Medtronic announced that its Evolut transcatheter aortic valve replacement (TAVR) system showed durable clinical outcomes in patients with low-risk aortic stenosis.
The announcement is based on five-year data from the Evolut Low Risk clinical trial.
According to the study data, the Evolut TAVR system results in a numerically lower rate of all-cause mortality or disabling stroke compared to traditional surgery.
The study results were unveiled at the American College of Cardiology’s Annual Scientific Session and published in the Journal of the American College of Cardiology.
Medtronic Structural Heart vice president and chief medical officer Kendra Grubb said: “At five years, Evolut has demonstrated lasting clinical outcomes comparable to surgery and a trend toward reduced cardiovascular mortality.
“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.”
The Evolut Low Risk Trial is a randomised, multicentre, international study that assessed the safety and efficacy of the Evolut TAVR system, compared to surgical procedures.
The trial involved 1,414 low-risk patients, of whom 730 received TAVR using Medtronic’s Evolut R, PRO, or CoreValve, and 684 underwent surgery.
Patients with severe aortic stenosis treated with either Evolut TAVR or surgery showed similar rates of all-cause mortality or disabling stroke at five years, with Evolut TAVR.
In addition, the five-year results showed a numerically lower rate of cardiovascular mortality for Evolut TAVR at 7.2% compared to 9.3% for surgery.
The TAVR group also showed significantly larger effective orifice areas and lower mean gradients than the surgical group, validating the Evolut system’s valve performance.
The trial principal investigator Michael Reardon said: “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.
“The lower mortality risk and strong valve performance is meaningful for clinicians in evaluating treatment approaches that prioritise the overall well-being of patients.”
