TAVR Equal to Surgery in Low-Risk Patients with Severe Aortic Stenosis | ACC 2025

People who have severe aortic stenosis but who have a low risk of mortality from surgery do just as well with transcatheter aortic valve replacement (TAVR) as they do with the surgical approach, although the less invasive procedure did provide some slight advantages over a five-year period, results of a randomized clinical trial demonstrated.

The results were presented at the American College of Cardiology Annual Scientific Session and Expo and published in JACC.

Severe aortic stenosis is a disease where the valve is narrowed, and this reduces or blocks blood flow from the heart. Standard treatment involves replacing the aortic valve. This can be done through surgery or through a transcatheter, which is a minimally invasive procedure done with a catheter through a blood vessel in the groin or the chest.

Researchers in the Evolut Low Risk Trial wanted to evaluate the five-year outcomes of transcatheter aortic valve replacement using one of Medtronic’s Evolut TAVR systems compared with surgery.

They found that at five years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke. Valve durability and performance were also good.

Michael Reardon, M.D.

The trial enrolled 1,414 patients with severe aortic valve stenosis who had an estimated risk of surgical mortality of 3% or less and with an anatomy that was suitable for both TAVR and surgery, randomizing them to either approach on a 1:1 basis, said Michael Reardon, M.D., chair of cardiovascular research at Houston Methodist DeBakey Heart and Vascular Center. Reardon presented the results at a late-breaking session.

Patients in the TAVR arm received the CoreValve, Evolut R or Evolut PRO. The operations were performed between March 2016 and May 2019.

At five years, the rate of all-cause mortality or disabling stroke was 16.4% for the surgery patients and 15.5% for TAVR, Dr. Reardon said. When broken out separately, the rate for disabling stroke was 4% for surgery vs. 3.6% for TAVR; the rate for all-cause mortality was 14.9% vs. 13.5%.

The five-year noncardiovascular mortality rates were 6.2% for surgery and 6.8% for TAVR, while the cardiovascular mortality rates were 9.3% vs 7.2%. Dr. Reardon noted that the gap between the two groups in the latter measure widened from 1.1% at two years to 2.1% at five years.

There were differences in some secondary endpoints, including better hemodynamics as well as a lower rate of atrial fibrillation in the TAVR group. Patients who underwent surgery had a lower rate of new pacemaker placement and less mild paravalvular regurgitation. At five years there was no significant difference in the rate of aortic valve rehospitalization, endocarditis, myocardial infarction, reintervention, or valve thrombosis between groups.

“You combine all this data; this gives us great confidence that the results of this trial at five years support Evolut as a safe, effective, and durable alternative to surgery for patients with severe aortic stenosis and a low surgical risk in populations similar to the one we tested,” Dr. Reardon said.

The trial was funded by Medtronic. Dr. Reardon has received research grants from Abbott, Boston Scientific, WL Gore Medical, and Medtronic.