Statistical significance versus bare metal stents achieved in key clinical endpoints
WASHINGTON, D.C. – (October 18, 2005) – Results from a study on chronic total occlusions in the coronary arteries show positive clinical outcomes in patients treated with the CYPHER® Sirolimus-eluting Coronary Stent compared to those treated with conventional bare metal stents.
The six-month clinical and angiographic findings of the PRISON II trial (A Prospective Randomized Trial of Sirolimus-Eluting and Bare Metal Stents in Patients With Chronic Total Occlusions) were presented today at the Transcatheter Cardiovascular Therapeutics (TCT 2005) Conference.
The study, conducted in The Netherlands, included 200 patients with complete blockages in the coronary arteries, considered by physicians as among the most difficult lesions to treat in cardiology.
In-stent restenosis (reblockage in the stented area) results were 7 percent for the CYPHER® Stent patient cohort vs. 36 percent for the patients in the bare metal control arm of the study (p value=<0.001). The CYPHER® Stent also achieved statistical significance in key clinical endpoints such as target lesion revascularization (4.0 percent vs. 19.0 percent; p value= 0.001); target vessel failure (8.0 percent vs. 24 percent; p value= 0.003) and Major Adverse Cardiac Events (4 percent vs. 20 percent; p value= <0.001). In-stent late loss in the CYPHER® Stent patient cohort was 0.05 and 1.09 in the control (p value= 0.0001).
Dr. Maarten J. Suttorp, M.D. PhD, principal investigator of the PRISON II trial and interventional cardiologist from St. Antonius Hospital, Nieuwegein in The Netherlands believes the findings in these complex patient cases provide important new clinical evidence on the CYPHER® Stent.
"The results of this study demonstrate that positive outcomes can be achieved in this complex patient group," stated Dr. Suttorp. "As compared with bare metal stents, the findings of the CYPHER® Stent in chronic total occlusions are positive with a significant reduction in binary in-segment and in-stent restenosis."
Dennis Donohoe, M.D., vice president of clinical research and regulatory affairs, Cordis Corporation commented further on the results: "We are pleased with the results of this independent study and the continued strong belief in the clinical performance of the CYPHER® Stent across a broad range of patients."
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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