From Cordis Corporation
Preliminary US study findings support excellent results with CYPHER Sirolimus-eluting Stent
Major reductions in angiographic in-stent restenosis and late lumen loss
PARIS (May 22, 2002) -- Clinical investigators today reported preliminary findings at The Paris Course on Revascularization (PCR) documenting the excellent results of the CYPHER™ Sirolimus-eluting Stent in the first 400 patients enrolled in the landmark SIRIUS study. SIRIUS is a large-scale, randomized, double-blind, controlled clinical trial involving 53 U.S. treatment centers and 1,101 patients. The study was sponsored by Cordis Corporation, a Johnson & Johnson company.
Co-Principal Investigators, Martin B. Leon, M.D., and Jeffrey W. Moses, M.D., Interventional Cardiology, Cardiovascular Research Foundation, Lenox Hill Hospital, New York, NY, presented 8-month angiographic and 9-month clinical data. Peter J. Fitzgerald, M.D., Ph.D., Associate Professor of Medicine and Director of the CV Core Analysis Laboratory, Stanford University Medical Center, Palo Alto, CA, presented 8-month intravenous ultrasound (IVUS) data on 96 patients.
The SIRIUS preliminary data are the most recent in a series of study findings evaluating the efficacy and safety of the CYPHER™ Sirolimus-eluting Stent in reducing reblockage of de novo coronary artery lesions.
"We are extremely impressed by the consistency in findings between the preliminary SIRIUS data and the results of the large-scale RAVEL* study in Europe and Latin America," said Dr. Leon.
Eight-month angiographic follow-up showed virtually no in-stent late lumen loss (0.14 mm) in patients treated with the CYPHER™ Stent, mirroring the 6-month findings of the RAVEL study and the 2-year findings of the First-in-Man study. The 2% rate of angiographic in-stent restenosis -- representing a 94% reduction versus the control arm (bare metal stent) -- supports the findings of earlier studies.
"The major reductions in angiographic in-stent restenosis and late lumen loss associated with the CYPHER™ Sirolimus-eluting Stent are proving to be remarkably similar from study to study," said Dr. Leon. "Sustained evidence of minimum in-stent late lumen loss is one of the most reliable indicators cardiologists have to gauge the long-term efficacy of interventional therapy."
"The angiographic findings are confirmed by the IVUS analysis which demonstrated the 94% reduction in neointimal volume (restenosis) compared with the control," said Dr. Fitzgerald. "Additionally, there were no differences in vessel integrity or degree of intimal hyperplasia (cell formation) at the stent margins between the two groups. Further, there were no events of malapposition (vessel wall pulling away from the stent) with the CYPHER™ Stent in this subset of patients. The incidence of incomplete stent apposition was comparable between the two groups."
SIRIUS Co-Principal Investigator Dr. Moses explained one of the major objectives of the SIRIUS study is to evaluate the performance of the CYPHER™ Sirolimus-eluting Stent across a broad spectrum of patient profiles, including seriously ill patients.
"The SIRIUS trial is putting the CYPHER™ Stent to the test," said Dr. Moses. "We have purposely included patients who represent some of the more challenging cases an interventional cardiologist is likely to encounter in everyday practice, and we are seeing excellent results. Obtaining data on a widely variable patient population, such as this, is critical to establishing meaningful economic endpoints to support the request and need for incremental reimbursement."
The SIRIUS population includes a high percentage of patients at more significant risk of restenosis, including diabetics (28%); patients with hyperlipidemia (72%), hypertension (70%), multivessel disease (42%); and patients who have previously undergone percutaneous coronary interventions or coronary artery bypass surgery (37%).
Dr. Moses noted that at 9-month clinical follow-up, there was a 72% reduction in target lesion revascularization (TLR) rate in the treatment arm versus the control. The TLR cases in the CYPHER™ Stent treatment group were almost exclusively due to disease at the stent margins, even though this phenomenon was considerably less frequent in the CYPHER™ Stent group than in the control group.
"The low TLR rate in this population is remarkable, especially when you consider the size and complexity of the study population," said Dr. Moses.
SIRIUS investigators report excellent safety results for the CYPHER™ Sirolimus-eluting Stent. At 9-month follow-up, the event-free survival rate was 90.8% in the sirolimus-treated cohort versus 80.6% in the control group (p=0.009).
There were no cases of acute, subacute or late thrombosis in the sirolimus-eluting stent arm of the study, despite only 3 months of anti-platelet therapy and the placement of overlapping stents in a significant number of patients (27%).
The CYPHER™ Sirolimus-eluting Stent, which is an investigational device in the U.S., received CE Mark approval in April and is now available in Europe. Cordis licensed the drug, sirolimus**, from Wyeth Pharmaceuticals for delivery of the drug via a stent. Cordis chose sirolimus for its cytostatic, rather than cytotoxic, properties, thereby inhibiting cell proliferation (cytostatic), rather than killing the cells (cytotoxic).
Since its establishment in 1959, Cordis Corporation, along with its subsidiaries, has been a pioneer in circulatory disease management, and is the world's largest, most comprehensive developer and manufacturer of innovative products for interventional medicine, minimally invasive computer-based imaging, and electrophysiology.
In 1994, Cordis Corporation pioneered the coronary artery stent for elective treatment of coronary artery disease. In 1996, Cordis Corporation merged with Johnson & Johnson to form Cordis Corporation, a Johnson & Johnson company, with approximately 5,300 employees worldwide.
*RAVEL (RAndomized Study with the Sirolimus-eluting VELocity Balloon-Expandable Stent), which was initiated in 2001, involves 238 patients at 19 centers in Europe and Latin America.
**Sirolimus, the active drug released from the stent, is a naturally occurring antibiotic marketed by Wyeth Pharmaceuticals, a unit of Wyeth (NYSE:WYE), under the name Rapamune and used to prevent renal transplant rejection. Cordis has entered into an exclusive worldwide license agreement with Wyeth for delivery of sirolimus via a stent. Rapamune is a trademark of Wyeth Pharmaceuticals.
Note: The CYPHER™ Sirolimus-eluting Stent is an investigational device limited by federal (U.S.) law to investigational use in the United States.