Studies suggest Cypher stent outperforms Taxus in some patients

By E. Janene Geiss

Philadelphia, March 13 - Cordis Corp., a subsidiary of Johnson & Johnson, announced Sunday that data from a multi-center, prospective randomized controlled clinical trial suggests that the Cypher Sirolimus-eluting coronary stent outperformed the Taxus stent in procedures involving long coronary lesions, which are considered some of the most complex blockages to treat with angioplasty.

The results from the study were presented at the American College of Cardiology conference in Atlanta, according to a company news release.

The study was designed to compare the angiographic in-segment binary restenosis rate of Cypher stents versus the Taxus stent at six months.

The study was conducted across five medical centers in Korea and included 500 patients, 250 in the Cypher arm and 250 in the Taxus arm.

Lesion length needed to be greater than 25 mm. It is estimated that long lesions such as these comprise about 20% of cases treated by interventional cardiologists, officials said.

"In this study, the Cypher stent showed better outcomes than the Taxus stent in these complex, long lesions. Patients with very long lesions are among the most difficult to treat and tend to be at higher risk of restenosis," Seung-Jung Park, principal investigator of this study and chief of interventional cardiology at ASAN Medical Center in Seoul, Korea, said in the release.

In another study announced Sunday, patients who received the Cypher stent had a significantly lower incidence of target vessel failure, defined as cardiac death, heart attack or the need to reopen the artery compared with patients who received radiation from within a vessel, officials said.

In this Cordis-sponsored trial, the Cypher stent was compared to brachytherapy for the treatment of blockage (restenosis) in patients who already have a bare metal stent. These data appeared Sunday in the Journal of the American Medical Association, officials said.

The trial is a multi-center, randomized study of 384 patients from 26 academic and community health centers in the United States. Results of this study indicate that the Cypher stent produced better outcomes than brachytherapy at nine months, officials said.

Cordis said it has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune.

Cordis is a Miami Lakes, Fla., developer and manufacturer of interventional vascular technology.

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