Late-breaking data from Medtronic's Evolut Low Risk Trial has demonstrated durable clinical outcomes and outstanding valve performance at the five-year mark, potentially reshaping treatment approaches for patients with severe aortic stenosis.
The findings, presented at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in the Journal of the American College of Cardiology (JACC), showed that Medtronic's Evolut transcatheter aortic valve replacement (TAVR) system delivered comparable rates of all-cause mortality or disabling stroke compared to surgical valve replacement at five years.
Durable Outcomes Challenge Surgical Standard
The randomized, multicenter, international Evolut Low Risk Trial assessed the safety and efficacy of the Evolut TAVR system versus surgery in 1,414 patients with severe aortic stenosis who had a predicted 30-day mortality risk of less than 3%. At the five-year mark, the data revealed:
- Comparable rates of all-cause mortality or disabling stroke: 15.5% for Evolut TAVR versus 16.4% for surgery (p=0.47)
- Numerically lower rate of cardiovascular mortality: 7.2% for Evolut TAVR versus 9.3% for surgery (p=0.15)
- Significantly larger effective orifice areas (EOA) and lower mean gradients in the TAVR arm compared to the surgical arm
"Results at five 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," said Michael J. Reardon, M.D., Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital and principal investigator of the trial.
The durability question has been a critical factor in determining whether TAVR should be used in younger, lower-risk patients who may live with their valve for decades. These five-year results provide important reassurance about the long-term performance of the Evolut system.
Superior Hemodynamics May Provide Clinical Advantage
The Evolut data builds upon recently reported evidence from the SMART trial, which directly compared Medtronic's Evolut system to Edwards Lifesciences' SAPIEN system—currently the market leader with over 60% of the U.S. TAVR market, according to GlobalData.
The SMART trial's two-year results showed that the Evolut system demonstrated significantly less bioprosthetic valve dysfunction, five times less prosthetic valve thrombosis, and nine times less hemodynamic structural valve dysfunction than the SAPIEN system. These findings were particularly notable for women with symptomatic severe aortic stenosis and small aortic annulus.
"At five years, Evolut has demonstrated lasting clinical outcomes comparable to surgery and a trend toward reduced cardiovascular mortality," said Kendra J. Grubb, M.D., M.H.A., M.Sc., vice president and chief medical officer of Structural Heart at Medtronic. "These results reinforce the recently reported Evolut evidence from the SMART trial, which emphasized superior hemodynamics and lower rates of valve dysfunction."
Implications for Clinical Practice and Market Dynamics
The five-year data from the Evolut Low Risk Trial, combined with the comparative data from the SMART trial, could potentially shift treatment paradigms and market dynamics in the TAVR space.
For clinicians, these results provide valuable information for making personalized treatment decisions for younger, lower-risk patients with severe aortic stenosis. The data suggests that TAVR with the Evolut system can be considered a safe and durable alternative to surgery, with potential hemodynamic advantages.
From a market perspective, industry analysts suggest that the completion of the five-year SMART trial comparing Evolut to SAPIEN could potentially disrupt Edwards Lifesciences' dominant position in the U.S. TAVR market. However, healthcare facilities may not yet be ready to make significant purchasing shifts based on interim results, as factors such as price, ease of use, and established relationships also influence procurement decisions.
The Evolution of TAVR Technology
The Evolut TAVR system features a supra-annular, self-expanding design that differs from balloon-expandable valves like the SAPIEN. This design appears to contribute to its superior hemodynamic performance, which may be particularly beneficial for certain patient populations.
The Evolut Low Risk Trial included patients treated with either Medtronic Evolut R, PRO, or CoreValve™ systems, representing the evolution of the company's TAVR technology. The consistent performance across these iterations suggests that the fundamental design principles of the Evolut platform contribute to its clinical outcomes.
As TAVR technology continues to advance and longer-term data becomes available, the treatment landscape for aortic stenosis will likely continue to evolve, with potential benefits for the growing population of patients with this condition.
