SMART Trial two-year data continues to demonstrate superior valve performance for Evolut TAVR™ system in small annulus patients

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CRT 2025 Late Breaking Science features largest head-to-head randomized control TAVR trial to primarily enroll women using the two most widely used global TAVR devices

GALWAY, Ireland and WASHINGTON, March 9, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today 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.

"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, M.D., 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 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 (p=0.0048)
  • Nine times less hemodynamic structural valve dysfunction (defined by mean gradient ≥ 20mmHg; p

    The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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