Transcatheter aortic valve replacement (TAVR) has emerged as a transformative, minimally invasive alternative for patients with symptomatic severe aortic stenosis, irrespective of their surgical risk.¹ The extension of TAVR into low-risk populations has warranted careful evaluation, as intermediate- and long-term comparative data assessing TAVR vs. surgery in these patients remain limited.¹ At the ACC Annual Scientific Session 2025, Dr. Michael J. Reardon from Methodist DeBakey Heart and Vascular Center in the United States presented the 5-year outcomes from the Evolut Low Risk trial, comparing the Evolut TAVR system with surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and low surgical risk.¹

The multinational, prospective, randomized interventional trial enrolled over 1,400 patients with severe trileaflet aortic stenosis who were at low surgical risk (Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM score] <3%) and had anatomy suitable for both TAVR and SAVR.¹ Participants were randomized 1:1 to receive either the Evolut TAVR (n=730) or SAVR (n=684), with follow-up extending over five years.¹ The median age of participants was 74 years and nearly 65% were male.¹ Baseline characteristics were well-balanced between the TAVR and SAVR groups.¹

The study assessed the composite outcome of all-cause mortality or disabling stroke.1 At five years, the composite endpoint occurred in 15.5% of the TAVR group and 16.4% of the SAVR group (HR=0.90; 95% CI: 0.69-1.18; p=0.47).¹ Individually, all-cause mortality was 13.5% for TAVR and 14.9% for SAVR (p=0.39), while disabling stroke rates remained low and comparable, occurring in 3.6% of TAVR patients and 4.0% in those who underwent SAVR.¹ Cardiovascular mortality was slightly lower in the TAVR group at 7.2% compared to 9.3% for SAVR, reflecting an absolute difference of 2.1% favoring TAVR at five years, although this difference did not reach statistical significance (HR=0.75; p=0.15).¹

The study also evaluated rates of pacemaker implantation and atrial fibrillation—known risks associated with valve procedures.¹ Atrial fibrillation was significantly more frequent in the surgical group (41.2% vs. 16.3%; p<0.001).¹ In contrast, new pacemaker implantation occurred more often in patients undergoing TAVR (27.0% vs 11.3%; p<0.001).¹ Beyond mortality and stroke, the Evolut valve treatment group demonstrated favorable hemodynamic performance over time, with significantly lower mean gradients and larger effective orifice areas (EOAs) than surgical valves (p<0.001 for both).¹ Importantly, reintervention rates were low and comparable between the two groups, occurring in 3.3% of Evolut TAVR patients and 2.5% of those undergoing surgery (p=0.44).¹ Similarly, rates of moderate or greater paravalvular regurgitation (PVR) were infrequent and not significantly different, observed in 0.4% of TAVR patients vs. 0.5% in the surgical group (p=0.50).¹

Notably, the proportion of patients considered “alive and well” (Kansas City Cardiomyopathy Questionnaire [KCCQ] scores >75) at five years was similar across both groups, highlighting the comparable quality-of-life outcomes in both treatment approaches.¹ Both groups maintained favorable functional status at five years, with only 2.3% of TAVR and 2.8% of SAVR patients in New York Heart Association Functional (NYHA) class III or IV.¹

In conclusion, TAVR with the Evolut system is a safe, effective, and durable alternative to surgery for patients with severe aortic stenosis who are at low surgical risk.¹ The Evolut platform also provided sustained hemodynamic and functional benefits.¹ These five-year findings from the Evolut Low Risk trial provide compelling evidence to support the expanded use of TAVR in patients with severe aortic stenosis with low surgical risk.¹