Evolut TAVR demonstrated “exceptional outcomes and sustained valve performance,” Medtronic says. It showed significantly better hemodynamics than surgical aortic valve replacement (SAVR). The company presented the data at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Results were simultaneously published in the Journal of the American College of Cardiology.
Medtronic says that, since the approval of TAVR in low-risk patients, there remains a need for durability evidence. The company aims to provide intermediate and longer-term durability data on TAVR devices of different designs.
The Evolut Low-Risk Trial, a prospective, randomized, multi-center, international noninferiority study compared Evolut TAVR to SAVR. It evaluated the safety and efficacy of TAVR in low-risk patients. Low-risk patients, defined 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.
Medtronic says a total of 1,414 patients underwent attempted implant (730 TAVR, 684 SAVR). Dr. Michael Reardon, principal investigator, said the encouraging results can help shape treatment decisions. Reardon, a professor of cardiothoracic surgery at the Houston Methodist Hospital, said it helps define TAVR evidence 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,” Reardon said. “We are seeing sustained, excellent valve performance in patients treated with Evolut TAVR, which ultimately translates into improved outcomes, including mortality and disabling stroke.”
The data from Medtronic
Medtronic reported continued favorable outcomes for Evolut TAVR compared to SAVR at four years. It set the primary endpoint of all-cause mortality or disabling stroke.
At four years, the study saw a 26% relative reduction in the hazard of death or disabling stroke with TAVR (10.7%). That compared to 14.1% in the SAVR arm. The absolute difference between treatment arms for the primary endpoint continued to increase over time. Medtronic says that represents a clinical benefit from Evolut TAVR for patients at four years compared to surgery.
“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,” Reardon said.
Findings also demonstrated an 18% composite of all-cause mortality, disabling stroke or aortic valve rehospitalization with TAVR. That compared to a 22.4% composite with SAVR.
“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, SVP and president of the Structural Heart & Aortic 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.”
