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Background/Aims: Carvedilol is an antioxidant that inhibits smooth muscle cell proliferation and migration. The aim of this study was to investigate the beneficial effects of carvedilol-loaded stents on 2-year clinical outcomes after stent implantation in patients with coronary artery disease. Methods: We performed a prospective trial with male subjects to compare the safety and effects of carvedilolloaded BiodivYsio^® stents implanted into 20 patients with those of bare-metal BiodivYsio^® stents implanted into21 patients for de novo coronary lesions. The primary end point was the degree of neointimal hyperplasia, which was measured by intravascular ultrasound (IVUS) 6 months after the procedure; the econdary end point was major adverse cardiac events (MACE) at 2 years after implantation. All carvedilol and control stents were deployed successfully. Results: A 2-year follow-up was completed for 19 patients (95%) in the carvedilol stent group and 20 patients (95%) in the control stent group. IVUS showed a trend toward a larger luminal area (6.86 ± 2.59 vs. 5.47 ± 1.52mm^2, p = 0.267), smaller neointimal area (1.34 ± 0.70 vs. 2.40 ± 1.73 mm^2, p = 0.18), and reduced net decrease in luminal area (-0.78 ± 0.97 vs. -1.89 ± 1.78 mm^2, p = 0.106) in the carvedilol stent group compared with the control stent group, respectively. There were no significant differences in the incidence of MACE (10.5 vs.30.0%, respectively, p = 0.132) between the groups at 2 years after stent implantation. Stent thrombosis did not occur in either group after 2 years. Conclusions: The carvedilol-loaded stents tended to inhibit neointimal hyperplasia without the occurrence of cardiac death, myocardial infarction, or stent thrombosis at 2-year follow-up.
