Healthcare Industry News: drug-eluting stent
News Release - October 22, 2007
New Long-Term Data Suggest Clinical Differences in Safety and Efficacy between CYPHER(R) Sirolimus-Eluting Coronary Stent and Taxus StentComparison Using 15-month Western Denmark Heart Registry Results Presented at TCT 2007
WASHINGTON--(HSMN NewsFeed)--An analysis of fifteen-month data from the Western Denmark Heart Registry found that patients who received the CYPHER® Sirolimus-eluting Coronary Stent had a lower risk of blood clots (stent thrombosis) and were less likely to need another procedure at the same lesion site (target lesion revascularization) than patients who received a Taxus Stent. The study is being shown at the Transcatheter Cardiovascular Therapeutics 2007 meeting (TCT 2007).
The differences between the CYPHER® Stent and the Taxus Stent in terms of definite stent thrombosis, definite/probable/possible stent thrombosis and target lesion revascularization were statistically significant and favorable for the CYPHER® Stent. Patients who received the Taxus Stent were 55 percent more likely to develop definite stent thrombosis than patients who received the CYPHER® Stent (confidence interval (CI) 0.21-0.94). Taxus Stent patients were also 49 percent more likely to develop definite/probable/possible stent thrombosis than patients who received a CYPHER® Stent (CI 0.30-0.87). In addition, the CYPHER® Stent performed considerably better than the Taxus Stent in terms of target lesion revascularization, as Taxus Stent patients were 32 percent more likely to need a repeat procedure compared with patients who received the CYPHER® Stent (CI 0.52-0.90).
“The study data show that the clinical outcomes following drug-eluting stent implantation may depend on the type of stent used to treat a patient with coronary artery disease,” said Professor Leif Thuesen, MD, DMSci, from Aarhus University Hospital in Denmark.
“The CYPHER® Stent continues to demonstrate excellent outcomes in clinical trials and in real-world settings,” said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. “These findings are consistent with the results of other studies recently published in peer-reviewed medical journals (i.e. Stettler et al. Lancet 2007;370:937-48, Schömig et al. J Am Coll Cardiol 2007;50:1373-80, and Daemen et al. Lancet 2007;369:667-78) and build on the growing body of evidence indicating that the CYPHER® Stent and the Taxus Stent should be evaluated separately.”
The Western Denmark Heart Registry is a multi-center, prospective, observational registry of all patients in western Denmark who receive coronary angiograms or coronary interventions, including percutaneous interventions and bypass surgery. This analysis evaluated patients from the registry who received a drug-eluting stent— either the CYPHER® Stent or Taxus Stent—from January 2002 through June 2005. Patients who received a combination of drug-eluting and bare metal stents (BMS) were excluded. All patients were followed for 15 months.
The primary endpoints of the study were stent thrombosis, myocardial infarction and death. No significant differences were found in the clinical outcomes of myocardial infarction or death.
Stent thrombosis was defined according to the Academic Research Consortium (ARC) definitions for thrombosis: definite, which required confirmation of a clot by angiogram at follow-up; probable, which included a heart attack in the treated vessel in patients who did not have an angiographic confirmation of a thrombosis; and possible, which included sudden unexplained death.
About the CYPHER® Stent
The CYPHER® Stent is the most studied drug-eluting stent in history and has been chosen by cardiologists worldwide to treat more than 3 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 that examine the performance of the CYPHER® Stent in a broad range of patients.
The CYPHER® 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 a sirolimus-eluting stent, the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER SELECT™ Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About Cordis Corporation
Cordis, 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.
(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Cordis’ expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Cordis does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
*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®. Rapamune is a trademark of Wyeth Pharmaceuticals.
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