Evolut TAVR Demonstrates Continued Advantage in Small Aortic Annulus Patients
Medtronic’s SMART Trial has released its two-year results, confirming the superior performance of the Evolut TAVR system over the SAPIEN TAVR device in patients with aortic stenosis and a small aortic annulus. The trial, which is the largest international head-to-head study of transfemoral TAVR, found comparable composite outcomes for mortality, disabling stroke, and heart failure hospitalizations, while showing significant advantages in valve performance.
Key findings of the trial included:
- Reduced Bioprosthetic Valve Dysfunction (BVD): Evolut TAVR exhibited significantly lower BVD, a crucial factor in predicting adverse patient outcomes.
- Lower Incidence of Prosthetic Valve Thrombosis: The Evolut device showed five times fewer cases (p=0.0048) compared to SAPIEN.
- Reduced Hemodynamic Structural Valve Dysfunction: Evolut was nine times less likely to show dysfunction as defined by a mean gradient ≥ 20mmHg (p<0.001).
These results underscore the importance of valve performance in patients with small aortic annuli, where a well-fitting valve is crucial for ensuring long-term outcomes. Dr. Howard C. Herrmann, lead investigator from the University of Pennsylvania, emphasized that while clinical outcomes are not yet significantly different at the two-year mark, the data on valve performance is valuable for clinicians in personalizing treatment plans.
The SMART Trial also stands out for its focus on women, with 87% of the trial participants being female. The trial included 716 patients from over 80 sites globally and will continue to track patient outcomes for five years.
Follow MEDWIRE.AI for more insights on advancements in cardiovascular technologies.
