NEbivolol inhibition of coronary artery smooth muscle cell proliferation after percutaneous coronary artery intervention. Results of the NESCIO Study, a randomized, double blind trial.

OBJECTIVES This study compared the efficacy of metoprolol and nebivolol in reducing the frequency of in-stent restenosis (ISR) after a percutaneous coronary intervention (PCI). BACKGROUND ISR results from excessive neointimal proliferation. Nebivolol inhibits proliferation of human coronary endothelial and smooth muscle cells in vitro. Its efficacy has not been studied in clinical trials. MATERIAL AND METHODS In a single-centre double-blind study, 79 subjects with de novo lesions were randomly assigned to receive either nebivolol (n=37) or metoprolol (n=42) 3 to 7 days before elective PCI with bare metal stents. The study medication was continued for 6 months. Nebivolol was administered at 5 mg/day for 3 weeks, then at 10 mg/day. Metoprolol was administered at 100 mg/day. The endpoints were the difference in fractional flow reserve (deltaFFR) between values immediately after PCI and those at 6 months and ISR during the 6 months following PCI The study was powered to detect a deltaFFR of 6% with 30 subjects per treatment group. RESULTS Among subjects who underwent angiography at 6 months, mean deltaFFR was--0.08 for the nebivolol group (n=25) and -0.12 in the metoprolol group (n=26; p = 0.367). ISR occurred in 11 subjects (26.2%) on metoprolol and in 3 (8.1%) on nebivolol during treatment, and in 7 subjects on metoprolol and in 3 on nebivolol at 6 months (p = 0.014) CONCLUSION There was a non-significant trend toward less decline in detaFFR at 6 months with nebivolol. Nebivolol should be investigated further in larger trials. Nebivolol significantly reduced the frequency of ISR as compared to metoprolol.