High-risk data for Medtronic’s CoreValve
Medtronic (NYSE:MDT) said data from a U.S. pivotal trial of its CoreValve transcatheter aortic valve implant showed superiority to surgical valve replacement at 3 years and at 2 years in patients with a mortality risk of less than 7%.
The trial tracked 407 high-risk patients for 3 years, with a combined endpoint of all-cause mortality or stroke of 37.3% for the CoreValve arm, compared with 46.7% for the surgical arm. The rate of all stroke was 12.6% for CoreValve patients and 19.0% for the surgical patients; all-cause mortality was 32.9% for CoreValve compared with 39.1% for surgery.
“It’s reassuring to see that the CoreValve high risk Study continues to show that TAVR is superior to surgery at 3 years for the combined endpoint of mortality and stroke, which has the most important impact on patients,” Dr. Michael Deeb, of the University of Michigan Frankel Cardiovascular Center, said in prepared remarks. “Most importantly, the new data supports the viability of TAVR out to 3 years with no signal of a significant increase in mean gradient or aortic regurgitation.”
A subgroup of 383 patients with an STS predicted risk of mortality estimate of less than 7% showed that the rate of all-cause mortality for the CoreValve arm was 15.0% compared with 26.3% for the surgical cohort. Rates of combined all-cause mortality or major stroke were 17.1% for the TAVR group and 31.9% for the surgical group.
“It was encouraging to see that CoreValve patients with lower STS mortality risk scores within the high risk study achieved a superior survival benefit relative to surgery, as did all patients in the study at 2 years. The survival advantage compared to surgery appeared to widen between year 1 and year 2, reinforcing the notion that the CoreValve system is a viable treatment solution for patients with severe aortic stenosis at high risk,” said Dr. Michael Reardon of the Houston Methodist DeBakey Heart & Vascular Center. Read more