Background: The long-term clinical efficacy of intracoronary stenting has limited by restenosis. Carvedilol is an antioxidant that inhibits smooth muscle cell proliferation and migration. Our hypothesis is that delivery of carvedilol by the stent can prevent neointimal hyperplasia and improve long-term clinical outcome. The aim of this study was to investigate the beneficial effects of carvedilol-loaded stent on two-year clinical outcome after stent implantation. Methods and Results: We performed a prospective, randomized trial to compare the effects of carvedilol stent, which was implanted for 20 patients, with those of control stent, which was implanted for 21 patients for de novo coronary lesions. Carvedilol was loaded onto 3.0��15mm BiodivYsio짰 drug delivery stents (Biocompatibles Ltd, Farnham, UK) in concentrations of 5mg/ml, which was prepared by dissolving carvedilol powder in methanol. We evaluated the major adverse cardiac events (MACE) at two-year follow-up. All carvedilol and control stents were deployed successfully. Two-year follow-up was completed in 19 patients (95%) in carvedilol-loaded stent group and in 20 patients (95%) in control stent group. There were no significant differences in the incidences of cardiac death (0% in both groups), nonfatal myocardial infarction (0% in both groups). and target vessel revascularization (10.5% vs. 30.0%, p=0.132) between both groups at two-year follow-up after stent implantation. However, intravascular ultrasound analysis showed that there was a trend of larger lumen area (6.86짹2.59 mm2 vs. 5.47짹1.52 mm2, p=0.267), lesser net decreasing in lumen area (-0.78 짹 0.97 mm2 vs. -1.89 짹 1.78 mm2, p=0.106) and smaller neointimal area (1.34짹0.70 mm2 vs. 2.40짹1.73 mm2, p=0.18) in carvedilol-loaded stent group compared with control stent group. Stent thrombosis did not occur in both groups at two-year follow-up. Conclusions: Although carvedilol-loaded stent did not improve two-year target vessel revascularization rate, it tended to inhibit neointimal hyperplasia without occurrence of cardiac death, myocardial infarction, and stent thrombosis.