medtronic
(New York Stock Exchange: MDT)
today announced new data from a direct trial of its heart valve technology with Edwards Lifesciences.
The SMART trial will evaluate Medtronic's Evolut and Edwards' Sapien transcatheter aortic valve replacement systems. This study examines her TAVR implant in patients with aortic stenosis (AS) with small aortic annulus (SAA). This study previously demonstrated noninferior clinical outcomes and superior valve performance as measured by Evolut's bioprosthetic valve dysfunction (BVD) performance.
Data shared by Medtronic further demonstrated that Evolut was associated with significant reductions in BVD, among other metrics. The company presented the latest data at the European Association for Percutaneous Cardiovascular Interventions (EuroPCR) 2024.
Medtronic says SMART is the largest controlled trial of TAVR. This is also the largest TAVR trial to date enrolling primarily women (87%). SMART has randomized and treated 637 of her patients at her more than 80 sites around the world.
According to Medtronic, women have both TAVR and surgical aortic valve replacement (SAVR) as treatment options for AS. However, because women have smaller aortic annulus, they often undergo valve replacement surgery that does not properly fit their anatomy. This research will help gather clinical evidence to inform the best treatment approaches.
“The data presented today at EuroPCR provides meaningful insight into the benefits that Evolut TAVR brings to women,” said Medtronic, which is part of Medtronic's cardiovascular portfolio. “This new analysis strengthens the efficacy of TAVR as a solution to achieve superior valve performance while highlighting the importance of clinical evidence to inform the best treatment approach for women.”
View the latest Medtronic TAVR data
SMART results show that the primary clinical endpoint of a composite of death, disabling stroke, or heart failure readmission was for AS and small valve annulus patients randomized to balloon-expandable valve (BEV) or SEV at 1 year. demonstrated that it was similar among women with
Compared to BEV, Evolut had a significant reduction in BVD (8.4% vs. 41.8% at 12 months). There was also a reduction in prosthesis-patient mismatch (11.1% vs. 37.4% at 12 months) and a reduction in mild or worse aortic regurgitation (12.3% vs. 18.8% at 12 months). Medtronic reported improved quality of life for 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. Mikal, professor of medicine at the Mount Sinai School of Medicine and director of cardiovascular intervention research and clinical trials, and co-principal investigator. said Dr. Roxana Mehran. She is a researcher on the SMART trial. “This subset of data confirms that the Evolut TAVR system significantly reduced bioprosthetic valve dysfunction and improved the women's quality of life compared to balloon-expandable valves.”