Medtronic’s Evolut TAVR System Evaluated in Low-Risk Patients at 5 Years

March 30, 2025—Medtronic announced 5-year outcomes from the Evolut Low-Risk Trial. The randomized, multicenter, international study assessed the safety and efficacy of the company’s Evolut transcatheter aortic valve replacement (TAVR) system versus surgery in low-risk patients.

Medtronic stated that the study showed that the Evolut system delivered a numerically lower rate of all-cause mortality or disabling stroke at 5 years, strong valve performance, and durable clinical outcomes. The data were presented as late-breaking clinical science at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago, Illinois. The study was simultaneously published online by John K. Forrest, MD, et al in JACC.

According to the company, patients in the study had a predicted 30-day mortality risk of < 3%, as assessed by a local heart team. Investigators randomized 1,414 patients—730 patients received TAVR with Medtronic’s Evolut R, Evolut Pro, or CoreValve; 684 patients underwent surgery.

As summarized in Medtronic’s press release, 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 (15.5% vs 16.4%; P = .47). There was a numerically lower rate of cardiovascular mortality for Evolut TAVR compared to surgery at 5 years (7.2% vs 9.3%; P = .15). Additionally, there were significantly larger effective orifice areas and lower mean gradients in the TAVR arm versus the surgical arm.

The principal investigator of the trial is Michael J. Reardon, MD. Dr. Reardon is the Allison Family Distinguished Chair of Cardiovascular Research and Professor of Cardiothoracic Surgery at the Houston Methodist Hospital in Houston, Texas.

“Results at 5 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,” commented Dr. Reardon in Medtronic’s press release. “The lower mortality risk and strong valve performance are meaningful for clinicians in evaluating treatment approaches that prioritize the overall well-being of patients.”