Medtronic (NYSE:MDT) today touted two-year outcomes for a trial comparing its Evolut TAVR system to open-heart surgery in younger people.
Fridley, Minn.-based Medtronic’s Evolut transcatheter aortic valve replacement (TAVR) system went up against the gold standard of open-heart surgery in younger, healthier aortic stenosis patients in the trial, which had its results presented as a late-breaking clinical trial at the EuroPCR 2021 e-Course, according to a news release.
Results of the landmark Evolut Low-Risk Trial showed that Evolut TAVR was non-inferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at two years (4.3% in TAVR against 6.3% in surgery). It also trended the same or lower on all critical events observed in the study.
“We know that TAVR has an advantage over surgery in certain near-term outcomes; however, in these low-risk studies, longer term outcomes are more important than ever. The full two-year data from the randomized Evolut Low Risk Trial demonstrate that between years one and two, patients who have undergone TAVR continue to do exceptionally well with no convergence of the primary outcome curves,” Yale School of Medicine director of interventional cardiology & principal investigators for the trial Dr. John Forrest said in the release. “Heart teams can be confident that low-risk patients who undergo TAVR are doing exceptionally well at two years. There are some clear differences in secondary outcomes, and the long-term impact in areas such as hemodynamics, pacemakers, and prosthesis-patient mismatch will be important to follow.”
The trial results demonstrated that, at two years, there was no convergence of the divergent Kaplan-Meier curves for death or disabling stroke between TAVR and surgery, with TAVR proving to sustain improved safety over time.
Additionally, Evolut TAVR demonstrated strong hemodynamic performance with statistically significant lower mean aortic valve gradient and larger effective orifice area compared to surgery at two years, while there were fewer deaths (3.5% vs. 4.4%), heart failure hospitalization (5.3% vs. 7.1%) and disabling stroke (1.5% vs. 2.7%) compared to surgery at two years.
The global, randomized trial evaluated the CoreValve, Evolut R and Evolut Pro valves from Medtronic, using a variety of valve sises in more than 700 patients with severe aortic stenosis deemed to have a low mortality risk with surgery with a predicted risk of mortality totaling less than 3%.
“Results from this landmark study reassure us that the positive outcomes presented using the Bayesian statistical analysis at ACC.19, before the full two-year outcomes were available, matched the actual two-year outcomes and thus was an extremely accurate and scientifically rigorous methodology that researchers can feel confident about moving forward,” Medtronic VP & CMO for its coronary & renal denervation business and the structural heart & aortic business Dr. Jeffrey J. Popma said in the release. “Furthermore, the Evolut TAVR platform continues to show it is a treatment option well-suited for lower-risk patients who are living longer and may be more active.”