Cordis Corporation (Cordis), has enrolled the first patient in CYPRESS trial. The trial will assess clinical outcomes in a wide range of patients with coronary artery disease who take dual anti-platelet therapy after receiving a CYPHER Sirolimus-eluting Coronary Stent. Patrick Flaherty, D.O., Arkansas Heart Hospital in Little Rock, Arkansas has performed the procedure.
CYPRESS will provide data to support the clinical evaluation of the company’s new NEVO Sirolimus-eluting Coronary Stent in the NEVO III trial, a non-randomized, single-arm trial evaluating the clinical outcomes of NEVO in approximately 1,200 patients in the United States and Canada. NEVO is the first drug-eluting stent utilizing RES TECHNOLOGY, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded.
“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 Corporation.
Dr. Rogers continued: “CYPRESS will be used to support our pre-market approval application in the US for NEVO.”
CYPRESS will enroll an estimated 2,000 patients at approximately 200 centers throughout the US. 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 US Food and Drug Administration, drug and device manufacturers and Harvard Clinical Research Institute.
The CYPRESS trial is divided into two phases. In Phase I, patients will receive the CYPHER 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 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 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.