26th October, 2023
TCT 2023: Medtronic adds to the body of evidence for Evolut TAVR with late-breaking clinical trial data from the Evolut Low Risk Trial
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Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced four-year results from the Evolut Low Risk Trial. The Medtronic Evolut™ transcatheter aortic valve replacement (TAVR) system demonstrated exceptional outcomes and sustained valve performance, proven by significantly better hemodynamics than surgical aortic valve replacement (SAVR). Only Evolut TAVR has reported consistently lower and diverging rates of death or disabling stroke versus state-of-the-art surgery, at four years. The data were presented at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation and simultaneously published in the Journal of the American College of Cardiology.
Since the approval of TAVR in low-risk surgical patients, there is an ongoing need for evidence to better understand the intermediate and longer-term durability of TAVR devices of different designs.
"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," said 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. "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.1 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."
The Evolut™ Low Risk Trial was a prospective, randomized, multicenter, international, noninferiority study to assess the safety and efficacy of the Evolut TAVR system compared to surgical aortic valve replacement (SAVR) in low-risk patients. Low-risk patients, defined in the trial as having a predicted risk of 30-day mortality <3% per multidisciplinary local heart team assessment, were randomized to TAVR with a Medtronic self-expanding, supra-annular Evolut R, PRO, or CoreValve™ bioprosthesis vs. SAVR. A total of 1,414 patients underwent attempted implant (730 TAVR; 684 SAVR).
The study showed continued favorable outcomes for Evolut TAVR compared to SAVR at four years for the primary endpoint of all-cause mortality or disabling stroke. At four years, a 26% relative reduction in the hazard (p= 0.05) of death or disabling stroke with TAVR (10.7%) was seen compared to SAVR (14.1%). The absolute difference between treatment arms for the primary endpoint continued to increase over time, representing a clinical benefit from Evolut TAVR for patients at four years compared to surgery. The findings also showed the composite of all-cause mortality, disabling stroke, or aortic valve rehospitalization was 18.0% with TAVR and 22.4% with SAVR (p=0.04).
"The Medtronic Low Risk data presented today at TCT demonstrates our continued commitment to generating evidence on our Evolut TAVR platform and providing treatment options for low-risk symptomatic severe aortic stenosis patients, a growing patient population," said Nina Goodheart, senior vice president and president of the Structural Heart & Aortic business within the Cardiovascular Portfolio at Medtronic. "We are dedicated to supporting advanced, lifelong patient care by empowering physicians with the latest minimally invasive, clinically proven technology to best treat their patients."