Medtronic today released the three-year results of the SMall Annuli Randomized To Evolut or Sapien (SMART) trial, the largest international head-to-head comparative trial of transcatheter aortic valve implanation (TAVI). In patients with aortic stenosis (AS) and a small aortic annulus, results showed all individual and composite haemodynamic measures continue to be superior at three years for Evolut TAVR compared to Sapien (Edwards Lifesciences). The findings were presented at EuroPCR 2026 (19–22 May, Paris, France).
“The continued superior haemodynamic outcomes demonstrated at three years provide important evidence of Evolut TAVR’s advantage in treating patients with aortic stenosis and a small aortic annulus,” said Howard C Herrmann (University of Pennsylvania Perelman School of Medicine, Pennsylvania, USA), lead investigator of the trial.
“Additionally, these findings deliver new insights, including lower rates of valve thrombosis with Evolut. Clinical valve thrombosis is a serious complication that can drive rising gradients, valve dysfunction, and heart failure symptoms, and can often necessitate anticoagulation or repeat intervention, with added bleeding risk and long-term management burden. It is encouraging to see durable differences in haemodynamic performance through three years, with continued follow-up planned through five years,” Herrmann continued.
The SMART trial is an international, prospective, multicentre, randomised (1:1) post-market trial comparing the safety and performance of Evolut self-expanding TAVR versus Sapien balloon-expandable TAVR in patients with symptomatic severe AS and small aortic annulus.
The trial, the largest head-to-head randomised control trial to primarily enrol women, randomised and treated 716 patients, 87% of which were women, across more than 80 sites worldwide. Eligible patients had an aortic valve annulus area of ≤430 mm2 as measured by computed tomography, and suitable anatomy for 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 five years.
The SMART three-year data demonstrated that Evolut TAVR provides strong outcomes compared to Sapien TAVR. The data showed significantly lower bioprosthetic valve dysfunction (BVD) (16.3% vs. 54.4%, p<0.001), while thrombosis rate continued to be higher with Sapien (Kaplan-Meier rates VARC-2: 5.8% vs. 1.3%, p=0.002, VARC-3: 6.8% vs. 1.3%, p<0.001)
In an exploratory analysis, patients with less than or equal to moderate prosthesis-patient mismatch (PPM) experienced 2.24x cardiovascular mortality risk in SMART trial through three years (p=0.014). Moderate or greater PPM outcomes at 30 days as defined by VARC-3 were: (9.9% Evolut vs. 33.2% Sapien, p<0.001).
Similar safety profile for the clinical outcome composite of death, disabling stroke, or heart failure rehospitalisation through three years of follow-up—supporting the long-term durability and risk-benefit profile while reinforcing confidence in sustained patient outcomes.
“Outcomes from the SMART Trial continue to build on the clinical evidence supporting the safety and performance of Evolut TAVR,” said Kendra J Grubb, vice president and chief medical officer, Structural Heart, which is part of the cardiovascular portfolio at Medtronic. “These latest findings further suggest the potential for improved long-term outcomes for patients with small aortic valve annuli, including women, and reinforce the role of Evolut TAVR in enabling more individualised treatment approaches that may help inform the future of valve care.”
