Healthcare Industry News: drug-eluting stent
News Release - October 4, 2006
Data Suggest Different Outcomes Between The CYPHER(R) Sirolimus-Eluting Coronary Stent and the Taxus Stent In 'Real World' Settings and Small VesselsStudies and accompanying editorial in the Journal of the American College of Cardiology further highlight differences between drug-eluting stents
MIAMI, Oct. 4 (HSMN NewsFeed) -- The CYPHER® Stent outperformed the Taxus Stent in small coronary vessels and every-day medical practice in two studies published in this week's edition of the Journal of the American College of Cardiology. The results of one of the studies were reviewed in an accompanying editorial.
A large German study involving more than 2,000 patients from Deutsches Herzzentrum and First Medizinische Klinik rechts der Isar followed for 9 months found the CYPHER® Stent to be significantly more effective at preventing repeat procedures (target lesion revascularization or TLR) in small coronary vessels measuring less than 2.41 mm in diameter. More specifically, the CYPHER® Stent had a TLR rate of 8.6 percent in such vessels, while the TLR rate of the Taxus Stent in the same type of vessels was 16.4 percent. The difference was statistically significant (p=0.002).
Small coronary vessels have been associated with an increased risk of re-blockage (restenosis) after stent implantation, which requires another procedure to re-open the vessel. In this study, patients treated with the CYPHER® Stent had a lower risk of needing repeat procedures.
"The sheer size of the trial and high angiographic follow-up rates provide compelling evidence" supporting the use of the CYPHER® Stent in small vessels, wrote Bradley H. Strauss, M.D., PhD, FACC, from the University of Toronto, Canada, in the accompanying editorial.
The second study analyzed the 1-year clinical results of the large multi-center REAL Registry (REgistro regionale AngiopLastiche dell'Emilia- Romagna) in Italy and concluded that the CYPHER® Stent significantly reduced the incidence of major adverse cardiac events or MACE, mainly by decreasing the need for repeat procedures (target vessel revascularization or TVR) compared to the Taxus Stent. In this 1,676 patient analysis, the rates of MACE, defined to include all death, heart attack (myocardial infarction) and TVR, were 9.2 percent for the CYPHER® Stent and 14.1 percent for the Taxus Stent (p=0.007). In addition, the TVR rate of the Taxus Stent (10.0 percent) was twice as much as the TVR rate of the CYPHER® Stent (5.0 percent), a difference that was also statistically significant (p=0.0008).
According to the authors, "The major finding of this study is that in a real-world complex population, [the CYPHER® Stent] is associated with a lower risk of reinterventions compared to the [Taxus Stent]. This result deserves some attention, because a very intense debate is ongoing about the relative performance of these 2 drug-eluting stents in clinical practice."
"The 'real-world' and clinical-trial evidence supporting the use of the CYPHER® Stent over the Taxus Stent continues to grow," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "With these two studies, interventional cardiologists have more reasons to consider the CYPHER® Stent to treat patients who present challenging cases of coronary artery disease."
While the CYPHER® Stent came out on top in both studies, the German study did not find significant differences between the TLR rates of the CYPHER® Stent and the Taxus Stent in large vessels. In addition, no statistical differences were found between the death and myocardial infarction rates of the two stents in the Italian registry.
Both studies were conducted independently.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat more than 2 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 60 studies, inclusive of independent clinical trials, that examine the performance of the CYPHER® Stent in a broad range of patients.
Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in more than 80 countries and has the longest-term clinical follow-up of any drug-eluting stent. The first next-generation drug-eluting stent, the CYPHER SELECT(TM) Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER SELECT(TM) Plus Stent, the first third-generation drug-eluting stent, received the CE mark in June 2006 and is now available in many markets outside the United States.
The CYPHER® Stent is indicated in the United States for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length less than or equal to 30 mm in native coronary arteries with a reference vessel diameter of less than or equal to 2.5 mm to less than or equal to 3.5 mm.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the 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®. Rapamune is a trademark of Wyeth Pharmaceuticals.
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