Medtronic releases two-year results of SMART trial for TAVR

Medtronic (MDT) released the two-year results of the SMall Annuli Randomized To Evolut or SAPIEN, SMART, Trial, the largest international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement, TAVR. In patients with aortic stenosis and a small aortic annulus, results showed comparable composite outcome of mortality, disabling stroke, and heart failure hospitalization, and continued superior valve performance as measured by bioprosthetic valve dysfunction, BVD, at two years for Evolut TAVR compared to SAPIEN. The late-breaking science was presented at the Cardiovascular Research Technologies, CRT, 2025 conference in Washington, D.C. The SMART two-year data demonstrated that Evolut TAVR continues to show significantly less BVD, which can be a predictor of adverse outcomes1, compared to SAPIEN TAVR. Additional results demonstrated that Evolut TAVR showed the following relative to SAPIEN TAVR: Five times less prosthetic valve thrombosis; Nine times less hemodynamic structural valve dysfunction.