Medtronic two-year evolut low-risk TAVR trial results released

Medtronic plc released complete two-year outcomes from its Evolut Low Risk Trial, comparing its minimally-invasive Evolut transcatheter aortic valve replacement (TAVR) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients.

Results proved the Evolut TAVR platform non-inferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at two years (4.3 percent for TAVR versus 6.3 percent for surgery; p< 0.0001 for non-inferiority), and trended the same or lower on all critical events.

“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,” John Forrest, M.D., director of interventional cardiology at the Yale School of Medicine and principal Evolut Low Risk Trial investigator told the press. “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.”

At two years, study results demonstrated no convergence of the divergent Kaplan-Meier curves for death or disabling stroke between TAVR and surgery, showing improved safety early on for TAVR was sustained over time. Results also showed:

• Excellent hemodynamic performance for TAVR with statistically significantly lower mean aortic valve gradient (9.0 mm Hg versus 11.7 mm Hg) and larger effective orifice area than surgery (2.2 cm2 versus 2.0 cm2) at two years, (p < 0.001 for both comparisons).
• Numerically lower rates of death in the TAVR arm (3.5 percent versus 4.4 percent), heart failure hospitalizations (5.3 versus 7.1 percent) and disabling stroke (1.5 versus 2.7 percent) compared to surgery at two years.
• Prosthesis-patient mismatch was lower for TAVR compared to surgery at two years with a difference of 2.1 percent versus 4.9 percent in the severe category (p<0.001).
• Valve thrombosis rates showed no signs of increase and remained low at two years (0.3 percent for TAVR versus 0.2 percent for SAVR).

The global randomized Evolut Low Risk Trial evaluated CoreValve, Evolut R, and Evolut PRO valves across a variety of valve sizes in over 700 patients with severe aortic stenosis with low mortality risk for surgery with a predicted mortality risk of less than 3 percent.

“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,” said Jeffrey J. Popma, M.D., vice president and chief medical officer for Medtronic’s Coronary & Renal Denervation and Structural Heart & Aortic businesses. “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.”

The Evolut TAVR platform is indicated for symptomatic patients with severe aortic stenosis across all surgical risk categories in the U.S. and countries that recognize CE mark. It is estimated 165,000 low-risk patients suffer from severe aortic stenosis per year in the U.S., Western Europe, and Japan. If left untreated, it can cause heart failure in as little as two years. MPO Mag