Medtronic (NYSE:MDT) is touting data from a pair of studies of intermediate-risk patients implanted with its Evolut R replacement heart valve, presented today at the Transcatheter Cardiovascular Therapeutics annual meeting in Denver.
Fridley, Minn.-based Medtronic presented results from its Surtavi trial and Evolut R Forward real-world study of its next-generation transcatheter aortic valve replacement today at TCT.
One-year data from Surtavi, comparing the Evolut R and CoreValve devices with open heart surgery, showed a 7.8% mortality rate for the TAVR arm, compared with 8.5% for the open surgery arm. A sub-group analysis showed a 100% survival rate and a 1.5% all-stroke rate and a 0.4% rate of disabling stroke at 30 days, the company said.
“With its supra-annular and self-expanding design, the Evolut TAVR platform is well-suited to deliver excellent valve performance for intermediate risk patients who are often considered to be more active than high- or extreme-risk patients,” Dr. Nicolas Van Mieghem, of Rotterdam’s Erasmus Medical Center, said in prepared remarks. “As new clinical data are gathered for this patient population, we continue to see the exceptional clinical benefits this self-expanding valve provides as a minimally-invasive treatment alternative to surgery.”
Another sub-analysis, of patients stratified according to predicted mortality risk of STS-PROM less than 3%, showed a 1.5% rate of all-cause mortality or disabling stroke at 1 year, compared with 6.5% for the open surgery cohort.
Results from a subset of 257 patients in the Evolut R Forward study, also stratified with an STS PROM of less than 3%, showed an all-cause mortality rate of 2.0% and a disabling stroke rate of 1.2% at 30 days.
“As we continue to build our growing body of evidence to support the Evolut TAVR platform in intermediate-risk patients, the Surtavi and Forward clinical programs further support our efforts to expand TAVR access to a broader patient population,” structural heart medical affairs VP Dr. Pieter Kappetein said. “We look forward to working with heart teams around the globe to continue our commitment to evaluating TAVR performance in healthier patients.”