BACKGROUND:Neointimal hyperplasia and resulting restenosis limit the long-term success of coronary stenting. Heavy metal ions induce an inflammatory and allergic reaction, and result in in-stent restenosis. However, a carbon ion-implanted surface might prevent heavy metal ions from diffusing into surrounding tissue. METHODS: 140 lesions in 140 patients with coronary lesions underwentimplantation of carbon-implanted surface stents (Arthos(inert) stent group, n=70) or control stents (Arthos stent group, n=70). The primary end point was the in-stent restenosis and the secondary end point was the value of hs-CRP at 48 h and 6 months after coronary stenting. Clinical and angiographic follow-ups were performed at 6 months. RESULTS: The rate of in-stent restenosis was lower in the Arthos(inert) stent group (15.9%, 10/63) than in the Arthos stent group (20.9%, 13/62), but there were no significant differences between both groups (p=0.56). The value of hs-CRP at 48 h was lower in the Arthos(inert) stent group (13.9+/-13.4 mg/dl) than in the Arthos stent group (24.5+/-26.0 mg/dl) with significant differences (p=0.04). However, the differences between two groups were not statistically significant at 6 months (p=0.76). CONCLUSIONS: As compared with a standard coronary stent, a carbon ion-implanted stent shows no considerable benefit for the prevention of in-stent restenosis within the range of this study. Despite all the limitations of this study, a positive effect of a carbon ion-implanted stent in reducing inflammatory reaction after coronary revascularization seems likely. Copyright (c) 2005 S. Karger AG, Basel.
RCT Entities:
BACKGROUND: Neointimal hyperplasia and resulting restenosis limit the long-term success of coronary stenting. Heavy metal ions induce an inflammatory and allergic reaction, and result in in-stent restenosis. However, a carbon ion-implanted surface might prevent heavy metal ions from diffusing into surrounding tissue. METHODS: 140 lesions in 140 patients with coronary lesions underwent implantation of carbon-implanted surface stents (Arthos(inert) stent group, n=70) or control stents (Arthos stent group, n=70). The primary end point was the in-stent restenosis and the secondary end point was the value of hs-CRP at 48 h and 6 months after coronary stenting. Clinical and angiographic follow-ups were performed at 6 months. RESULTS: The rate of in-stent restenosis was lower in the Arthos(inert) stent group (15.9%, 10/63) than in the Arthos stent group (20.9%, 13/62), but there were no significant differences between both groups (p=0.56). The value of hs-CRP at 48 h was lower in the Arthos(inert) stent group (13.9+/-13.4 mg/dl) than in the Arthos stent group (24.5+/-26.0 mg/dl) with significant differences (p=0.04). However, the differences between two groups were not statistically significant at 6 months (p=0.76). CONCLUSIONS: As compared with a standard coronary stent, a carbon ion-implanted stent shows no considerable benefit for the prevention of in-stent restenosis within the range of this study. Despite all the limitations of this study, a positive effect of a carbon ion-implanted stent in reducing inflammatory reaction after coronary revascularization seems likely. Copyright (c) 2005 S. Karger AG, Basel.
Authors: Erdem Arslan; Mustafa C Iğdil; Hilal Yazici; Candan Tamerler; Hakan Bermek; Levent Trabzon Journal: J Mater Sci Mater Med Date: 2007-10-30 Impact factor: 3.896