The First Clinical Trial of Antioxidant, Carvedilol-Eluting Stent in Coronary Artery Diseases

ABSTRACT

BACKGROUND AND OBJECTIVES: Carvedilol is a beta- and alpha-receptor blocker, a direct inhibitor of smooth muscle cell proliferation and migration, and it produced a significant suppression of neointimal hyperplasia in our porcine experiment. The purpose of the study was to investigate the safety and efficacy of carvedilol-eluting BiodiVysio stent implantation for de novo lesions. SUBJECTS AND METHODS: We performed a prospective randomized trial to compare two types of stents for revascularization in 39 patients [Group I (carvedilol-eluting stent) n=20, 58.3+/-11.1 years, and Group II (control stent) n=19, 59.9+/-8.5 years]. The primary effective end points were major adverse cardiac events (MACE) cardiac death, acute myocardial infarction, target lesion revascularization (TLR), in-stent restenosis and late lumen loss at the one-year clinical and angiographic follow-up. RESULTS: All the stents were successfully deployed and the patients were discharged without experiencing any clinical events. The baseline clinical characteristics, baseline diameter stenosis and minimal luminal diameter were not different between the two groups. The follow-up diameter stenosis and late loss were significantly lower in the group I compared with group II (23.1+/-12.7% vs. 47.3+/-23.6%, p=0.012; and 0.52+/-0.26 mm vs. 1.12+/-0.67 mm; p=0.020, respectively). There were no TLR and MACE in group I; however the differences were not significant [0% (0/20) vs. 10.5% (2/19); p=0.231 and 0% (0/20) vs. 15.8% (3/19), p=0.106, respectively]. CONCLUSION: Carvediloleluting stents appear feasible to use and they may be effective in the prevention of coronary restenosis. These results warrant further confirmation with a large, randomized multi-center trial.