ABSTRACT
BACKGROUND AND OBJECTIVES: Heavy metal ions released from a stainless steel stent can induce an inflammatory reaction that might be associated with in-stent restenosis. A carbon ion implantation technique, which physically integrates carbon ions into the surface of the stainless steel lattice, can block heavy metal ion diffusion, and improve the biocompatibility. This study was designed to evaluate the efficacy of a carbon ion implanted Arthosinert stent on the reduction of in-stent restenosis and the improvement in the clinical outcomes. SUBJECTS AND METHODS: 193 de novo coronary lesions in 191 anginal patients at 14 centers, with reference diameters from 2.75 to 4.5 mm, were randomly assigned to either an Arthosinert (100 patients, 102 lesions) or an Arthos (91 patients, 91 lesions) stent. The lesion length was 14.1+/-5.7 mm. The ACC/AHA (American College of Cardiology/American Heart Association) lesion classifications were A:15.0%, B1:36.8%, B2:35.8% and C:12.4%. The study end points are angiographic restenosis, during a six-month follow-up, and Major adverse cardiac event. In-stent restenosis was defined as a diameter of stenosis > or =50%. RESULTS: A six-month angiographic follow-up was obtained for 72.3% (138/191) of the subjects. There were no significant differences between the Arthosinert and Arthos groups in the rates of restenosis (17.8% vs. 31.8%, p=0.055) and Target vessel revascularization (7.0% vs. 11.0%, p=0.476). There were no deaths or non-fatal myocardial infarction in either group. CONCLUSION: The treatment of de novo coronary stenosis, with carbon ion implanted stents, showed a tendency for lower six-month angiographic restenosis rates than the conventional 316L stainless steel stents. A larger trial will be needed to confirm the efficacy of the carbon ion implanted stent.
Subject(s)
Humans , Carbon , Classification , Constriction, Pathologic , Coronary Restenosis , Coronary Stenosis , Diffusion , Follow-Up Studies , Heart , Ions , Myocardial Infarction , Stainless Steel , StentsABSTRACT
BACKGROUND AND OBJECTIVES: The transradial approach for coronary intervention has a lower incidence of access site complications and can increase patient comfort after percutaneus tansluminal coronary angioplasty(PTCA). The purpose of this study is to compare procedural success and complication rates of percutaneous transradial coronary stenting which was performed by four operators in two hospitals with those using transfemoral approach. MATERIALS AND METHOD: From September 1998 to July 1999, one hundred seventy five consecutive patients(201 lesions) treated with coronary stent implantation were enrolled for this study : 84 patients underwent transradial coronary stenting(Radial Group), and 91 patients transfemoral coronary stenting(Femoral Group). RESULTS: Seven patients who failed coronary cannulation via radial artery were crossed over to the Femoral Group. The measurements of the radial artery were not done. Patient demographics were similar in both groups. Procedural success was similar in both group(95.2% in Radial Group vs. 97.8% in Femoral Group, p=S). All transradial coronary stenting were possible using conventional guiding catheters which are used in transfemoral intervention. Local vascular complication rates showed a trend toward a reduction in the Radial Group(2.4% vs. 8.8%, p=.06). CONCLUSION: This study showed the similarity in the safety and efficacy of transradial coronary stenting compared to those of transfemoral approach.