamic outcomes compared to SAPIEN. These findings emphasize the hemodynamic advantage of Evolut TAVR and the importance of continued follow-up through 5 years.