Pressure rinsing of coronary stents immediately before implantation reduces inflammation and neointimal hyperplasia

OBJECTIVES: This study evaluates whether rinsing stents with high pressure immediately before implantation minimizes stent-induced inflammation and neointimal formation. BACKGROUND: Several reports indicate that manual stent manipulation before implantation results in foreign body contamination and increased neointimal hyperplasia. METHODS: A stent-cleaning chamber was developed to rinse stents at a sustained hydrodynamic pressure of 4 atm for 10 s. Commercial pre-mounted stents were examined with different levels of manipulation: 1) untouched stents: no stent manipulation before implantation; 2) handled stents: manual stent re-crimping on the balloon; 3) rinsed stents: pressure-rinsed with the stent-cleaning chamber. In vitro surface analysis was evaluated by scanning electron microscopy. Neointimal hyperplasia and inflammation around stent struts were also assessed in the pig in-stent restenosis model. RESULTS: In vitro analysis revealed fewer contaminants on rinsed stents compared with untouched (p = 0.01) and handled stents (p < 0.001). In vivo, neointimal thickness, neointimal area and vessel percent stenosis were significantly reduced in rinsed, compared with not-rinsed, stents (p = 0.002, p = 0.007, p = 0.008 respectively). In addition, a significant reduction in the inflammatory infiltrate around struts was observed in untouched, compared with handled, stents (p = 0.04) and in rinsed, compared with not-rinsed, stents (p < 0.001). Regression analysis accounting for injury and neointimal thickness showed significant differences in slopes between "handled + not-rinsed" and "handled + rinsed" stents (p = 0.004), and between "untouched + not-rinsed" and "untouched + rinsed stents" (p = 0.037). CONCLUSIONS: Rinsing stents under high pressure immediately before coronary implantation results in less inflammation around struts and thinner neointima at 28 days in this pig model.