Paclitaxel-coated Gianturco-Roubin (R) IIAl (GR (R) II) stents reduce neointimal hyperplasia in a porcine coronary in-stent restenosis model

Background Drug-coated stents may treat both mechanisms of restenosis, name ly, geometric remodeling and neointimal hyperplasia. Paclitaxel, an antimic rotubule agent, has been shown to inhibit smooth muscle cell proliferation and migration, and may be an excellent candidate for local elution from a s tent platform, Methods To study the antirestenosis effects of drug-coated stents, we impre gnated paclitaxel (175-200 mug/stent with programmed elution over 6 months) on Gianturco-Roubin(R) II (GR(R)II) stents. These stents and control stent s without drugs were implanted in porcine coronary arteries (stent/artery a pprox. 1.1) and evaluated 4 weeks later. Results The vessel size and the stent-to-artery ratio were similar between the groups. However, at 4 weeks, the paclitaxel group had significantly red uced in-stent restenosis compared with the controls (51 +/- 27 versus 27 +/ - 27% diameter stenosis, P < 0.05 and 669 +/- 357 versus 403 +/- 197 <mu>m neointimal thickness, P < 0.05). This study further confirmed the biocompat ibility of the polymer, with no foreign body reaction in any of the groups. Conclusions This study shows that the paclitaxel-coated stents significantl y reduced in-stent restenosis without eliciting inflammation. Coron Artery Dis 12:513-515 (C) 2001 Lippincott Williams & Wilkins.