Data Backs Medtronic’s Evolut TAVR for Small Aortic Annulus Patients

Medtronic released the two-year results from its Small Annuli Randomized To Evolut or Sapien (SMART) trial, the largest head-to-head comparative study of transfemoral transcatheter aortic valve replacement (TAVR).

The SMART trial is an international, prospective, multi-center, randomized post-market trial comparing the safety and performance of Medtronic’s Evolut self-expanding TAVR versus Edward Lifesciences’ Sapien balloon-expandable TAVR in patients with symptomatic severe aortic stenosis (AS) and small aortic annulus.

The trial is also the largest head-to-head trial to primarily enroll women. Of the 716 patients that are part of the ongoing study, 87% of them are women. Eligible patients had an aortic valve annulus area of ≤430 mm as measured by CT.

Results showed comparable composite outcomes of mortality, disabling stroke, and heart failure hospitalization in patients with aortic stenosis and a small aortic annulus. Superior valve performance measured by bioprosthetic valve dysfunction (BVD) was seen at two years for the Evolut TAVR compared to Sapien.

BVD, according to Medtronic, can be a predictor of adverse outcomes. Evolut TAVR also demonstrated five times less prosthetic valve thrombosis and nine times less hemodynamic structure valve dysfunction compared to Sapien.

“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 Howard C. Herrmann, MD, 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.”

“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 Kendra J. Grubb, M.D., M.H.A, M.Sc., VP and chief medical officer of Medtronic’s Structural Heart business. “At two years, we continue to see superior valve performance that we will follow to assess long-term outcomes.”

Last month, Medtronic Neurovascular began a strategic partnership with Brainomix, with the aim of boosting stroke care for Western European patients by integrating AI solutions into clinical practices.