MIAMI LAKES, Fla., Sept. 4 /PRNewswire/ -- In an extensive analysis of clinical trials known as a meta-analysis, the CYPHER(R) Sirolimus-eluting Coronary Stent was associated with significantly lower risks of blood clots and the need for reintervention compared to the Taxus Stent out to 30 months after an angioplasty procedure. This meta-analysis of 16 randomized clinical trials and 8,695 patients, the largest analysis of its kind to date, is now posted on the Journal of the American College of Cardiology website and is expected in print later in the year.
"Over the past year, concerns have been raised regarding the long-term safety of all drug-eluting stents," said Professor Albert Schomig, M.D., from Deutsches Herzzentrum, Technische Universitat in Munich, Germany, one of the authors of the study. "In this meta-analysis of randomized controlled trials, the CYPHER(R) Stent was associated with a significant reduction in the risks of stent thrombosis and reintervention compared to the Taxus Stent. This reinforces the notion that there are marked differences between the CYPHER(R) Stent and the Taxus Stent and that the safety of these drug-eluting stents must be assessed separately."
Professor Schomig added, "We find these data compelling because they are consistent with other documented meta-analyses and reflect data from all of the randomized clinical trials directly comparing these drug-eluting stents. Meta-analyses like this are an important and well-accepted statistical method among clinicians worldwide for documenting similarities and differences between two treatment modalities. We understand and appreciate that such studies are open to various interpretations by researchers and clinicians."
The primary safety endpoint of the meta-analysis was protocol-defined stent thrombosis while the secondary safety endpoints were death and heart attack (myocardial infarction or MI). The primary efficacy endpoint was the need for reintervention (target lesion revacularization or TLR).
According to this comprehensive analysis of all head-to-head clinical studies between the CYPHER(R) Stent and the Taxus Stent, a blood clot (stent thrombosis) is 34 percent less likely to form in patients implanted with the CYPHER(R) Stent than in patients who receive the Taxus Stent -- a statistically significant difference [hazard ratio (HR) 0.66, 95 percent confidence interval (CI) 0.46 to 0.94, p=0.02]. In addition, the CYPHER(R) Stent significantly lowered the risk of reintervention by 26 percent versus the Taxus Stent (HR 0.74, CI 0.63 to 0.87, p<0.001).
While the overall risk of death was not significantly different between the two drug-eluting stents (HR 0.92, CI 0.74 to 1.13, p=0.43), the authors of the meta-analysis identified a trend toward a lower risk of heart attack with the CYPHER(R) Stent versus the Taxus Stent (HR 0.84, CI 0.69 to 1.03, p=0.10), especially after the first year of follow-up.
Events occurring after the first year of stent placement have fueled the discussion surrounding the safety of drug-eluting stents. When only patient- level data were used, the authors were able to assess the occurrence of events after the first year of follow-up. In this analysis, there was a significant 70 percent reduction in blood clots (p=0.004) and a 55 percent reduction in repeat heart attacks (p=0.006) in patients who received the CYPHER(R) Stent compared to patients implanted with a Taxus Stent.
"This meta-analysis substantially enriches the large body of evidence that interventional cardiologists have at their disposal to make the right choice for their patients," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I, Chief Medical Officer, Cordis Corporation. "Drug-eluting stents, like the CYPHER(R) Stent, continue to provide significant benefits for patients with coronary artery disease."
For this analysis of randomized controlled trials, the gold standard of clinical evidence in medicine, individual patient data were obtained from 11 of the 16 included studies or 5,562 patients. The authors noted in the manuscript that the overall treatment effects were similar regardless of how the data were analyzed (total patient population or analysis of individual patient data).
The meta-analysis comprised studies of simple cases, studies that included all types of patients and studies that focused on specific and complex patient populations, such as patients with diabetes, patients treated for disease in long lesions or small vessels, patients presenting with a heart attack and patients being treated for repeat disease in a previously placed bare-metal stent, some of which are not within the approved labeling for the products.
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 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 SELECT(TM) Sirolimus- eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER SELECT(TM) 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 http://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. More information about Cordis Corporation can be found at http://www.cordis.com.
*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.
|SOURCE Cordis Corporation|
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