Paclitaxel-releasing stent more effective than radiation therapy for preventing restenosis

Insertion of stents that release the drug paclitaxel to treat stenosis within an implanted bare-metal stent in a coronary artery reduces the risk of subsequent re-narrowing within the stent, when compared with treatment using intra-coronary radiation, according to a new study in the March 15 issue of JAMA. The study is being released early online to coincide with its presentation at the American College of Cardiology annual conference.

Gregg W. Stone, M.D., of Columbia University Medical Center, New York, and colleagues with the TAXUS V ISR trial compared the use of paclitaxel-releasing stents with vascular brachytherapy (VBT radiation therapy) in patients with in-stent restenosis (ISR renarrowing of an artery after treatment) of bare-metal stents.

According to background information in the article, VBT is the only U.S. Food and Drug Administration (FDA)-approved treatment for bare-metal coronary ISR; however, VBT is logistically complex, expensive, and associated with late thrombosis and restenosis. These limitations have resulted in a shift away from VBT for treatment of ISR in daily clinical practice despite the absence of a proven therapeutic alternative. Restenosis occurs in 10 percent to 50 percent or more of patients following implantation of bare-metal stents. Drug-eluting (releasing) stents have been demonstrated to safely reduce restenosis compared with bare-metal stents. Whether drug-eluting stents are safe and effective for treatment of ISR, however, has not been established.

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 VBT (n = 201) or paclitaxel-releasing stent implantation (n = 195). Clinical and angiographic follow-up at 9 months were scheduled in all

Contact: Craig LeMoult
JAMA and Archives Journals

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