The first procedure has been completed in SMART (Small Annuli Randomized to Evolut or Sapien) post-market trial, a randomised, head-to-head study comparing two transcatheter aortic valve implantation (TAVI) systems in patients with severe symptomatic aortic stenosis (AS).
The SMART trial compares valve safety and performance of the self-expanding Evolut PRO and PRO+TAVR systems (Medtronic) with the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (Edwards Lifesciences).
The study will enrol approximately 700 patients at more than 90 international sites, and is being led Howard C Herrmann, the John Winthrop Bryfogle Professor of Cardiovascular Diseases at the Perelman School of Medicine at the University of Pennsylvania and Health System Director for Interventional Cardiology, Philadelphia, USA. Herrmann and Pavan Atluri, an associate professor of Surgery, recently completed treatment of the first patient in the study.
The study evaluates valve performance in patients with small annuli, a small aortic valve, which represents about 30% of the global TAVI market. Due to its focus on small annulus patients, the SMART Trial will enrol predominantly women, which will provide important clinical insight into a currently underrepresented patient population in the TAVI literature.
“Penn Medicine has been in on the ground floor of many of the early and landmark trials in TAVR research since performing one of the first investigational procedures in 2007, and, since then, we have completed thousands of these procedures,” Herrmann said. “Subsequently, multiple devices have been FDA-approved, and the procedure has grown to become the predominant one for all patients with aortic stenosis. The outcome of this study will help cardiac teams to make more tailored decisions about which kind of valve to use on which patients.”
The SMART Trial includes pre-specified endpoints of haemodynamic superiority and clinical non-inferiority with the Evolut platform compared to Sapien for mortality, stroke, or rehospitalisation at 12 months.