WASHINGTON, D.C. - (October 17, 2005) - Results from the SISR trial, a multi-center, randomized study of the CYPHER(r) Sirolimus-eluting Coronary Stent versus radiation from within a vessel (brachytherapy) in patients with bare-metal in-stent reblockage (restenosis), were presented today at the Transcatheter Cardiovascular Therapeutics (TCT).
2005) Scientific Symposium. The study showed that patients who received the CYPHER(r) Stent had a significantly lower incidence of target vessel failure (TVF) at nine months post-procedure compared with patients who received brachytherapy. The SISR trial was sponsored by Cordis Corporation, a Johnson & Johnson company.
"The efficacy and safety results from this study were significantly better in the drug-eluting stent arm of the study," said Principal Investigator David R. Holmes, Jr., M.D., Professor of Medicine at the Mayo Clinic College of Medicine. "The CYPHER(r) Stent has shown excellent results in complex patient cases and this is another example of a strong clinical performance in a category that has challenged physicians for years."
A large, multicenter, randomized study involving 384 patients, the Sirolimus-eluting CYPHER(r) Stent Versus Intravascular Brachytherapy In the Treatment of Patients with In-Stent Restenotic Coronary Artery Lesions, or SISR trial, showed the superior safety profile of the
CYPHER(r) Stent compared to intravascular brachytherapy in complex patients. The primary endpoint of the study was the incidence of TVF, defined as cardiac death, heart attack (myocardial infarction), or the need to re-open the artery (target vessel revascularization, or TVR) at nine months.
- CYPHER(r) Stent (n=259)
- Brachytherapy (n=125)
- P value
Target vessel failure
Contact: Amy Meshulam
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