SMART Evaluates Medtronic’s Evolut TAVR to Treat Symptomatic Aortic Stenosis and Small Aortic Annulus

May 26, 2026—Medtronic announced 3-year results of the SMART international head-to-head comparative trial of transcatheter aortic valve replacement (TAVR) with the company’s Evolut self-expanding system versus the Sapien balloon-expandable system (Edwards) to treat patients with symptomatic aortic stenosis and a small aortic annulus.

According to the company, the trial showed that all individual and composite hemodynamic measures continue to be superior at 3 years for Evolut TAVR compared to Sapien TAVR. The findings were presented at EuroPCR 2026 in Paris, France. Howard C. Herrmann, MD, is lead investigator of the SMART trial.

As summarized in Medtronic’s press release, the trial randomized (1:1) 716 patients (women, 87%) across more than 80 sites worldwide. Eligible patients had an aortic valve annulus area of ≤ 430 mm² (as measured by CT) and suitable anatomy for treatment by transfemoral TAVR with both an Evolut Pro/Pro+/FX or a Sapien 3/3 Ultra valve. Patients enrolled in the trial will continue to be followed out to 5 years.

Medtronic reported that the 3-year SMART data showed significantly lower bioprosthetic valve dysfunction for Evolut than Sapien (16.3% vs 54.4%; P < .001) and the thrombosis rate continues to be higher with Sapien by Kaplan-Meier rates for VARC-2 (5.8% vs 1.3%; P = .002) and VARC-3 (6.8% vs 1.3%; P < .001).

The company further stated that in an exploratory analysis, patients with moderate or greater prosthesis-patient mismatch (PPM) experienced a 2.24x cardiovascular mortality risk in the SMART trial through 3 years (P = .014).

Additionally, moderate or greater PPM outcomes at 30 days as defined by VARC-3 were 9.9% for Evolut versus 33.2% for Sapien (P < .001). There was a similar safety profile for the clinical outcome composite of death, disabling stroke, or heart failure rehospitalization through 3 years of follow-up.

These findings support the long-term durability and risk-benefit profile while reinforcing confidence in sustained patient outcomes, stated Medtronic.