GAITHERSBURG, Md., Dec. 7 /PRNewswire/ -- Cordis Corporation stated to an advisory panel to the U.S. Food and Drug Administration (FDA) that analysis of its research on the CYPHER(R) Sirolimus-eluting Coronary Stent suggests a need for additional education on anti-platelet therapy regimens for bare-metal and drug-eluting stent patients and further research to understand safety factors. Further, Cordis committed to support efforts by the clinical community, medical societies and industry to achieve these goals. The company's conclusions are based on an independent analysis of long-term clinical data for the CYPHER(R) Stent that was presented today.
This independent analysis, conducted and presented by the Harvard Clinical Research Institute, confirmed that the safety and clinical benefits of the CYPHER(R) Stent extend out to four years. The data, based on four randomized controlled clinical trials, suggested that there was no significant difference in the incidence of thrombosis between the CYPHER(R) Stent and bare-metal stents.
"We are actively engaged in a global, multi-faceted approach that includes clinical evidence and education to serve patients and the doctors that treat them," said Campbell Rogers, M.D., Chief Technology Officer, Cordis Corporation. "Cordis will continue to work with the medical community to educate and inform physicians and patients about contributing factors to thrombosis with drug-eluting stents and methods to reduce this risk."
Since the initiation of the first pivotal clinical trial in support of product approval for the CYPHER(R) Stent, Cordis has included stent thrombosis as a clinical endpoint and continues this approach to further advance understanding of this clinical challenge. In October, the company announced a study of the multiple factors that may lead to the condition and potential benefits of medical regimens. A patient registry, currently underway in Europe and Asia/Pacific, will now extend to the U.S. and will include a prospective randomized subset of 15,000 patients. This expanded registry will evaluate a variety of safety and efficacy measures, including the need for repeat procedures (target lesion revascularization), major adverse cardiac events such as heart attack and death, in-stent blood clots (stent thrombosis), as well as detailed information about the use of dual anti-platelet therapy.
Additionally, the company announced at that time that it would extend follow up to eight years the SIRIUS, E-SIRIUS and C-SIRIUS clinical trials, which were each originally designed to end after five years. Together, the new registry and expanded clinical trials will provide ongoing information about the safety and efficacy of the CYPHER(R) Stent, especially in terms of stent thrombosis, a rare but serious clinical event.
The company also announced plans to create a global awareness campaign to educate physicians and patients about guidelines from leading patient and professional medical societies about anti-platelet therapy. These guidelines, which are endorsed by the American Heart Association (AHA), the American College of Cardiology (ACC) and the Society for Cardiology Angiography and Intervention (SCAI), suggest physicians consider a one-year duration of anti-platelet therapy in patients receiving drug-eluting stents.
"While we need to understand better the exact duration of anti-platelet therapy for patients who have received a drug-eluting stent, we believe it is prudent for physicians and patients to follow guidelines from the AHA, ACC and SCAI until we have more clinical evidence," said Dr. Rogers. "Our educational campaign will include disseminating broadly these guidelines to physicians, especially those most often faced with questions about the discontinuation of anti-platelet therapy, and creating a patient guide to understanding the guidelines."
Clinical Data Presented at the FDA Panel Meeting
The independent, intent-to-treat analysis presented by the Harvard Clinical Research Institute, which applied a new, broad consensus definitions developed by academic investigators, industry and regulators known as the Academic Research Consortium (ARC), demonstrated that the rate of any thrombosis from 0-4 years was 3.5 percent (29 patients from a pool of 832) for the CYPHER(R) Stent arm and 3.4 percent (28 patients from a pool of 825) for bare-metal stents. The analysis was performed on the complete four-year data of 1,748 patients, the longest of any drug-eluting stent, from the randomized clinical trials SIRIUS, E-SIRIUS, C-SIRIUS and RAVEL, all of which compared the CYPHER(R) Stent to bare-metal stents in the treatment of de novo coronary artery lesions. The data did demonstrate differences in the timing of the incidence of such events between bare-metal and drug-eluting stents. At no point throughout the four-year period were the differences significant. Analyses of sub-populations are ongoing.
The ARC definitions for thrombosis included 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 that could not be attributed to another cause, such as a car accident or cancer. These definitions were used to capture all possible adverse events that might be attributable to stent thrombosis and to thoroughly evaluate the long-term safety of potential treatments for coronary artery disease.
Thrombosis that was considered "definite or probable," a more specific assessment of the rates of thrombosis in the two treatment arms according to the ARC definitions, was 1.6 percent (13 out of 832 patients) in the CYPHER(R) Stent group and 1.7 percent (15 out of 870 patients) in the bare-stent arm from 0-4 years.
"Our analysis shows that the CYPHER(R) Stent is not associated with an increased overall risk of thrombosis, also known as blood clots, when compared to the same bare-metal stents out to four years," said Laura Mauri, M.D., M.Sc., Chief Scientific Officer, Harvard Clinical Research Institute (HCRI), Cambridge, Mass., and an interventional cardiology who presented the data during the FDA advisory panel.
The ARC group, led by Professor Patrick Serruys, M.D., The Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands and Dr. Cutlip, created the standardized definitions to facilitate uniform assessment of data for drug-eluting stents. The Consortium represented participants in the "Scientific Working Sessions on Study Endpoints in PCI Trials" earlier this year in Washington and Dublin, including HCRI, the Cardiovascular Research Foundation and Duke Clinical Research Institute from academia; the FDA, several academic medical centers and hospitals, and, from industry, Abbott Vascular, Boston Scientific, Cordis Corporation, Conor Medsystems and Medtronic.
Cordis has been a strong advocate of industry-wide independent adjudication of all clinical trial data using standardized definitions, believing that it is vital to an understanding of the safety of drug-eluting stents.
About the CYPHER(R) Stent
More than two million worldwide patients with coronary artery disease have been treated with the CYPHER(R) Stent. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies, inclusive 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 longest-term clinical follow-up of any drug-eluting stent. The first next-generation drug-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 Sirolimus-eluting Coronary 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.
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.
Cordis CorporationCONTACT: Christopher Allman of Cordis Cardiology, (O) +1-786-313-2303, (M)+1-305-586-6024, Callman1@crdus.jnj.com; Todd Ringler of Edelman, (O)+1-781-599-7542, (M) +1-617-872-1235, Todd.ringler@edelman.com, for CordisCorporation
Web site: http://www.cordis.com/
