Study: Medtronic Evolut TAVR Platform Outperforms Surgery

Medtronic plc is sharing promising 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, according to study data, 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, Medtronic claims. The data has been 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 trial investigator. “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. The trial defined low-risk patients as those 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% with TAVR and 22.4% with SAVR (p=0.04).
 
“The Medtronic Low Risk data 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.”
 
Headquartered in Dublin, Ireland, Medtronic is a global healthcare technology company that aims to alleviate pain, restore health, and extend life. With a global team of more than 95,000 employees across 150-plus countries, its technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 

* Versus surgery in high-risk patients on mortality at 1 year2 and vs surgery in low-risk patients on MPG and EOA at 1 year and KCCQ at 30 days3

Reference 
¹ O’Hair D, Yakubov SJ, Grubb KJ, et al. Structural valve deterioration after self-expanding transcatheter or surgical aortic valve implantation in patients at intermediate or high risk. JAMA Cardiology. 2023;8(2):111. doi:10.1001/jamacardio.2022.4627