March 30, 2025 — Medtronic has announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial.
Data shows, versus surgery, the Evolut transcatheter aortic valve replacement (TAVR) system delivers a numerically lower rate of all-cause mortality or disabling stroke at five years, strong valve performance and durable clinical outcomes. The findings were presented at the American College of Cardiology's Annual Scientific Session & Expo and published in the JACC, the flagship journal of the American College of Cardiology.
The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk <3%, as assessed by a local heart team. 1,414 patients were randomized, with 730 receiving TAVR with either a Medtronic Evolut R, PRO, or CoreValve™ and 684 undergoing surgery.
"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."
Patients with severe aortic stenosis who were treated with either Evolut TAVR or surgery showed comparable rates of all-cause mortality or disabling stroke at 5 years (Evolut TAVR [15.5%] and surgery [16.4%]; p=0.47). Additional findings at five years include:
- Numerically lower rate of cardiovascular mortality (7.2% Evolut TAVR vs. 9.3% surgery; p=0.15)
- Significantly larger effective orifice areas (EOA) and lower mean gradients in the TAVR vs. surgical arms
"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,[1] 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."
1Herrmann H. Two-Year Outcomes of the Five-Year SMART Trial, presented at CRT 2025.
July 31, 2024 
