November 5, 2012 — Edwards Lifesciences Corporation announced three-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards Sapien transcatheter heart valve. The data from The PARTNER Trial (Cohort B) demonstrated a sustained and increasing survival benefit for Sapien valve patients at three years, as well as significantly less time spent in the hospital. The new results were presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
The three-year all-cause mortality rate for transcatheter aortic valve replacement (TAVR) patients was 54.1 percent, as compared to 80.9 percent for those patients receiving standard therapy. Despite the advanced age and comorbidities of this inoperable patient population, the mortality rates in the third year of follow-up were 19.3 percent for TAVR patients and 40.3 percent for control. Also of note, TAVR patients experienced a median period of time out of the hospital that was more than two-and-a-half times longer than that of standard therapy patients.
There was a higher stroke rate in the transcatheter group as compared to standard therapy, although the two additional events between the second and third years of follow-up were adjudicated to not be related to the procedure or the device.
"We are very pleased that the inoperable patients in The PARTNER Trial continued to experience benefits in all the key measures of clinical outcomes. The performance and durability of the Edwards Sapien valve also remained excellent," said Michael A. Mussallem, Edwards' chairman and CEO. "The three-year data further highlight the devastating effects of symptomatic severe aortic stenosis in patients receiving only standard therapy — reinforcing the important role that transcatheter valve replacement plays in the treatment of these patients."
This trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for traditional open-heart surgery. Patients were evenly randomized to receive either the Sapien valve or standard therapy. The U.S Food and Drug Administration (FDA) approved the Sapien valve in November 2011 for the treatment of inoperable patients, and also approved Sapien for high-risk surgical patients.
For more information: www.edwards.com