SMART Trial shows ongoing superior valve performance for Evolut at two-year mark
Medtronic plc recently disclosed the two-year results of the significant SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial. This trial is recognized as the most comprehensive international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (TAVR). The study aimed to evaluate patients with aortic stenosis and a small aortic annulus, indicating similar outcomes in terms of composite metrics like mortality, disabling stroke, and heart failure hospitalization over a two-year period. The results underscored the superior performance of the Evolut™ TAVR system compared to the SAPIEN™ system, particularly in terms of bioprosthetic valve dysfunction (BVD).
Dr. Howard C. Herrmann from the Perelman School of Medicine at the University of Pennsylvania, who led the investigation, emphasized the critical importance of valve performance in patients, especially those with small aortic annuli. He highlighted that patients with a small aortic annulus are at higher risk of receiving an inadequate valve, making valve performance a crucial factor for optimal patient outcomes. Dr. Herrmann noted that the two-year data signifies the continued superiority of the Evolut TAVR system in these patients, providing essential information for healthcare providers to make personalized treatment decisions and enhance patient care.
The study results from SMART trial’s two-year data revealed that the Evolut TAVR system displayed significantly lower bioprosthetic valve dysfunction compared to the SAPIEN system. Remarkably, Evolut TAVR exhibited five times less prosthetic valve thrombosis and nine times less hemodynamic structural valve dysfunction compared to the SAPIEN TAVR system. These findings complement other data demonstrating the impressive performance of Evolut TAVR in patients with small and large annuli. Additionally, Dr. Steven Yakobuv’s pooled analysis published in the Journal of the American College of Cardiology further supports the superiority of the Evolut TAVR system.
The SMART Trial, a large post-market randomized controlled trial conducted across various international sites, focused on comparing the safety and performance of the Evolut TAVR system with the SAPIEN TAVR system in patients suffering from symptomatic severe aortic stenosis and small aortic annulus. This trial, which predominantly enrolled women, successfully treated 716 patients globally, with 87% of them being women. Eligible patients with an aortic valve annulus area of ≤430 mm underwent the TAVR procedure and will continue to be monitored for up to five years to assess long-term outcomes.
Dr. Kendra J. Grubb, vice president and chief medical officer of Structural Heart, emphasized the groundbreaking nature of the SMART Trial, highlighting how Evolut’s distinct valve design benefits patients with small annuli. Continued monitoring over two years has reinforced the superior valve performance that will be further assessed for long-term outcomes. Aortic stenosis, characterized by the narrowing of the aortic valve, affects a significant number of individuals globally, underscoring the importance of tailored valve selection for patients with small aortic annuli.
Medtronic plc, based in Galway, Ireland, is a leading global healthcare technology company dedicated to tackling the most challenging health issues worldwide. Their bold mission to alleviate pain, restore health, and extend life guides their operations, offering innovative technologies and therapies for various health conditions. With a team of over 95,000 individuals across 150 countries, Medtronic remains committed to transforming lives through cutting-edge technologies that prioritize patient well-being and outcomes. Expect more from Medtronic as they continue to revolutionize healthcare with insightful care solutions and better outcomes for the global population.
