ACC 2017 Roundup: Medtronic’s CoreValve as good as surgery in intermediate-risk trial

The team at MassDevice.com and Drug Delivery Business News will be updating this post periodically as new comes out of ACC 2017, the annual American College of Cardiology meeting in Washington March 17-19.

Medtronic’s CoreValve as good as surgery in intermediate-risk trial

A study comparing surgical valve replacement with transcatheter aortic valve replacement using the CoreValve device made by Medtronic (NYSE:MDT) showed that the TAVR device was as safe as surgery in intermediate-risk patients, according to data presented today at ACC 2017.

Two-year data from the 1,657-patient Surtavi study, presented at ACC 2017 and published in the New England Journal of Medicine, showed non-inferiority for the CoreValve implant for an endpoint combining all-cause mortality and disabling stroke, with the TAVR device showing a 12.6% rate compared with 14% for surgical intervention. The rate of death was 11.4% for TAVR and 11.6% for surgery; the rate of disabling stroke was 2.6% for the TAVR cohort and 4.5% for the control group.

The TAVR arm of the trial was split between 2 Medtronic devices: 84% of patients received the CoreValve and 16% the 2nd-generation CoreValve Evolut.

“These are excellent, outstanding results,” said co-principal investigator Dr. Michael Reardon, of the Houston Methodist Debakey Heart & Vascular Center, who presented the data at ACC. “I believe this will lead to rapid approval by the FDA for CoreValve and Evolut in intermediate-risk patients.

“This was the lowest surgical mortality we’ve seen in a randomized trial,” he explained. “And TAVR did just as well.”

“On every new trial we do, the difference between surgery and TAVR gets smaller and smaller and smaller,” Reardon told heartwire from Medscape.

“This is a landmark trial demonstrating our commitment to generating clinical evidence to support the expansion of global patient access to life-changing therapies such as TAVR,” added heart valve therapies GM Rhonda Robb. “We are delighted to have met the primary endpoint in the Surtavi trial, the results of which have been submitted to the FDA to support an intermediate-risk label expansion.”

Material from Reuters was used in this report.

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