Self-expanding TAVR valves deliver outcomes and durability comparable to surgery after 5 years
Transcatheter aortic valve replacement (TAVR) using the Evolut platform remains a safe and effective alternative to surgical aortic valve replacement (SAVR) in low-risk patients, according to new 5-year data data from the Evolute Low-Risk trial presented at ACC.25 in Chicago.
Overall, the study's primary endpoint of all-cause mortality and disabling stroke was numerically lower for Evolut than surgery. Over the study's five years, the outcome rates were statically similar for the two treatment options.
"Seeing cardiovascular mortality, which really has to do with valve function and performance, staying similar to surgery, but even widening in favor gives us great confidence that Evolut is a safe and effective treatment for aortic stenosis versus surgery," principal investigator Michael J. Reardon, MD, the Allison Family Distinguished Chair in Cardiovascular Research and a professor of medicine at the DeBakey Heart and Vascular Center at Houston Methodist Hospital, explained. He spoke to Cardiovascular Business at ACC.25.
Hemodynamic performance and stroke risk
The trial enrolled 1,414 patients with severe aortic stenosis who had a surgical risk of 3% or less, as assessed by STS score and heart team evaluation. Patients were randomized to receive either TAVR with the Evolut valve or SAVR.
Reardon emphasized that disabling stroke rates remained flat across the study period and comparable between the two treatment arms.
“We saw no divergence in disabling stroke rates, which is reassuring. It shows that TAVR does not introduce added neurological risk over time,” he noted.
In addition to clinical endpoints, TAVR continued to demonstrate superior hemodynamic performance across all time points.
“We saw sustained hemodynamic advantage for Evolut versus surgery, which we attribute to the self-expanding nitinol design,” Reardon said. “Notably, mild paravalvular leaks actually decreased over time, likely due to valve expansion and remodeling against the native annulus.”
The secondary clinical endpoints included hemodynamics and quality of life. Reardon said hemodynamics had a sustained, superior outcome for TAVR versus surgery at all time points.
"Another important finding was the paravalvular leak rate of moderate or greater, and there was no difference between Evolut and surgery. Quality of life had no difference, and that is really important to our patients; they want to be alive and feel better. TAVR makes you live as long as surgery and has no more strokes than surgery," Reardon explained.
The trial also showed a decrease in paravalvular leaks over time. Reardon said that was expected because the nitinol self-expanding valve continues to expand and will remodel the calcium of the annulus as it does.
Mild paravalvular leaks, he added, did not appear to impact patient mortality.
Quality of life and durability
Importantly for patients, quality-of-life outcomes were comparable between groups. Over 70% of Evolut patients achieved a Kansas City Cardiomyopathy Questionnaire (KCCQ) score indicative of NYHA Class I function—meaning they felt well and asymptomatic—versus just under 70% in the surgical group.
"You have a quality of life that's equal to surgery. So if you're living, have no strokes and you're feeling better, TAVR looks like a very strong candidate," Reardon said.
The data also provide valuable insight into valve durability. With five-year outcomes holding strong and further longitudinal follow-up planned, TAVR continues to build a compelling case for lifetime management strategies, especially in patients over 65.
Valve choice and patient selection
While Evolut’s performance in this trial was impressive, Reardon acknowledged the importance of personalized valve selection. He said the Medtronic Evolut and Edwards Lifesciences Sapien 3 platforms have differences that make one or the other better fits for certain patients.
“Both Evolut and Sapien 3 are excellent valves. The decision ultimately comes down to anatomy, patient age, lifestyle and long-term goals,” he explained.
In smaller annulus patients, who are often women, the Evolut system has shown particular benefits due to better hemodynamic profiles, as supported by the SMART Trial two-year data presented back in March.
"When you think about valve choice, right now you can look at this data and look your patient in eye," Reardon concluded. "If they are 65 or older, they fit this trial. We can tell them that in five years, this looks really good."
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]