First Patient Enrolled in CYPRESS Dual Anti-Platelet Therapy Trial with CYPHER
September 1, 2009 – Cordis Corp. said 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 sirolimus-eluting coronary stent.
The procedure was performed by Patrick Flaherty, D.O., Arkansas Heart Hospital in Little Rock, Ark.
CYPRESS will also provide data to support the clinical evaluation of the company’s new NEVO sirolimus-eluting coronary stent in the NEVO III trial, a nonrandomized, single-arm trial evaluating the clinical outcomes of NEVO in about 1,200 patients in the United States and Canada. NEVO is the first DES utilizing RES TECHNOLOGY, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. Products using RES TECHNOLOGY are under development and are not approved or available for sale in any market.
“While the original clinical trials of the CYPHER 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. “CYPRESS will be used to support our premarket approval application in the U.S. for NEVO, 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 multivessel disease.
In addition, clinical data from CYPRESS (CYPherR for Evaluating Sustained Safety) will contribute to the approximately 20,000-patient independent Dual Anti-platelet 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 anti-platelet 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 stent and receive 12-months of dual anti-platelet 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 anti-platelet 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 anti-platelet 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 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. Coprincipal Investigator of both trials is David Kandzari, M.D., Scripps Clinic, San Diego, Calif. 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 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.
For more information: www.cypherstent.com, www.res-technology.com