03:45 PM Abstract No. 388 Experimental animal study of a novel drug-coated balloon using 3.5-μg/mm2 paclitaxel coating on a cellulose-based excipient

Abstract

This was a two-stage experimental animal study investigating the safety and effectiveness (experiment A) together with the pharmacokinetic properties (experiment B) of a novel Drug-Coated Balloon (DCBn) using a 3.5 μg/mm2 paclitaxel coating on a cellulose-based excipient. In experiment A, DCBn was compared with a control non-DCB and two different DCBs available in the market. The arterial system of swine was used (12swine, 6vessels in each animal; 72treatment sites in total). Randomization was performed in a 3:1:1:1 proportion (Group DCBn: 36balloons, Group non-DCB: 12balloons, Group market-DCB1: 12balloons, Group market-DCB2: 12balloons). Optical coherence tomography was performed immediately after balloon dilatation and at 3 months. Primary endpoint was cross-sectional vessel wall area difference between baseline and 3 months. In experiment B, 38rabbits were used to assess DCBn’s pharmacokinetic properties. Two vessels were used in every animal (76 treatment sites). DCBn and market-DCB1 were used in 18 animals and 20 animals had only DCBn. Animals were euthanized at 1hour, 24hours, 7days and 28days and vascular tissue was removed. Paclitaxel tissue concentration was determined by high-performance liquid chromatography/tandem mass spectrometry. Paired median differences over baseline were -0.09mm2 for DCBn (p=0.33), +0.52mm2 for Group non-DCB (p=0.04), +0.32mm2 for Group DCB1 (p=0.14) and +0.32mm2 (p=0.33) for Group DCB2. Paclitaxel was detectable at a concentration of 0.10±0.18 ng/mg of tissue at 28days. In this experimental study, the use of this novel DCB in both animal models was safe. Additionally, a significantly less cross-sectional vessel wall area difference was observed compared to non-DCB. Paclitaxel was detectable in the vascular tissue at 28 days.