PHILADELPHIA— Physicians at Penn Medicine have completed the first procedure in the Small Annuli Randomized to Evolut™ or Sapien (SMART) post-market trial, a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (AS).
The SMART trial compares valve safety and performance of the self-expanding Medtronic Evolut™ PRO and PRO+TAVR Systems with the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves manufactured by Edwards Lifesciences. The study will enroll approximately 700 patients at more than 90 international sites, and is being led Howard C. Herrmann, MD, 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. Herrmann and Pavan Atluri, MD, 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 TAVR market. Due to its focus on small annulus patients, the SMART Trial will enroll predominantly women, which will provide important clinical insight into a currently underrepresented patient population in the TAVR 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 TAVR procedure uses a catheter — inserted through a small incision in the groin or in the left side of the chest — to place a new aortic valve where the patient's native valve was, pushing the faulty valve aside. Today, Penn Medicine performs more than 500 TAVR procedures each year, improving quality of life for patients suffering from severe aortic stenosis symptoms like chest pain, shortness of breath, fainting and fatigue. Without treatment, more than half of severe aortic stenosis patients die within two years.
The start of the new trial marks another "first" in Penn's history of innovation in this space, which includes nearly 15 years of TAVR expertise and collaboration between interventional cardiology and cardiac surgery. Researchers at the Perelman School of Medicine at the University of Pennsylvania were among the leaders of early TAVR trials and remain on the cutting edge of TAVR technology, which now allows a broader range of patients to undergo the procedure. TAVR was approved by the U.S. Food and Drug Administration in 2011, following trials among patients initially who would not have been eligible for traditional open-heart surgery due to their age or other medical conditions.
"Valve design (hemodynamics) are important in order to provide patients with the most optimal valve function in the short term, as well as to contribute to long term valve performance and durability," Herrmann said.
The SMART Trial includes pre-specified endpoints of hemodynamic (blood flow) superiority and clinical non-inferiority with the Evolut platform compared to Sapien for mortality, stroke, or rehospitalization at 12 months. The results from the head-to-head study will provide evidence to help heart teams more selectively tailor valve selection.
