Edwards Lifesciences Announces Favorable Results in Sapien Valve Trial

September 24, 2013 – Edwards Lifesciences Corp. announced a new post-hoc data analysis from The PARTNER Trial demonstrated that diabetic patients with aortic stenosis in need of heart valve replacement, but at high surgical risk, experienced a 35 percent lower relative all-cause mortality one year after treatment with transcatheter aortic valve replacement (TAVR), as compared to those treated with surgical aortic valve replacement (AVR).

The data analysis was presented at the ESC Congress 2013 in Amsterdam by Brian Lindman, M.D., assistant professor of medicine, cardiovascular division, at Washington University School of Medicine in St. Louis.

"While this was not a pre-specified analysis of the trial and should be considered hypothesis generating, our study raises the possibility that TAVR may be the preferred approach for diabetic patients with severe symptomatic aortic stenosis who are at high surgical risk," said Lindman, who participated in The PARTNER Trial as a clinical investigator.

In the analysis of diabetic patients in the as-treated high-risk cohort of The PARTNER Trial, one-year all-cause mortality was 18 percent for patients treated with the Edwards Sapien valve delivered via the femoral artery or a small incision between the ribs, and 27.4 percent for patients treated with surgical aortic valve replacement. Additionally, the analysis showed that diabetic patients treated with TAVR experienced quicker quality of life improvement and lower one-year rates of renal failure than those treated with surgery.

The PARTNER Trial is the first randomized, controlled trial of a transcatheter aortic valve in the United States. The trial's high-risk cohort (Cohort A) included an as-treated population of 657 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery. Of those, 275 were diabetic and treated with either TAVR (n=145) or surgical AVR (n=130). The post-hoc analysis did not account for diabetic medications, severity/duration of diabetes, microvascular complications or glucose control. Lindman concluded that further studies are needed to understand how insulin treatment or the presence of metabolic syndrome may influence outcomes.

The Food and Drug Administration (FDA) approved the Sapien valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012.

For more information: www.edwards.com