BACKGROUND: Recently we have demonstrated that abciximab (ReoPro짰)-coated stent has inhibitory effect on coronary restenosis. OBJECTIVES: The aim of this study was to investigate the beneficial effects of abciximab-coated stent on two-year clinical outcome after stent implantation. METHODS: We performed a prospective, randomized trial to compare the effects of abciximab-coated stent, which was implanted for 95 patients, with those of control stent, which was implanted for 93 patients for de novo coronary lesions. We evaluated the major adverse cardiac events (MACE; cardiac death, non-fatal myocardial infarction, and target vessel revascularization) at two-year follow-up. RESULTS: All abciximab-coated and control stents were deployed successfully. Two-year follow-up was completed in 82 patients (86%) in abciximab-coated stent group and in 82 patients (88%) in control stent group. Although there were no significant differences in the incidences of cardiac death (0% vs. 1.1%, p=0.3) and target vessel revascularization (16% vs. 21%, p=0.4) between both groups, there was a trend of lower incidences of nonfatal myocardial infarction (0% vs. 2.3%, p=0.16) and total MACE (16% vs. 24%, p=0.19) in abciximab-coated stent group compared with control stent group at two-year follow-up. Moreover, stent thrombosis did not occur in abciximab-coated stent group at two-year follow-up. Intravascular ultrasound analysis showed that lumen area was larger (5.70짹1.59 mm2 vs. 4.23짹0.77 mm2, p<0.001) and there was a trend toward smaller neointimal area (1.99짹1.62 mm2 vs. 2.62짹1.68 mm2, p=0.2) in abciximab-coated stent group compared with control stent group. CONCLUSIONS: Although abciximab-coated stent did not improve target vessel revascularization rate, it tended to inhibit neointimal hyperplasia and lower total MACE without occurrence of cardiac death, myocardial infarction, and stent thrombosis at two-year follow-up after stent implantation.