SMART trial one-year data demonstrates Medtronic Evolut™ TAVR platform as optimal treatment for severe aortic stenosis in patients with small annulus, which is primarily women
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New data from the SMART trial, the largest head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (TAVR), shows that the Medtronic Evolut™ TAVR platform is an optimal treatment for severe aortic stenosis in patients with small annulus, particularly women. The trial demonstrated non-inferior clinical outcomes and superior valve performance for the Evolut TAVR platform compared to the SAPIEN™ platform. The trial enrolled primarily women (87%) and showed that women have better valve performance when treated with the Evolut TAVR system. The Evolut TAVR platform met both co-primary endpoints of clinical non-inferiority and hemodynamic superiority at one year. The results highlight the need for tailored approaches and clinical evidence to inform treatment decisions for women with small aortic annuli.