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. "S
Contact: Martin E. Schildhouse