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

Background: Drug-coated stents may treat both mechanisms of restenosis, namely, geometric remodeling and neointimal hyperplasia. Paclitaxel, an antimicrotubule agent, has been shown to inhibit smooth muscle cell proliferation and migration, and may be an excellent candidate for local elution from a stent platform. Methods: To study the antirestenosis effects of drug-coated stents, we impregnated paclitaxel (175-200 μg/stent with programmed elution over 6 months) on Gianturco-Roubin® II (GR®II) stents. These stents and control stents without drugs were implanted in porcine coronary arteries (stent/artery approx. 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 reduced in-stent restenosis compared with the controls (51 ± 27 versus 27 ± 27% diameter stenosis, P < 0.05 and 669 ± 357 versus 403 ± 197 μm neointimal thickness, P < 0.05). This study further confirmed the biocompatibility of the polymer, with no foreign body reaction in any of the groups. Conclusions: This study shows that the paclitaxel-coated stents significantly reduced in-stent restenosis without eliciting inflammation.