Local delivery of paclitaxel for the prophylaxis of restenosis after experimental balloon dilatation

Abstract

Introduction: Paclitaxel is an agent with potent antitumor activity that has been approved for clinical use in patients with different types of cancers. It influences the cytoskeleton equilibrium by increasing the assembly of altered microtubules. The aim of this study was to evaluate the safety and efficacy of local delivered paclitaxel after experimental balloon dilatation.

Material and methods: Seventeen domestic pigs underwent balloon dilatation of the proximal left anterior descending artery. In the treatment group (n=8) paclitaxel (10 ml; 10 micromole/L) was delivered using the double-balloon perfusion catheter. The control group (n=9) received only physiological saline under the same circumstances. The animals were sacrificed 4 weeks later. Vessels were perfusion-fixed and histomorphometric analysis was performed using conventional techniques.

Results: The vessel lumen of the treatment group was significantly larger (2.13±1.2 mm²) than that of the control group (1.38±0.6mm²) (p<0.05). The degree of stenosis in the treatment group was significantly lower (22.2±13.2%) than that of the control group (53.7±21.5%) (p<0.05). The intimal area of the treatment group was significantly lower (0.61±0.5mm²) than that of the control group (1.78±1.0mm²)

Conclusion: The favorable features of paclitaxel for local application ant the advantageous mode of action suggest that this drug seems to be effective and safe for the prophylaxis of restenosis.