Medical device giant Medtronic (NYSE:MDT) released for the 1st time today the full 1-year results from the ADVANCE clinical trial of its CoreValve transcatheter aortic valve implantation system, touting mortality outcomes that other panelists at a presentation of the Transcatheter Cardiovascular Therapeutics symposium called "impressive."
ADVANCE researchers enrolled nearly 1,000 patients for implantation with the CoreValve TAVI system, reporting all-cause mortality of 17.9% at 1 year, compared with 4.5% at 1 month, according to results presented by University of Leipzig Heart Center’s Axel Link. The total rate of major adverse cardiac & cerebrovascular events was reported at 21.2% at 1 year, compared with 8% at 1 month.
Medtronic 1st released its 1-year ADVANCE results at last year’s TCT conference, reporting quality of life improvements among even the highest-risk patients. The study is among the largest "real world" multi-center TAVI trials available, Link said.
Procedural outcomes showed a 98.7% rate of correct device positioning and nearly 98% freedom from aortic regurgitation classed 3 or higher, as determined by angiography.
The ADVANCE trial, which included 44 clinical centers around the world, followed about 800 patients out to 1 year of follow-up, after losing around 200 to study withdrawals or death. Researchers posted a 1-year stroke rate of 4.5%, heart attack rate of 0.9% heart attack rate and need for emergent cardiac surgery or percutaneous re-intervention at 1.6%, according to Link.
Medtronic plans this week to unveil a highly anticipated 1st look at data from its U.S. CoreValve pivotal trial.