A Medical Device Daily Staff Report

In patients with diabetes, the Cypher sirolimus-eluting coronary stent, produced by Cordis (Warren, New Jersey), outperformed the Taxus stent from Boston Scientific (Natick, Massachusetts), with significantly lower rates of in-segment restenosis, target lesion revascularization (TLR) and major adverse events at nine months, according to clinical data appearing recently in the Journal of the American College of Cardiology.

In this multi-center randomized clinical trial, the six-month rate of in-segment restenosis was more than five times lower for the Cypher stent compared to the Taxus (4.0% vs. 20.8%, respectively).

Most important for patients and physicians, key clinical outcomes measures were about four times lower for the Cypher — at nine-months, clinically driven TLR for the Cypher was 1.5% compared to 6% for the Taxus stent, while the composite clinical endpoint of MACE was 2% for the Cypher compared to 8% for the Taxus.

"These data provide interventional cardiologists with valuable new information about the use of drug-eluting stents in patients with diabetes, whose coronary artery disease presents such therapeutic challenges," said Seong-Wook Park, MD, PhD, principal investigator of this trial. Park is from the Asan Medical Center of the University of Ulsan College of Medicine (Seoul, South Korea).

"The significant reduction in restenosis associated with the Cypher stent, which translated to better outcomes for patients in terms of TLR and overall MACE, is impressive. It also is encouraging to note the data in this study on the safety of the Cypher stent in this difficult-to-treat patient population," Park added.

There was no difference between the two drug-eluting stents in the rates of death or myocardial infarction. The rate of death was 0% for the Cypher vs. 0.5% for the Taxus. The incidence of heart attack between the two groups was 0.5%.

The study included a total of 400 patients divided evenly between the Cypher and Taxus stent (200 each) from five academic medical centers in Korea between May 2005 and March 2006. All patients had clinically defined diabetes.

This study was supported by the Cardiovascular Research Foundation of South Korea and a grant from the Korean Ministry of Health and Welfare.

"This study adds to the growing body of clinical evidence about the Cypher sptent in diabetics with coronary artery disease," said Campbell Rogers, MD, chief technology officer at Cordis. "These data are consistent with other recently reported clinical trial data that clearly indicate that the Cypher stent performs differently than the Taxus stent in diabetics, which has been a topic of discussion and debate within the medical community for some time."

The Cypher stent does not have an approved indication for use in patients with diabetes in the U.S.