The long-term safety of the CYPHER(R) Sirolimus-eluting Coronary Stent, specifically in terms of death, myocardial infarction (heart attacks) and stent thrombosis (also known as blood clots), is comparable to that of bare metal stents when used according to product labeling, according to a variety of studies appearing today in the New England Journal of Medicine (NEJM).
These studies also confirm the long- term efficacy of the CYPHER(R) Stent in substantially reducing the need for another interventional procedure (revascularization) compared to bare metal stents.
“We are extremely pleased that long-term data from multiple on-label randomized, controlled clinical studies comparing the CYPHER(R) Stent with bare metal stents are now published in a peer reviewed journal,” said David Kandzari, M.D., F.A.C.C., F.S.C.A.I, Chief Medical Officer, Cordis Cardiology division of Cordis Corporation. “These studies reaffirm the long-term safety and efficacy of this important treatment option for coronary artery disease. This should give more confidence to interventional cardiologists and their patients.”
Clinical data covered by NEJM were presented previously at the U.S. Food and Drug Administration advisory panel hearing in December 2006 on the safety of drug-eluting stents.
Dr. Kandzari noted that the current CYPHER(R) Stent database, which includes more than 45,000 patients, represents the broadest clinical data set of any drug-eluting stent and that studies evaluating the CYPHER(R) Stent in higher risk patients not currently within the approval labeling, including those with diabetes and lesion subgroups, will continue to be a focus of ongoing clinical research at Cordis.
“We are committed to continuously building on the growing body of clinical knowledge about the CYPHER(R) Stent and its use in a variety of patients and lesion types so interventional cardiologists and their patients can discuss all treatment options for coronary artery disease,” said Dr. Kandzari. “The goal of our clinical research program is to examine early and late efficacy and safety outcomes, including the safety and efficacy of anti-platelet therapy and its relationship to stent thrombosis. Through ongoing randomized controlled clinical trials we can understand better the safety and efficacy of the CYPHER(R) Stent when used in complex patients not originally included in early clinical trials, which is often referred to as ‘off-label’ use.”
Cordis conducts both randomized clinical trials as well as ‘real world’ registries to continuously gather data about the use of the CYPHER(R) Stent. “While data from registries, like that from Sweden in this edition of the Journal, are helpful in providing insights into off-label use, they are not definitive and need to be confirmed with randomized, controlled clinical trials, which are the highest level of clinical evidence in medicine,” Dr. Kandzari said.