FDAnews
www.fdanews.com/articles/85228-paclitaxel-releasing-stent-prevents-restenosis

PACLITAXEL-RELEASING STENT PREVENTS RESTENOSIS

March 13, 2006

The paclitaxel-releasing stent is more effective than radiation therapy for preventing restenosis, according to a new study in the Journal of the American Medical Association.

The multicenter, randomized trial included 396 patients with in-stent restenosis of a previously implanted bare-metal coronary stent. The study was conducted between June 2003, and July 2004 at 37 North American academic and community-based institutions. Patients were randomly assigned to undergo angioplasty followed by vascular brachytherapy (VBT) or paclitaxel-releasing stent implantation. Clinical and angiographic follow-up at nine months were scheduled in all patients.

According to background information in the article, VBT is the only FDA-approved treatment for bare-metal coronary ISR; however, VBT is logistically complex, expensive, and associated with late thrombosis and restenosis.