Latest data from the Evolut Low Risk trial demonstrate a numerically lower rate of all-cause mortality or disabling stroke at five years using the Evolut (Medtronic) transcatheter aortic valve implantation (TAVI) system compared to surgery, alongside strong valve performance and durable clinical outcomes.
The findings were presented as late-breaking clinical science at the 2025 American College of Cardiology (ACC) scientific session (29–30 March, Chicago, USA) and simultaneously published in the Journal of the American College of Cardiology (JACC).
The Evolut Low Risk Trial was a randomised, multicentre, international study assessing the safety and efficacy of the Evolut TAVI system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk <3%, as assessed by a local heart team. A total of 1,414 patients were randomised, with 730 receiving TAVI with either a Medtronic Evolut R, PRO, or CoreValve and 684 undergoing surgery.
“Results at five years support Evolut’s supra-annular, self-expanding TAVI as a safe, effective, and durable alternative to surgery for patients with severe aortic stenosis, regardless of their surgical risk,” said Michael J Reardon (Houston Methodist Hospital, Houston, USA), 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 TAVI or surgery showed comparable rates of all-cause mortality or disabling stroke at five 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), and significantly larger effective orifice areas (EOA) and lower mean gradients in the TAVI 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, 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 emphasised superior haemodynamics and lower rates of valve dysfunction. The Evolut Low Risk data presented today will help clinicians make personalised treatment decisions for younger, lower-risk patients by considering each patient’s unique needs, now acknowledging that data supports TAVI with Evolut as a safe and durable alternative to surgery.”
