The SMART trial evaluates Medtronic’s Evolut and Edwards’ Sapien transcatheter aortic valve replacement systems. It looks at the TAVR implants in individuals with aortic stenosis (AS) with small aortic annuli (SAA). The trial previously demonstrated noninferior clinical outcomes and superior valve performance, measured by bioprosthetic valve dysfunction (BVD) performance for Evolut.
Data shared by Medtronic demonstrated further that Evolut was associated with significantly less BVD, among other metrics. The company presented the latest data at the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2024.
Medtronic says SMART represents the largest comparative trial of TAVR. It also marks the largest TAVR trial to date to enroll primarily women (87%). SMART randomized and treated 637 patients across more than 80 sites worldwide.
According to Medtronic, women have both TAVR and surgical aortic valve replacement (SAVR) as AS treatment options. However, due to smaller aortic annuli, women can often receive a valve replacement that fails to properly fit their anatomy. This study helps to gather clinical evidence to inform the best treatment approaches.
“The data presented today at EuroPCR provides meaningful insights into the benefits Evolut TAVR has for women,” said Nina Goodheart, SVP and president of Medtronic’s Structural Heart & Aortic business. “This new analysis reinforces TAVR’s effectiveness as a solution for achieving superior valve performance while also highlighting the importance of clinical evidence to inform the best treatment approaches for women.”
A look at the latest TAVR data from Medtronic
Results from SMART demonstrated that primary clinical endpoint for composite of death, disabling stroke, or heart failure rehospitalization was similar amongst women with AS and small annulus randomized to balloon-expandable valve (BEV) or SEV at one year.
Compared to a BEV, Evolut led to significantly less BVD (8.4% vs. 41.8% at 12 months). It also led to less prosthesis-patient mismatch (11.1% vs. 37.4% at 12 months) and less mild or greater total aortic regurgitation (12.3% vs. 18.8% at 12 months). Medtronic reported improved quality of life in women with AS and small annulus.
“This study is a major milestone for women, who have historically been excluded and underrepresented in clinical trials,” said Dr. Roxana Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials, Mount Sinai School of Medicine and co-lead investigator of the SMART trial. “This subset of the data reinforces that compared to balloon-expandable valves, the Evolut TAVR system was associated with significantly less bioprosthetic valve dysfunction and improved quality of life in women.”
