Edwards' 2-Year PARTNER Outcomes for High-Risk TAVR Patients Presented at ACC

March 26, 2012—Edwards Lifesciences (Irvine, CA) reported that longer-term results (≥ 2 years) from the high-risk Cohort A of the PARTNER trial were presented at the American College of Cardiology's (ACC) 61st Annual Scientific Session in Chicago and concurrently published online in The New England Journal of Medicine. 

PARTNER is a randomized, controlled trial comparing patients treated with surgical aortic valve replacement and patients treated with the Edwards Sapien transcatheter heart valve.



According to the company, all-cause mortality rate at 2 years for patients treated with Edwards Sapien transcatheter aortic valve replacement (TAVR) was 33.9%, which is statistically equivalent to open-heart surgical aortic valve replacement (AVR) at 35%. The investigators concluded, “This 2-year follow-up of patients in the PARTNER trial supports the use of TAVR as an alternative to surgery in selected high-risk patients with aortic stenosis. The two treatments were similar with respect to mortality, reduction in cardiac symptoms, and improved valve hemodynamics.” The presentation also included available data out to 36 months, which trended similarly. 


The investigators noted that earlier results raised concerns that TAVR was responsible for increased early and, possibly, late strokes. However, over the reported follow-up period from the PARTNER trial, the available data just presented and published showed no significant difference in the risk of stroke between TAVR and surgery patients.

The PARTNER investigators also analyzed predictors of mortality for the overall trial cohort and for each of the randomized groups. They reported an association of paravalvular regurgitation after TAVR with late mortality, possibly related to factors including the ratio of the transcatheter-valve size to the patient's native valve size. The investigators stated, “Recently, the routine use of three-dimensional imaging techniques has improved annulus sizing, resulting in better selection of properly sized valves.”


Edwards stated that Cohort A of the trial enrolled between May 2007 and September 2009 and studied 699 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery. Patients were evaluated by a multidisciplinary heart team and were evenly randomized to receive either traditional open-heart surgery or the Edwards Sapien valve with transfemoral or transapical delivery. The study represented the initial experience with TAVR at most sites, and the use of first-generation delivery systems. The PARTNER trial achieved its primary endpoint, concluding that survival of patients treated with the Edwards Sapien valve at 1 year was equivalent to those treated with surgery.

The 2-year data from the inoperable Cohort B of the PARTNER trial were also published by Raj Makkar, MD, et al online in The New England Journal of Medicine. The data were first presented by Dr. Makkar in November 2011 at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, as reported in Cardiac Interventions Today. 

The Edwards Sapien transcatheter heart valve received US Food and Drug Administration (FDA) approval for the treatment of certain inoperable patients in November 2011, as reported in Cardiac Interventions Today. The device is currently under investigation for the treatment of high-risk patients in the United States and is awaiting approval for this population. After the primary endpoint analysis, Edwards submitted 1-year data from Cohort A of the PARTNER trial to the FDA in April 2011, the company advised.