medtronic released two-year results from the smart trial, the largest international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (tavr), demonstrating superior valve performance for the evolut tavr system in patients with small aortic annulus.

the study, presented at the cardiovascular research technologies (crt) 2025 conference in washington, d.c., showed that while composite clinical outcomes such as mortality, disabling stroke, and heart failure hospitalization were comparable between evolut and sapien tavr, evolut exhibited significantly lower rates of bioprosthetic valve dysfunction (bvd).

key findings from the two-year data include:
- five times lower prosthetic valve thrombosis (p=0.0048)
- nine times lower hemodynamic structural valve dysfunction (p<0.001)

dr. howard c. herrmann from the perelman school of medicine emphasized that valve performance is particularly crucial for patients with small aortic annulus, as it impacts long-term outcomes. dr. kendra j. grubb, vice president and chief medical officer for structural heart at medtronic, noted that these results reinforce evolut’s differentiated valve design and its long-term potential.

the smart trial, involving 716 patients across 80 global sites, is the largest randomized control trial to primarily enroll women (87% of participants). the study will continue to follow patients for five years to assess long-term outcomes.

source: [medtronic](https://news.medtronic.com)