The Effect of a New Carbon Stent for Preventing Restenosis-Prospective, Randomized Study for Preventing Metal Allergy

ABSTRACT

BACKGROUND AND OBJECTIVES: Metal allergy has been reported to be related to stent restenosis. Therefore, we sought to investigate the incidence of metal allergy with new carbon stent with ion implantation technique and its relationship to restenosis. SUBJECTS AND METHODS: Between April 2002 and June 2004, 128 patients (100 male, mean age 60+/-10 years) were included in this study. The clinical diagnoses of the study patients included 64 acute myocardial infarction, 24 unstable angina and 40 stable angina patients. Patients were randomly assigned to receive either an Arthos Inert Stent (the study group) or an Arthos stent (the control group), with follow-up angiography scheduled 6 months later. Three months after stent implantation, skin patch tests, for the detection of metal allergies, were performed with manganese, molybdenum, nickel and chromium. RESULTS: There were no differences between the age, genders, risk factors and multi-vessel involvement between the two groups, as well as no differences in the angiographic parameters and restenosis (p>0.05). There were no differences in the positive rates of the skin tests between the Arthos stent and Arthos Inert stent groups or between the restenosis and no-restenosis groups (p>0.05). CONSLUSION: The new carbon stent, with ion implantation, did not reduce coronary restenosis. An allergic reaction was not related to the stent technology or stent restenosis.