
Medtronic Evolut Trial Combined With Partner 3 Data May Be Nail in Coffin for Surgical Aortic Valves; Data Shows Lower Mortality With TAVR
Medtronic announced new four-year results from the Evolut Low Risk Trial, highlighting the outstanding performance and sustained valve durability of the Medtronic Evolut™ transcatheter aortic valve replacement (TAVR) system. The results, presented at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference and published in the Journal of the American College of Cardiology, reveal positive long-term outcomes, especially when compared to surgical aortic valve replacement (SAVR). In combination with recent data from the Partner 3 study this week, these data sets could be the nail in the coffin driving broad adoption of TAVR even for low-risk surgical patients. TAVR first exceeded surgery in 2020 and is already the dominant procedure performed in the U.S. with approximately 100,000 aortic valve replacements annually.
The Evolut™ Low Risk Trial was a comprehensive study designed to assess the safety and efficacy of the Medtronic Evolut TAVR system in low-risk patients. These patients had a predicted risk of 30-day mortality of less than 3%, according to assessments by multidisciplinary local heart teams. The trial included 1,414 patients who underwent either TAVR with a Medtronic self-expanding Evolut bioprosthesis or SAVR.
The findings of the trial demonstrate the continued success of the Evolut TAVR system, especially in comparison to SAVR. At four years, the TAVR arm showed a 26% relative reduction in the hazard of death or disabling stroke compared to the SAVR arm. The absolute difference in the primary endpoint between the two treatment options continued to grow over time, indicating a distinct clinical advantage of the Evolut TAVR system. Furthermore, the composite of all-cause mortality, disabling stroke, or aortic valve rehospitalization was lower with TAVR (18.0%) compared to SAVR (22.4%) at four years.
Dr. Michael Reardon, Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital and principal investigator of the trial, commented on these results. He stated, “As we see patients in the Evolut Low Risk trial continue to show positive outcomes and sustained valve performance compared to surgery out to four years, this helps us establish intermediate-term evidence for Evolut TAVR and helps define what this might look like in the long term. These results are not only encouraging but pivotal in shaping treatment decisions for low-risk patients with symptomatic severe aortic stenosis. We are seeing sustained, excellent valve performance in patients treated with Evolut TAVR, which ultimately translates into improved outcomes, including mortality and disabling stroke. This intermediate-term result underscores the belief that valve design matters, and previously published data points to superior outcomes and better design in the Evolut TAVR platform.”