Medtronic’s Evolut TAVR System Compared to Surgery in Low-Risk Patients at 2-Years

May 18, 2021—Medtronic announced the complete 2-year outcomes from the landmark Evolut Low Risk trial comparing the company’s Evolut transcatheter aortic valve replacement (TAVR) system to open-heart surgery in characteristically younger, healthier aortic stenosis patients. The findings were presented at the virtual EuroPCR 2021 conference.

According to the company, the results showed the Evolut TAVR platform was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years (4.3%, TAVR vs 6.3%, surgery; P < .0001 for noninferiority), and trended the same or lower on all critical events, confirming the earlier Bayesian statistical analysis presented at the American College of Cardiology’s 68th annual scientific session in 2019.

At 2 years, results from the study showed there was no convergence of the divergent Kaplan-Meier curves for death or disabling stroke between TAVR and surgery, demonstrating that improved safety shown early on for TAVR was sustained over time.

In addition, the company reported that the results from the study at 2 years for TAVR versus surgery showed:

• Excellent hemodynamic performance with statistically significantly lower mean aortic valve gradient (9 vs 11.7 mm Hg) and larger effective orifice area than surgery (2.2 vs 2 cm²) at 2 years, (P < .001 for both comparisons)
• Numerically lower rates of death (3.5% vs 4.4%), heart failure hospitalizations (5.3% vs 7.1%) and disabling stroke (1.5% vs 2.7%)
• Lower prosthesis-patient mismatch with a difference of 2.1% versus 4.9% in the severe category (P < .001)
• No increase of valve thrombosis rates, which remained low (0.3% vs 0.2%)

“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,” commented John Forrest, MD, Principal Investigator of the Evolut Low Risk trial, in the company’s announcement. “The full 2-year data from the randomized Evolut Low Risk trial demonstrate that between years 1 and 2, patients who have undergone TAVR continue to do exceptionally well with no convergence of the primary outcome curves.

“Heart teams can be confident that low-risk patients who undergo TAVR are doing exceptionally well at 2 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 global randomized Evolut Low Risk Trial evaluated three valve generations (CoreValve, Evolut R, and Evolut Pro valves) across a variety of valve sizes in > 700 patients with severe aortic stenosis deemed to have a low mortality risk with surgery with a predicted risk of mortality of < 3%.

The Evolut TAVR platform, which includes the Evolut R, Evolut Pro, and Evolut Pro+ TAVR systems, is indicated for symptomatic patients with severe aortic stenosis across all surgical risk categories (extreme, high, intermediate, and low) in the United States and countries that recognize CE Mark, advised Medtronic.