Medtronic’s SMART Trial Confirms Evolut™ TAVR’s Superior Valve Performance at Two Years

Medtronic plc , a global leader in healthcare technology,  announced the two-year results of the SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial—the largest international head-to-head comparative study of transfemoral transcatheter aortic valve replacement (TAVR). The findings, presented as late-breaking science at the Cardiovascular Research Technologies (CRT) 2025 conference, demonstrated comparable clinical outcomes between Evolut™ and SAPIEN™ TAVR valves in patients with aortic stenosis and a small aortic annulus, while Evolut TAVR continued to show superior valve performance and significantly lower rates of bioprosthetic valve dysfunction (BVD) at two years.

"Valve performance is critical, especially in patients with a small aortic annulus, where suboptimal valve selection can lead to long-term complications," said Howard C. Herrmann, M.D., Perelman School of Medicine at the University of Pennsylvania and lead investigator of the trial. "The two-year results reinforce the superior performance of Evolut TAVR, which operators can consider when tailoring treatment to optimize patient outcomes." The study found that Evolut TAVR demonstrated five times less prosthetic valve thrombosis (p=0.0048) and nine times less hemodynamic structural valve dysfunction (p<0.001) compared to SAPIEN TAVR.

The SMART Trial is a global, prospective, multi-center, randomized (1:1) post-market trial evaluating the safety and performance of Evolut self-expanding TAVR versus SAPIEN balloon-expandable TAVR in patients with symptomatic severe aortic stenosis and small aortic annulus. The trial enrolled 716 patients—87% of whom were women—across more than 80 sites worldwide. Eligible patients had an aortic annulus area of ≤430 mm² and were deemed suitable for transfemoral TAVR with either an Evolut PRO/PRO+/FX or SAPIEN 3™/3 Ultra™ valve.

"The SMART Trial provides crucial insights into how patients with small annuli can benefit from Evolut’s differentiated valve design," said Kendra J. Grubb, M.D., M.H.A, M.Sc., vice president and chief medical officer, Structural Heart at Medtronic. "At two years, we continue to observe superior valve performance, and we look forward to monitoring long-term outcomes as the study progresses." Patients in the SMART Trial will continue to be followed for up to five years, further advancing evidence-based decision-making in TAVR treatment strategies.