Multiple Articles in the New England Journal of Medicine Confirm On-Label, Long-Term Safety and Efficacy of the Cypher Sirolimus-Eluting Coronary Stent Compared to Bare Metal Stents
MIAMI LAKES, Fla., February 12, 2007 /PRNewswire/ -- 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.
Pooled Analysis of 14 Randomized Clinical Trials
NEJM includes a report of a pooled analysis of patient-level data out to five years from 14 randomized controlled trials comparing the CYPHER(R) Stent to bare metal stents in more than 4,900 patients. This is the most comprehensive study conducted to date; it provides the most in depth information about the safety and efficacy of the product.
It encompasses randomized controlled studies of on-label use, as well as dedicated studies of broader patient populations not within the approved labeling. Currently, off-label use would include those with diabetes, in- stent restenosis, chronic total occlusions, acute myocardial infarction and unselected patient populations.
In this meta-analysis, there was no significant difference in the overall risk of stent thrombosis between the CYPHER(R) Stent and bare metal stents over four years (p=0.16) although there was an increase in risk of stent thrombosis with the CYPHER(R) Stent after one year. However, if patients who had intervening repeat revascularizations are included in the analysis, as they are when applying definitions of stent thrombosis developed by the Academic Research Consortium, there were eight late thromboses in patients treated with the CYPHER(R) Stent and six in those treated with bare metal stents.
In addition, the overall risk of death and the combined risk of death and myocardial infarction (heart attack) were not significantly different between the two treatment arms (p=0.76) in the meta analysis. Of note, there was also a significant reduction in the combined risk of death, myocardial infarction or reintervention with the CYPHER(R) Stent compared to bare metal stents (p<0.001).
People with Diabetes Treated with the CYPHER(R) Stent
People with diabetes are known to be at increased risk of coronary complications. However, in this pooled analysis, the use of the CYPHER(R) Stent in patients with diabetes was not associated with a higher risk of death or the combined endpoint of death or myocardial infarction. Data from earlier clinical trials and registries of the safety and efficacy of drug-eluting stents in patients with diabetes were inconsistent. The use of the CYPHER(R) Stent and other drug-eluting stents in patients with diabetes is not presently within approved labeling for these devices.
Dr. Kandzari noted that the total body of clinical evidence, particularly with randomized clinical trials, does not suggest there is an excess mortality with the CYPHER(R) Stent in either the total population or in patients with diabetes.
"We share the concern of physicians and patients about the risk of late stent thrombosis and are expanding our long-term clinical trials (SIRIUS, e- SIRIUS and c-SIRIUS) out to eight years to continue gathering clinical information," said Dr. Kandzari. "We know late stent thrombosis may be related to various factors including the discontinuation of dual anti-platelet therapy. While the medical community endeavors to better understand the optimal length of therapy for anti-platelet therapy, we support guidelines recently announced by key medical and patient societies, namely the American Heart Association, the of Cardiology and the Society for Interventions and Angiography, that recommend up to 12 months of anti-platelet therapy for patients who can tolerate it."
About the CYPHER(R) Stent
The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies, including a number of independent clinical trials, that examine the performance of the CYPHER(R) Stent in a broad range of patients.
Developed and manufactured by Cordis Corporation, the CYPHER(R) Stent is currently available in more than 80 countries and has the broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of sirolimus-eluting stent, the CYPHER(R) SELECT(TM) Sirolimus- eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. CYPHER(R) SELECT(TM) Plus, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the U.S.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease.
* Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune(R). Rapamune is a trademark of Wyeth Pharmaceuticals.
Posted: February 2007