The multicenter trial conducted by David R. Holmes, Jr., M.D., of Mayo Clinic, Rochester, Minn., and colleagues, included 384 patients with in-stent restenosis who were enrolled at 26 academic and community centers.
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 revascularisation 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 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, 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.
MEDICA.de; Source: American Medical Association (AMA)