Newly released two-year data from Medtronic’s SMART trial highlights the ongoing superior valve performance of the Evolut TAVR system in patients with a small aortic annulus.
SMART expands to SMall Annuli Randomized To Evolut or SAPIEN. This global head-to-head study focused on transfemoral transcatheter aortic valve replacement (TAVR).
The study’s aim is to provide critical insights into the long-term benefits of Evolut over its competitor, Edwards Lifesciences’ SAPIEN, particularly in managing aortic stenosis with smaller annular sizes.
Data from the SMART trial revealed that both systems showed comparable results in terms of mortality, disabling stroke, and heart failure hospitalisation. However, the Evolut TAVR system stood out for its reduced incidence of bioprosthetic valve dysfunction (BVD), said Medtronic.
BVD is known to be associated with adverse patient outcomes.
Further analysis from the SMART trial underscored Evolut’s advantage in reducing prosthetic valve thrombosis and haemodynamic structural valve dysfunction when compared to SAPIEN. These particular findings strengthen the case for Evolut’s performance in offering longer-lasting solutions for small annulus patients, according to Medtronic.
Howard Herrmann from the Perelman School of Medicine at the University of Pennsylvania is the lead investigator of the trial.
Herrmann said: “Valve performance is critical for all patients, but the impact of poor valve performance is magnified in patients with a small aortic annulus, who are at risk of receiving a valve that is not adequate for their cardiac requirements.
“The two-year results highlight the continued superior performance of the Evolut TAVR valve in these patients.
“While we would not yet expect to see a significant difference in the composite clinical outcomes at this early stage, valve performance provides important data that operators can use to inform and personalise treatment decisions to enhance patient outcomes.”
The trial compared the Evolut self-expanding TAVR with the SAPIEN balloon-expandable option in 716 participants at over 80 sites around the world, focusing on patients with small annuli. The participant group was predominantly female, with women making up 87% of those enrolled.
Eligible patients had an aortic valve annulus area of up to 430mm² as measured by computed tomography. Both Evolut PRO/PRO+/FX and SAPIEN 3/3 Ultra valves were evaluated for suitability in transfemoral TAVR procedures.
The study continues to monitor these patients over five years, aiming to provide further insights into long-term efficacy and safety.
