Local delivery of paclitaxel using the double-balloon perfusion catheter before stenting in the porcine coronary artery

Paclitaxel is a new cancer chemotherapeutic agent that has been approved fo r clinical use in patients with a variety of different cancers. Paclitaxel inhibits cell proliferation by an action on microtubules. The aim of this s tudy was to evaluate the safety and efficacy of locally delivered paclitaxe l after coronary stent implantation. A novel double-balloon perfusion cathe ter was used to deliver the drug locally in the pig coronary artery. Twenty -seven domestic pigs underwent stent implantation of the left anterior desc ending artery. In the treatment group (n = 11), paclitaxel (10 ml;10 mu mol /l) was delivered using the double-balloon perfusion catheter prior to sten t implantation. The control group received stent implantation only (n = 16) . The animals were sacrificed 4 weeks later. Vessels were perfusion-fixed a nd morphometric analysis was performed using conventional techniques. In ad dition, the extent of injury was determined at each stent-strut area. Corre lation of local injury and neointimal thickness was evaluated by linear reg ression. Neointimal thickness (paclitaxel 1.0 +/- 0.4 vs. control 0.7 +/- 0 .3 mm), neointimal area (paclitaxel 4.1 +/- 2.2 vs. control 2.4 +/- 1.1 mm, and the lumen area (paclitaxel 2.1 +/- 1.9 vs. control 2.5 +/- 0.9 mm did not show significant differences between both groups. Medial area (3.3 +/- 2.3 vs. 1.6 +/- 0.4 mm was larger in the vessels treated with paclitaxel (P < 0.05). Linear regression failed to show any difference in the response t o injury between the two groups. Local delivery of paclitaxel with the doub le-balloon-perfusion catheter did not reduce neointima formation following stent implantation in native pig coronary arteries. (C) 2001 Wiley-Liss, In c.