ACC25: Medtronic’s Evolut TAVR Has Lower Cardiovascular Mortality at 5 Years

Medtronic announced late-breaking data on five-year outcomes from its Evolut Low Risk trial. The findings were presented at the American College of Cardiology (ACC) annual scientific session and expo.

The randomized, multicenter, international study assessed Evolut TAVR (transcatheter aortic valve replacement) versus surgery in 1,414 low-risk patients. The patients had a predicted 3-day mortality risk of under 3%. 730 patients received TAVR with either a Medtronic Evolut R, PRO, or CoreValve and 684 underwent surgery.

Aortic stenosis patients treated with either Evolut TAVR or surgery had comparable rates of all-cause mortality or disabling stroke at five years—Evolut TAVR (15.5%); surgery (16.4%).

Evolut TAVR had a numerically lower rate of cardiovascular mortality at 7.2%, with surgery at 9.3%. There were also significantly larger effective orifice areas (EOA) and lower mean gradients in the TAVR vs. surgical arm.

“Results at five years support Evolut’s supra-annular, self-expanding TAVR as a safe, effective, and durable alternative to surgery for patients with severe aortic stenosis, regardless of their surgical risk,” said Michael J. Reardon, M.D., Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital and principal investigator of the trial. “The lower mortality risk and strong valve performance is meaningful for clinicians in evaluating treatment approaches that prioritize the overall well-being of patients.”

“At five years, Evolut has demonstrated lasting clinical outcomes comparable to surgery and a trend toward reduced cardiovascular mortality,” said Kendra J. Grubb, M.D., M.H.A., M.Sc., vice president and chief medical officer of Structural Heart, which is part of the Medtronic Cardiovascular Portfolio. “These results reinforce the recently reported Evolut evidence from the SMART trial, which emphasized superior hemodynamics and lower rates of valve dysfunction. The Evolut Low Risk data presented today will help clinicians make personalized treatment decisions for younger, lower-risk patients by considering each patient’s unique needs, now acknowledging that data supports TAVR with Evolut as a safe and durable alternative to surgery.”