Drug eluting stents demonstrated to be an effective alternative to prevent in-stent restenosis. Inflammation plays a key role in the process of neointimal proliferation after stent implantation. Dexamethasone(DEX) is highly anti-inflammatory at low concentrations, and has immunosuppressive effects, in part through the inhibition of cytokine release. A reduced neointimal proliferation was demonstrated in a porcine model using the Biodivysio Drug Delivery PC coated stent loaded with a high dose dexamethasone. The purpose of this study is to evalulate the acute safety and efficacy of the Biodivysio DEX eluting stent implanted in patients with de novo lesions. 66 patients with de novo lesions(n=71) (<15mm long, type A/B) in native 2.75-4.0 mm vessels were enrolled up to now. One 15 mm or 18mm long Biodivysio DD PC stent was immersed in a 20mg/ml DEX solution, yielding a total DEX dose of 50㎍ per mm stent before implantation. Demographics are as follows : Mean age is 61.8 years ; 57% are male ; 40% are dialetic, and 26% and 52% hypercholesterolemic and hypertensive respectively. The stented vessels are RCA 48%, LAD 35.2%, and LCX 14.1%. The majority of lesions are type B (83%), baselnie stenosis 78.5% and post-stent residual stenosis 1.6%. 6 month clinicla and angiographic follow up results showed 7.1% MACE (5.4% TLR, 1.8% nonfatal MI) and 9.3% (4/43) restenosis rate, respectively.
Conclusions : High-dose dexamethasone eluting stent seems to be promising to prevent in-stent restenosis. larger randomised clinical trials are needed in order to support these results and extend them to more complex lesions
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