OBJECTIVES: This study was designed to test the efficacy and safety of a fibrin-film-covered stent compared with that of a bare metal stent in the porcine @entity301 model. BACKGROUND: Biodegradable stents are a potential method of achieving total lesion coverage and delivering local, lesion-specific drug therapy. METHODS: Two coronary arteries in each @entity1707 were randomly assigned to deployment of either a fibrin-film or a bare @entity11608 wire-coil stent. An @entity130 , 1.15 to 1.30 times the reference vessel diameter, was induced in each coronary segment before stenting to simulate @entity130 . Thirty @entity1707 were studied: group 1 for 28 days (15 @entity1707 ); group 2 for 90 days (5 @entity1707 ); group 3 for 6 months (5 @entity1707 ); group 4 for 1 year (5 @entity1707 ). RESULTS: Two @entity1707 died of occlusion of the bare stent and one of occlusion of the fibrin stent (p > 0.99). There were no significant differences between the fibrin-stented and bare-stented coronary segments with regard to @entity1317 . In group 1 (28 days, 14 @entity1707 ), the mean neointimal thicknesses in the fibrin-stented and bare-stented groups were 0.57+/-0.31 and 0.57+/-0.27 mm, respectively (p=0.89). In groups 2 to 4 (90 days, four @entity1707 ; 6 months, four @entity1707 ; 1 year, five @entity1707 ), the mean neointimal thicknesses for fibrin- and bare-stented coronary segments at the times studied were 0.48+/-0.26 versus 0.50+/-0.22 mm at 90 days; 035+/-0.04 versus 0.35+/-0.16 mm at 6 months; and 0.33+/-0.14 versus 0.30+/-0.14 mm at 1 year (p=0.98). CONCLUSIONS: Fibrin-film stents appear to be an excellent candidate for local drug delivery because they can completely and safely cover the stented coronary segment while degrading slowly over 1 to 3 months. This result is important when compared with the poor results of previous studies of synthetic polymer stents.

Fibrin-film stenting in a porcine XXXX model: efficacy and safety compared with uncoated stents.

@entity1707 :: ('9823', 'Species') :: ['pigs', 'pig'] @entity301 :: ('MESH:D003327', 'Disease') :: ['coronary injury'] @entity1317 :: ('MESH:D057772', 'Disease') :: ['arterial injury'] @entity11608 :: ('MESH:D013635', 'Chemical') :: ['tantalum'] @entity130 :: ('MESH:D014947', 'Disease') :: ['angioplasty injury', 'oversized balloon injury']
@entity301 :: (MESH:D003327,Disease) :: ['coronary injury']
