AIM:To observe the neointimal hyperplasia and to investigate the effect and mechanism of exogenous krppel-like factor 4 (KLF4) on neointimal formation induced by balloon injury. METHODS:Adenovirus vector encoding the KLF4 (pAd-KLF4) was constructed and transfected into the balloon-injured carotid artery in rat. Neointima thickening was assessed using HE staining. Expression of exogenous KLF4 and the marker genes were detected by immunohistochemistry and RT-PCR. RESULTS:pAd-KLF4 stably expressed KLF4 protein in the transfected vascular wall. Overexpression of KLF4 significantly inhibited neointimal hyperplasia induced by balloon injury. The ratio of intima-to-media area (I/M) in pAd-KLF4 group (2.48±0.38) was significantly less than that in pAd group (0.52±0.15) (P0.05). Proliferating cell nuclear antigen (PCNA) and c-Jun were significantly reduced in pAd-KLF4 group,compared with the pAd group (P0.05). CONCLUSION:Overexpression of KLF4 inhibits the phenotype remodeling of vascular smooth muscle cells and neointimal hyperplasia induced by balloon injury.