Pharmacokinetic Evaluation of Two Paclitaxel-Coated Balloons with Different Drug Load in a Short-Term Porcine Study

The aim of the study was to evaluate the pharmacokinetics and tissue absorption of 2 paclitaxel (PTX) drug-coated balloons (DCB) using different drug loads in a porcine-injured iliac artery model. Twenty-eight pigs were randomized into 2 groups. In group B1, angioplasty was performed with a 1.0 A mu g/mm(2) DCB with PTX and in group B3, with a 3.0 A mu g/mm(2) DCB with PTX. An overstretched model of the iliac artery was used for angioplasty under fluoroscopy. Blood and vessel wall PTX were measured with liquid-chromatography mass spectrometry at 1, 5, 30 min, 1, 7, and 28 days. Remaining drug in the balloon was analyzed. Mean PTX in blood was significantly higher in the group B3 0.269 +/- A 0.085 A mu g/ml compared with the B1 0.218 +/- A 0.085 A mu g/ml; p = 0.01. Peak blood PTX concentration was detected at 1 min, and PTX was undetectable 24 h post-angioplasty. There were no statistically significant differences in the mean arterial wall concentration from the treated iliac artery between group-B1 (15.24 +/- A 21.29 ng/mg) and B3 (15.68 +/- A 16.33 ng/mg), or in the PTX wall concentration measured at different time points. Mean remaining drug in assayed balloons was lower for group-B1 and represented 8 % of the initial dose. Blood PTX was higher when using 3.0 A mu g/mm(2) DCB, with a peak drug concentration at 1-min, although the drug was undetectable at 24 h, independently of the loading dose. This study demonstrates no difference in arterial wall uptake of a low dose DCB (1.0 A mu g/mm(2)), when compared to a common dose DCB (3.0 A mu g/mm(2)) suggesting that the dose of drug in the DCB could be reduced obtaining a similar clinical effect.