PARTNER's 2-Year Inoperable Cohort Data Support Edwards Sapien Valve

November 10, 2011—Edwards Lifesciences Corporation (Irvine, CA) announced 2-year results from the PARTNER trial's cohort B, which was composed of 358 inoperable patients with severe aortic stenosis who were evenly randomized to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Sapien transcatheter heart valve or standard therapy. PARTNER is the pivotal clinical study of the Edwards Sapien valve, which received US Food and Drug Administration approval on November 2, 2011. Raj Makkar, MD, presented the data the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.

According to the company, the data demonstrated a widening survival benefit, including significantly less time spent in the hospital, at 2 years for Sapien valve patients. At 1 year, all-cause mortality was 30.7% for TAVR and 50.7% for standard therapy. The 1-year cohort B data were published in September 2010 in The New England Journal of Medicine (2010;363:1597–1607). At 2 years, mortality for patients treated with TAVR remained superior to standard therapy, with the mortality curves diverging further to demonstrate rates of 43.3% versus 67.6%, respectively. In addition to the clinical advantages, the new data demonstrated that the improvement in hemodynamic performance was sustained at 2 years. However, there was a higher neurologic event rate in the transcatheter group as compared to standard therapy.

"The mortality advantage grew significantly at 2 years,” commented Dr. Makkar. “Remarkably, the median days alive outside of the hospital was 699 days in TAVR patients and 355 days for standard therapy patients—a difference of nearly 1 year. This demonstrates that without the Sapien valve, patients that survived spent significantly more time in the hospital."