Purpose: To determine the long-term dose response of novel low-dose gamma-emitting stents in a rabbit iliac artery model.
Methods and materials: Control stents (n=24) and 103Pd stents 1.0 to 4.0 mCi (n=36) were implanted in the iliac arteries of 30 New Zealand rabbits. Stents were evaluated by intravascular ultrasound (immediately post procedure and before killing) and by histomorphometry.
Results: At 26 weeks, 28 rabbits were killed, with no evidence of stent thrombosis. In the body of the stent there was a dose-response relationship with 50% inhibition of intimal hyperplasia at the highest activity compared to control stents (p=0.07) and a significant increase in intimal hyperplasia at the lowest activity (p < 0.01). At the stent edges, there was a significant reduction of lumen area at all activity levels compared to control stents, which was most prominent at the proximal stent edge. Higher-activity stents demonstrated incomplete endothelialization and immature neointimal formation.
Conclusions: Continuous low-dose-rate irradiation by gamma-emitting 103Pd stents is feasible with reduction of in-stent hyperplasia in a dose-related manner. However, significant narrowing at the stent edges, increased in-stent hyperplasia at lower activities, and incomplete vascular healing with persistence of immature neointima at higher activities are significant limitations.