August 28, 2008 – In patients with diabetes, the CYPHER Sirolimus-eluting coronary stent outperformed the Taxus stent with significantly lower rates of in-segment restenosis, target lesion revascularization 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 stent (4 percent vs. 20.8 percent respectively). Most important for patients and physicians, key clinical outcomes measures were about four times lower for the CYPHER stent at nine-months, clinically driven TLR for the CYPHER stent was 1.5 percent compared to 6 percent for the Taxus stent, while the composite clinical endpoint of MACE was 2 percent for the CYPHER stent compared to 8 percent 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, M.D., Ph.D., FACC, and principal investigator of this trial. Dr. Park is from the Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Cordis has no financial relationship with Dr. Park.
“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,” Dr. Park continued.
There was no difference between the two drug-eluting stents in the rates of death or myocardial infarction (heart attack). The rate of death was 0 percent for the CYPHER vs. 0.5 percent for the Taxus. The incidence of heart attack between the two groups was 0.5 percent.
The study included 400 patients divided evenly between the CYPHER Stent and the 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 (Korea) and a grant from the Korean Ministry of Health and Welfare.
The CYPHER Stent does not have an approved indication for use in patients with diabetes in the U.S.
For more information: www.cypherstent.com, www.cordis.com, www.acc.org