Evaluation of drug release from paclitaxel + hirudin-eluting balloons and the resulting vascular reactivity in healthy pigs.

This study explored drug release from paclitaxel + hirudin-eluting balloons in a healthy pig coronary artery model and objectively evaluated the vascular reactivity after balloon intervention. A total of 12 healthy white pigs were used for the analysis of drug release from the experimental balloon. The observational time-points included immediately following implantation and day 7, 30, and 180 after surgery. At each time-point, two pigs were treated with the paclitaxel + hirudin-eluting balloon and one with the B. Braun paclitaxel-eluting balloon (control). Quantitative coronary angiography (QCA) of the target vessel was performed before and after balloon treatment. One pig died before the designated experimental endpoint, and no abnormal clinical signs or tissue lesions were observed in the other pigs. QCA showed different degrees of spasms after balloon treatment, all of which recovered shortly thereafter without intervention. The blood vessel lumens were all open and without dissection or angioma. Drug content determination showed that the experimental balloon performed better than the control balloon with regard to drug release, vascular absorption and expulsion rate. The paclitaxel + hirudin-eluting balloon catheter was easy to manipulate. The drug release from the experimental balloon was stable and resulted in good vascular reactivity. The safety and efficacy of the experimental balloon were not worse than the paclitaxel-eluting balloon that is currently on the market.