Key Points:
- In the initial Evolut Low Risk Trial, patients with severe aortic stenosis who were at low surgical risk had noninferior outcomes with TAVR using a self-expanding valve compared to surgery, based on the composite endpoint of death or disabling stroke at 24 months.
- Long-term data on TAVR performance in low-risk patients remain limited, making extended follow-up crucial for guiding treatment decisions.
- At five years, patients with severe aortic stenosis at low surgical risk who underwent Evolut TAVR had similar rates of death, disabling stroke, and re interventions compared to those undergoing surgical aortic valve replacement (SAVR).
- TAVR demonstrated comparable improvements in symptoms and functional class while offering the advantage of faster recovery.
Severe aortic stenosis is a life-threatening condition requiring aortic valve replacement, with treatment options including transcatheter aortic valve replacement (TAVR) and traditional surgical aortic valve replacement (SAVR). Although TAVR has become a leading procedure for treating symptomatic severe aortic stenosis in the U.S., regardless of surgical risk, data on its long-term outcomes in low-risk patients have been limited.
At the 2025 American College of Cardiology’s Annual Scientific Session, the five-year outcomes of the Evolut Low Risk Trial were presented and simultaneously published in the Journal of the American College of Cardiology. The trial, funded by Medtronic, aimed to compare the long-term outcomes of Evolut TAVR versus SAVR in low-risk patients. This large, international, randomized trial enrolled 1,478 patients across 86 centers, with participants receiving either Evolut TAVR (737 patients) or SAVR (741 patients). The primary endpoint was the occurrence of death or disabling stroke, while secondary outcomes included reinterventions and quality of life.
A total of 1,414 patients underwent an attempted implant (n = 730 TAVR, n = 684 surgery). The mean age was 74 years (range 51-88 years), and women accounted for 35% of patients. At five years, there was no significant difference in the primary endpoint: 15.5% of TAVR patients experienced death or disabling stroke compared to 16.4% in the SAVR group. Disabling stroke rates were 3.6% for TAVR and 4% for SAVR, with no significant difference between the groups. Mortality rates were also comparable, with 13.5% of TAVR patients and 14.9% of SAVR patients dying from any cause.
“The outcomes of all-cause mortality and disabling stroke remain similar between TAVR and surgery, though numerically, TAVR remains better,” said Dr. Michael J. Reardon, senior author of the study. “TAVR has also demonstrated similar improvements in symptoms and functional status, and with no difference in re-interventions, it remains a highly effective treatment for low-risk patients.”
Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), remained high for both groups, with approximately 70% of patients alive and well at five years. The TAVR group had fewer cases of atrial fibrillation and superior hemodynamic performance, although pacemaker implantation was more common and paravalvular regurgitation occurred more frequently in this group.
TAVR patients also experienced a faster recovery, with most being discharged from the hospital within a few days and returning to normal activities within a week, compared to longer recovery times for SAVR patients.
The study’s findings suggest that Evolut TAVR remains a durable and effective option for low-risk patients with severe aortic stenosis, offering similar long-term outcomes to SAVR while providing the added benefits of a less invasive procedure and quicker recovery. The trial will continue to follow patients for 10 years to further assess the durability of TAVR valves compared to surgically implanted valves.