Medtronic announced the final follow-up results from the CoreValve CE pivotal study, which demonstrated excellent long-term durability at four years in patients with severe aortic stenosis who were treated with the self-expanding CoreValve system. The results were presented for the first time at the 63rd Annual Scientific Session of the American College of Cardiology.
According to Medtronic, the study results showed the long-term durability and excellent clinical performance of the CoreValve system with no incidences of structural valve dysfunction at four years. The study also showed significant improvements in quality of life at one year which were sustained through four years, with 74% of patients improving at least one New York Heart Association (NYHA) functional class from baseline to four years. Additionally, the rates of regurgitation and stroke remained low, with 83% of patients free from stroke at four-year follow-up.
Representing the first rigorous prospective evaluation of the CoreValve system and one of the first studies to report independent echocardiographic core laboratory-validated, long-term data for transcatheter valve durability, the CoreValve CE pivotal study enrolled 126 patients at nine centres throughout Europe and Canada. The study was designed to achieve CE mark for the CoreValve system to treat patients who were considered too ill or frail to have their aortic valves replaced through traditional open-heart surgery.
“We are very encouraged by these long-term durability results for the CoreValve system, which supplement the exceptional clinical outcomes demonstrated through the US pivotal trial,” says Rhonda Robb, vice president and general manager of Catheter Based Therapies at Medtronic. “For patients needing a less invasive approach for aortic valve replacement, this therapy is showing great promise with high survival rates, low stroke rates and now reliable durability out to four years.”
Presented earlier at ACC 2014, 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% in patients receiving the CoreValve system, compared to 19.1% in patients receiving SAVR at one year (non-inferiority p-value<0.001; superiority p-value=0.04). The CoreValve High Risk study is the first prospective, randomised study to show any transcatheter aortic valve to be superior to surgery.
The CoreValve system was approved by the US Food and Drug Administration (FDA) in January 2014 for patients considered extreme risk for surgery; the device is not currently approved in the US for use with patients at high risk. Since receiving CE mark approval in 2007, the CoreValve system has been implanted in more than 50,000 patients in more than 60 countries.