The late-breaking SMART trial presented at ACC.24, the annual meeting of American College of Cardiology, provided new insights for choosing the right transcatheter aortic valve replcementent (TAVR) valve in patients with a small annulus. The trial represented a head-to-head comparison of the self-expanding Evolut valves from Medtronic and the balloon-expandable Sapien 3 valves from Edwards Lifesciences.
Initial Cardiovascular Business coverage of the SMART trial is available here. To learn more, we spoke to principal investigator Howard C. Herrmann, MD, a professor at the Perelman School of Medicine at the University of Pennsylvania and section chief for interventional cardiology at the Hospital of the University of Pennsylvania, for an exclusive interview.
Key takeaways from the SMART trial:
• There was no statistical difference between the devices in the first primary endpoint, which was a composite of mortality, disabling stroke, heart failure and rehospitalization.
• There was a difference favoring the Evolut in the second primary endpoint, which looked at valve performance using a composite of bioprosthetic valve dysfunction, structural valve dysfunction, non-structural valve dysfunction, severe prosthesis patient mismatch, aortic insufficiency, thrombosis, endocarditis and aortic valve reintervention.
• Evolut was favored in five different pre-specified secondary endpoints, which included the mean gradient, effective orifice area, prosthesis-patient mismatch, hemodynamic structural valve dysfunction and bioprosthetic valve dysfunction in women.
"That endpoint occurred in 42% of the balloon-expandable valves and only 9% of the self-expanding valves. So a difference of more than 30%, meeting the superiority endpoint P value for superiority of the self-expanding valves. And then because we met both primary endpoints, we proceeded with hierarchical testing of five different pre-specified secondary endpoints. In every case, the self-expanding valve was found to be superior," Herrmann explained.
Disclosures: Herrmann reports receiving institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic and consultant fees from Abbott, Edwards Lifesciences and Medtronic. Please see the study for all other authors’ relevant financial disclosures.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com