A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions

Background Drug coated balloons (DCB) with paclitaxel (Ptx) dose of 2-3.5 mu g/mm(2) balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products. The aim of the present preclinical trial was to investigate a novel DCB coated with 6 mu g Ptx/mm(2) in a porcine model. Methods and results The current study investigated a DCB with a novel, modified iopromide based matrix with 6 mu g Ptx/mm(2). Drug transfer to the vessel wall of peripheral arteries was compared with a dose of 3 mu g Ptx/mm(2) and two fully overlapping DCB with 3 mu g Ptx/mm(2), each. Ptx concentration in the vessel wall after drug transfer was about twice as high for balloons with 6 mu g/mm(2) (19571472 mu g/g) and two overlapping DCB with 3 mu g Ptx/mm(2), each (1287 +/- 619 mu g/g) compared to a single balloon with 3 mu g Ptx/mm(2), (787 +/- 738 mu g/g), with statistical significant differences for 1x6 mu g/mm(2) vs. 1x3 mu g/mm(2) (p = 0.017) but not for 2x3 mu g/mm(2) vs. 1x3 mu g/mm(2) (p = 0.184) and 1x6 mu g/mm(2) vs. 2x3 mu g/mm(2) (p = 0.178). The proportion of residual Ptx on balloon after treatment was similar for all groups between 6 +/- 1% and 10 +/- 3% of dose on balloon. Conclusion The dose of 6 mu g Ptx/mm(2) was successfully as well as reproducibly coated on conventional balloon catheters. Increased Ptx on balloons resulted in increased drug concentration in the vessel wall. A single balloon with 6 mu g Ptx/mm(2) seems to provide double dose compared to 3 mu g Ptx/mm(2), facilitates the procedure, and may reduce medico-economic cost compared to the use of two standard DCB.