CoreValve Beats Traditional Valve Replacement in Trial

Medtronic has announced the results of two studies testing its CoreValve transcatheter aortic valve replacement product, which were presented at the American College of Cardiology's 63rd Annual Scientific Session in Washington, DC.

The High Risk Study of the CoreValve US Pivotal Trial met its primary endpoint with a low one-year, all-cause mortality rate of only 14.2 percent in patients receiving the CoreValve System, compared to 19.1 percent in patients receiving surgical aortic valve replacement (SAVR). "We're making continual progress. It's not only an alternative but may be a preferable alternative [to open heart surgery]," said David Adams, MD, a co-principal investigator in the study in an interview with Reuters.

Final four-year follow-up results from the CoreValve CE Pivotal Study, which demonstrated excellent long-term durability in patients with severe aortic stenosis who were treated with the CoreValve System, were also announced.

The CoreValve High Risk Study, simultaneously published in The New England Journal of Medicine, showed that the CoreValve System is superior to SAVR in patients with severe aortic stenosis who are considered high risk for surgery.

Medtronic says this is the first and only study to show the superiority of a transcatheter aortic valve over conventional surgery. Its CoreValve System met its primary study endpoint with higher than expected survival. All-cause mortality at one year was only 14.2% in patients receiving the CoreValve System, versus 19.1% in patients receiving SAVR. This difference calculates to be a 26% decrease in mortality risk.

Major stroke rates in patients who received the CoreValve System were 3.9% at 30 days and 5.8% at one year, versus 3.1% at 30 days and 7.0% at one year for patients who received SAVR. Medtronic says these stroke rates were low and not statistically different. This finding is said to be important because stroke is one of the complications most concerning to physicians and patients because it increases mortality and affects quality of life.

Stephen Levy is a contributor to Qmed and MPMN.