Sam Brusco, Associate Editor04.08.24
Medtronic announced new data from its SMART trial, the largest head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (TAVR). The data was presented at the American College of Cardiology Annual Scientific Session and simultaneously published in The New England Journal of Medicine.
One-year results of the SMall Annuli Randomized To Evolut or Sapien (SMART) trial in individuals with aortic stenosis (AS) with small aortic annuli (SAA) showed noninferior clinical outcomes and superior valve performance as measured by bioprosthetic valve dysfunction performance for the Evolut TAVR platform compared to Edwards Lifesciences’ Sapien platform.
The trial randomized and treated 716 patients, 87% of which were women, across over 80 sites worldwide. Eligible patients had a computed tomography aortic valve annulus area of ≤430 mm2 and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a Sapien 3/3 Ultra valve.
Evolut TAVR met non-inferiority for the clinical outcome primary endpoint, a composite of all-cause mortality, disabling stroke, or heart failure rehospitalization at one year (9.4% Evolut vs. 10.6% Sapien, p<0.001 for non-inferiority). It also demonstrated superiority for the valve function primary endpoint, bioprosthetic valve dysfunction through one year (9.4% Evolut vs. 41.6% Sapien, p<0.001 for superiority).
"SMART was launched to better understand how the two most commonly used TAVR systems perform in patients with small aortic annuli, and particularly in women who tend to have smaller heart valves," said Nina Goodheart, senior VP and president, of Medtronic's Structural Heart & Aortic business. "We continue to develop evidence to better understand the benefits of our Evolut TAVR technology in all patients, including patient populations that are underrepresented, under-diagnosed and under-treated. The results from the SMART trial demonstrate these benefits in a large patient population and reinforce our commitment to driving health equity and engineering the best technology to solve unmet patient needs."
Last month, Medtronic earned U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ TAVR system to treat severe, symptomatic aortic stenosis.
One-year results of the SMall Annuli Randomized To Evolut or Sapien (SMART) trial in individuals with aortic stenosis (AS) with small aortic annuli (SAA) showed noninferior clinical outcomes and superior valve performance as measured by bioprosthetic valve dysfunction performance for the Evolut TAVR platform compared to Edwards Lifesciences’ Sapien platform.
The trial randomized and treated 716 patients, 87% of which were women, across over 80 sites worldwide. Eligible patients had a computed tomography aortic valve annulus area of ≤430 mm2 and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a Sapien 3/3 Ultra valve.
Evolut TAVR met non-inferiority for the clinical outcome primary endpoint, a composite of all-cause mortality, disabling stroke, or heart failure rehospitalization at one year (9.4% Evolut vs. 10.6% Sapien, p<0.001 for non-inferiority). It also demonstrated superiority for the valve function primary endpoint, bioprosthetic valve dysfunction through one year (9.4% Evolut vs. 41.6% Sapien, p<0.001 for superiority).
"SMART was launched to better understand how the two most commonly used TAVR systems perform in patients with small aortic annuli, and particularly in women who tend to have smaller heart valves," said Nina Goodheart, senior VP and president, of Medtronic's Structural Heart & Aortic business. "We continue to develop evidence to better understand the benefits of our Evolut TAVR technology in all patients, including patient populations that are underrepresented, under-diagnosed and under-treated. The results from the SMART trial demonstrate these benefits in a large patient population and reinforce our commitment to driving health equity and engineering the best technology to solve unmet patient needs."
Last month, Medtronic earned U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ TAVR system to treat severe, symptomatic aortic stenosis.