Background: Drug eluting stents (DES) are unique in allowing sustained release for weeks after a single short intervention. The challenge with DES still remaining is the combination of a biocompatible drug-eluting matrix including an antiproliferative drug showing efficacy and safety in restenosis prevention. The aim of the present animal studies was to evaluate the novel paclitaxel coated Coroflex. Please stent in the porcine coronary model.
Methods and results: Stents were implanted into LAD and CX arteries of 49 domestic pigs. After 5 days, 4 weeks, 3 months, or 6 months, the animals underwent control angiography including dissection of the stented coronary arteries for histology. After 5 days, 3 and 6 months the Coroflex. Please stent was compared with its uncoated counterpart and a paclitaxel free but polymer coated version. After 28 days, an additional group received the Taxus Express(2) stent. After 5 days, healing with the paclitaxel coated stent was comparable to the uncoated bare metal stent as reflected in a similar neointimal proliferation. Compared to the Taxus stent, the new Coroflex. Please stent showed a similar neointimal proliferation after 4 weeks. Inflammatory reaction was comparable among the bare stent and polymer coated stent groups. Paclitaxel coating was associated with a slightly increased inflammatory reaction with both DES. After 3 and 6 months, all groups showed a similar neointimal proliferation and inflammatory reaction.
Conclusion: The present porcine studies demonstrate excellent safety of the new paclitaxel coated Coroflex stent in the porcine coronary stent model.