PARTNER Analysis Supports Edwards Sapien TAVR Device in Diabetic Patients at High Risk for Surgery

September 3, 2013—Edwards Lifesciences (Irvine, CA) announced findings from a new post hoc data analysis of the PARTNER trial. This analysis showed that diabetic patients with aortic stenosis in need of heart valve replacement, but who were considered high surgical risk, experienced a 35% lower relative all-cause mortality rate 1 year after transcatheter aortic valve replacement (TAVR) compared to those treated with surgical aortic valve replacement (SAVR).

Brian Lindman, MD, presented the data analysis at the European Society of Cardiology's 2013 congress in Amsterdam. Dr. Lindman, who participated in the PARTNER trial as a clinical investigator, is also Assistant Professor of Medicine, Cardiovascular Division, at Washington University School of Medicine in St. Louis.

In the company's press release, Dr. Lindman commented, “While this was not a prespecified 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.”

As summarized by the company, in the analysis of diabetic patients in the as-treated high-risk cohort of the PARTNER trial, 1-year all-cause mortality was 18% in patients treated with the Edwards Sapien valve delivered via the femoral artery or a small incision between the ribs and 27.4% for patients treated with SAVR. Additionally, the analysis showed that diabetic patients treated with TAVR experienced quicker quality-of-life improvement and lower 1-year rates of renal failure than those treated with surgery. All percents are Kaplan-Meier estimates.

Edwards advised that the United States PARTNER trial is a randomized controlled trial of its transcatheter aortic valve. The trial's high-risk cohort (cohort A) included an as-treated population of 657 patients with severe, symptomatic aortic stenosis deemed high risk for traditional open heart surgery. Of those patients, 275 were diabetic and were treated with either TAVR (n = 145) or SAVR (n = 130). The post hoc analysis did not account for diabetic medications, severity/duration of diabetes, microvascular complications, or glucose control.

Dr. Lindman concluded that further studies are needed to understand how insulin treatment or the presence of metabolic syndrome may influence outcomes.

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