The SMART trial assessed patients with aortic stenosis and a small aortic annulus. At two years, the study found comparable composite outcomes, including mortality, disabling stroke and heart failure hospitalization between Medtronic’s Evolut TAVR and Edwards Lifesciences’ Sapien TAVR system. According to Medtronic, Evolut demonstrated significantly lower bioprosthetic valve dysfunction (BVD) rates, which can usually indicate adverse outcomes.
“Valve performance is critical for all patients, but the impact of poor valve performance is magnified in patients with a small aortic annulus, who are at risk of receiving a valve that is not adequate for their cardiac requirements,” said Dr. Howard Herrmann, Perelman School of Medicine at the University of Pennsylvania, and lead investigator of the trial. “The two-year results highlight the continued superior performance of the Evolut TAVR valve in these patients. While we would not yet expect to see a significant difference in the composite clinical outcomes at this early stage, valve performance provides important data that operators can use to inform and personalize treatment decisions to enhance patient outcomes.”
Key findings from the two-year data include:
- Evolut TAVR had five times less prosthetic valve thrombosis compared to Sapien TAVR.
- Evolut TAVR had nine times less hemodynamic structural valve dysfunction than Sapien TAVR.
The SMART Trial is an international, multi-center, randomized post-market study evaluating the safety and performance of Evolut self-expanding TAVR versus Sapien balloon-expandable TAVR. It is the largest randomized control trial to primarily enroll women, with 87% of the 716 female patients. Conducted at over 80 sites worldwide, the study includes patients with an aortic valve annulus area of ≤430 mm who were suitable for transfemoral TAVR with either an Evolut PRO/PRO+/FX or a SAPIEN 3™/3 Ultra valve.
“The SMART trial is a groundbreaking, head-to-head comparison that, for the first time, highlights how a patient with a small annulus can benefit from Evolut’s differentiated valve design,” said Dr. Kendra Grubb, VP and chief medical officer os structural heart at Medtronic. “At two years, we continue to see superior valve performance that we will follow to assess long-term outcomes.”
The findings were presented as late-breaking science at the Cardiovascular Research Technologies 2025 conference.
