Healthcare Industry News: stent thrombosis
News Release - August 31, 2009
First Patient Enrolled in CYPRESS, a Dual Antiplatelet Therapy Trial with the CYPHER(R) Sirolimus-Eluting Coronary StentTrial Also Marks Important Step Forward in Clinical Development of the NEVO(TM) Sirolimus-eluting Coronary Stent
BRIDGEWATER, N.J.--(HSMN NewsFeed)--Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced today that the first patient has been enrolled in the CYPRESS study, which will assess clinical outcomes in a broad range of patients with coronary artery disease who take dual anti-platelet therapy after receiving a CYPHER(R) Sirolimus-eluting Coronary Stent. The procedure was performed by Patrick Flaherty, D.O., Arkansas Heart Hospital in Little Rock, AK.
CYPRESS will provide data to support the clinical evaluation of the company’s new NEVO(TM) Sirolimus-eluting Coronary Stent in the NEVO III trial, a non-randomized, single-arm trial evaluating the clinical outcomes of NEVO(TM) in approximately 1,200 patients in the United States and Canada. NEVO(TM) is the first drug-eluting stent utilizing RES TECHNOLOGY(TM), which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. Products using RES TECHNOLOGY(TM) are under development and are not approved or available for sale in any market.
“While the original clinical trials of the CYPHER(R) Stent have demonstrated sustained efficacy and similar safety to bare-metal stents through five years of follow-up, many technical improvements in percutaneous coronary interventions and concomitant therapy may lead to even better outcomes with the world’s most studied drug-eluting stent,” said Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation.
Dr. Rogers continued, “CYPRESS will be used to support our pre-market approval application in the U.S. for NEVO(TM), which we believe has the potential to return Cordis to global leadership in the drug-eluting stent market.”
CYPRESS will enroll an estimated 2,000 patients at approximately 200 centers throughout the U.S. The patients in this study will represent a variety of coronary artery disease cases including those considered ‘complex’ due to multi-vessel disease.
In addition, clinical data from CYPRESS (CYPherR for Evaluating Sustained Safety) will contribute to the approximately 20,000-patient independent Dual Antiplatelet Therapy (DAPT) Study, a unique collaboration amongst the U.S. Food and Drug Administration, drug and device manufacturers and Harvard Clinical Research Institute. The DAPT Study concept was developed by a group of stent manufacturers and manufacturers of antiplatelet medications who came together to address a FDA request for this post-market study. The Harvard Clinical Research Institute is responsible for the scientific conduct and independent analysis of the overall study.
The CYPRESS trial is divided into two phases. In Phase I, patients will receive the CYPHER(R) Stent and receive 12-months of dual antiplatelet therapy with a thienopyridine - clopidogrel or prasugrel - and aspirin. The primary endpoint of this portion of the trial is target lesion failure at 12-months.
In Phase II, patients treated with 12-months of dual antiplatelet therapy from Phase I, who remain free from death, heart attack, stroke, the need for another procedure (revascularization), stent thrombosis and major bleeding are then eligible for randomization to either placebo or an additional 18-months of thienopyridine therapy. All patients in Phase II will continue aspirin therapy. The primary endpoints of Phase II are rates of Major Adverse Coronary and Cerebrovascular Events, also known as MACCE, stent thrombosis and bleeding.
“There continues to be debate among clinicians as to the optimal duration of dual antiplatelet therapy and the results from CYPRESS will add important information to our understanding of the role of dual antiplatelet therapy in patients who receive a CYPHER(R) Stent,” said Daniel I. Simon, M.D., Principal Investigator of both CYPRESS and NEVO III. Dr. Simon is Director, Harrington-McLaughlin Heart & Vascular Institute at University Hospitals Case Medical Center in Cleveland, Ohio. Co-Principal Investigator of both trials is David Kandzari, M.D., Scripps Clinic, San Diego, CA. Drs. Simon and Kandzari are compensated for their time as Principal Investigators.
The DAPT Study is an independent, large-scale study in size and scope intended to compare two durations (12 months and 30 months) of dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication to reduce the risk of blood clots) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of coronary stents.
The course of anti-platelet therapy for the CYPHER(R) Stent used in the pivotal clinical study supporting its approval was three months. In late 2006, however, the company announced its support of the recommendations of the percutaneous coronary revascularization guidelines from the American Heart Association, the American College of Cardiology and The Society for Cardiovascular Angiography and Interventions which recommend up to 12 months of aspirin and clopidogrel for patients who are considered to be at low risk for bleeding complications.
About the CYPHER(R) Stent
The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat more than 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 200 randomized and nonrandomized studies that examine the performance of the CYPHER(R) Stent in a broad range of patients. A number of these studies have data now out to seven years.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About RES TECHNOLOGY(TM)
RES TECHNOLOGY(TM) is a stent design that incorporates in the stent struts hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75 percent bare metal upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo data. By contrast, currently marketed drug-eluting stents have 100 percent of their surfaces coated with drug and polymer and the polymer is never fully bioabsorbed.
Products using RES TECHNOLOGY(TM) are under development and are not approved or available for sale in any market.
More information about RES TECHNOLOGY(TM) can be found at www.res-technology.com.
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson & Johnson company, has been 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 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.
**The third party trademarks used herein are trademarks of their respective owners.
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