Data From PARTNER Trial to be Presented at ACC 2011
March 29, 2011 – One-year outcomes from Cohort A of the PARTNER trial will be presented April 3 at the American College of Cardiology’s (ACC) 60th Annual Scientific Session and Expo in New Orleans. Additionally, economic data from Cohort B will be featured in a session immediately after.
The PARTNER Trial is the world's first randomized clinical trial of a transcatheter aortic heart valve and is studying the Edwards Sapien valve in both operable (Cohort A) and inoperable (Cohort B) patients with severe aortic stenosis. Cohort A compares outcomes after treatment with either the Sapien valve or traditional open-heart surgery in 699 high-risk, operable patients. The study is a "non-inferiority" trial designed to evaluate whether patient outcomes after transcatheter aortic valve replacement with the device are comparable to surgical outcomes in these patients.
Cohort B compared outcomes after treatment with either medical management or the valve in 358 inoperable patients. In September 2010, The New England Journal of Medicine published data on Cohort B, showing it successfully met the primary endpoints of all-cause mortality and mortality plus repeat hospitalization.
The heart valve is an investigational device in the United States.
For more information: www.edwards.com