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Highlights
- Evolut TAVR demonstrated significantly lower rates of bioprosthetic valve dysfunction (BVD) compared to SAPIEN at two years.
- Patients treated with Evolut TAVR experienced 5 times less prosthetic valve thrombosis and 9 times less structural valve dysfunction.
- The SMART Trial, the largest of its kind, enrolled 87% women across more than 80 global sites, with follow-ups continuing to five years.
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, has released the two-year results of the SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial — the largest international head-to-head study comparing transfemoral transcatheter aortic valve replacement (TAVR) devices. The results, presented at the Cardiovascular Research Technologies (CRT) 2025 conference in Washington, D.C., reveal that Medtronic’s Evolut™ TAVR delivers superior valve performance and significantly reduces valve-related complications compared to the SAPIEN™ valve, particularly in patients with small aortic annuli.
Superior Valve Performance and Reduced Complications
The SMART Trial data showed that Evolut TAVR consistently outperformed SAPIEN in critical areas of valve function and patient outcomes. Notably, Evolut TAVR was associated with:
- 5 times lower risk of prosthetic valve thrombosis (p=0.0048)
- 9 times lower incidence of hemodynamic structural valve dysfunction (mean gradient ≥ 20mmHg; p<0.001)
These findings underscore the potential of Evolut TAVR to mitigate adverse outcomes, as BVD is a known predictor of long-term complications in aortic stenosis patients.
A Patient-Centric Approach to Clinical Research
The SMART Trial is a landmark study not only for its size — enrolling 716 patients across 80+ international sites — but also for its focus on a population historically underrepresented in clinical research. 87% of participants were women, a group more likely to have small aortic annuli and face unique treatment challenges. Eligible patients had an aortic valve annulus area of ≤430 mm², confirmed via CT imaging, and were randomized 1:1 to receive either an Evolut PRO/PRO+/FX or a SAPIEN 3™/3 Ultra™ valve.
Looking Ahead: Long-Term Impact and Ongoing Research
While the two-year results are promising, the SMART Trial will continue to follow patients for up to five years to provide deeper insights into the long-term safety and durability of TAVR devices. Additional analyses, including pooled data on Evolut’s BVD performance in both small and large annulus patients, are set to be published in the Journal of the American College of Cardiology.
