The multicenter trial included 384 patients with in-stent restenosis who were enrolled between February 2003 and July 2004 at 26 academic and community centers. Follow-up continued until June 2005. Patients were randomized to VBT (n = 125) or the sirolimus-eluting stent (n = 259).
Major adverse cardiac events in or out of the hospital were markedly different at 270 days (19.2 percent for the VBT group vs. 10.0 percent for the sirolimus-eluting stent group). The difference in the rate of target lesion revascularization was 19.2 percent in the VBT group vs. 8.5 percent in the sirolimus-eluting stent group. There also was a significant difference in the primary trial end point of target vessel failure (21.6 percent in the VBT group vs. 12.4 percent in the sirolimus-eluting stent group). The angiographic restenosis rate was 29.5 percent for the VBT group vs. 19.8 percent for the sirolimus-eluting stent group. Compared with the VBT group, minimal lumen diameter (size of the opening inside the vessel through which the blood flows) was larger in the sirolimus-eluting stent group at 6-month follow-up.
"In conclusion, in-stent restenosis following bare-metal stent placement remains a significant clinical problem. While vascular brachytherapy remains the only approved therapy for this condition, the results of this study indicate that the sirolimus-eluting stent is superior to vascular brachytherapy at 9 months. Angiographic measurements indicate that while both methods are effective at suppressing neointimal hyperplasia [abnormal increase in cells on vessel wall], the sirolimus-eluting stent yields greater benefits from acute gain due to the stent component of the device and from the absence of edge restenosis. This study suggests that the sirolimus-eluting stent is a safe and effective treatment for in-stent restenosis occurring within bare-metal stents," the authors write.
(JAMA. 2006;295:1264-1273. Available pre-embargo to the media at www.jamamedia.org )
Editor's Note: Funding for this study was provided by the Cordis Corporation (Warren, N.J.), a Johnson & Johnson Company. For the financial disclosures of the authors, please see the JAMA article.
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