CoreValve system meets endpoint in study of Aortic Stenosis - Medtronic

The CoreValve System, from Medtronic, showed results superior to surgical Aortic Valve replacement (SAVR) at one year in the High Risk Study of its CoreValve U.S. Pivotal Trial, which evaluated patients with severe Aortic Stenosis who are considered high risk for surgery. The head-to-head study 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 SAVR at one year. The CoreValve High Risk Study is the first prospective, randomized study to show any transcatheter aortic valve to be superior to surgery.

Stroke rates in patients with the CoreValve System were low and not statistically different than in SAVR patients; this finding is especially important because stroke is one of the complications most concerning to physicians. Major stroke rates in patients who received the CoreValve System were 3.9 percent at 30 days and 5.8 percent at one year, while those same rates for patients with surgery were 3.1 percent (30 days) and 7.0 percent (one year). Patients also saw significant improvements in their quality of life (QoL). QoL scores improved 19.0 points for CoreValve patients and 3.7 points for surgical patients at 30 days.

The data were presented at a late-breaking clinical trial session at the 63rd Annual Scientific Session of the American College of Cardiology and simultaneously published in The New England Journal of Medicine. The CoreValve System was approved by the FDA in January 2014. See: "Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis" David H. Adams et al. New England Journal of Medicine March 29, 2014 DOI: 10.1056/NEJMoa1400590