Background
Short-term intraluminal application of paclitaxel via balloon catheters emerges as a new treatment option where stent implants are undesired (in-stent restenosis, bifurcations, SFA). It has been recently shown that balloons coated with paclitaxel alone are inferior to balloons coated with hydrophilic excipients plus paclitaxel in terms of neointima inhibition [1]. The present animal trial aimed to investigate whether the addition of a second antiproliferative drug to antiproliferative paclitaxel can further enhance neointima inhibition of drug-coated balloons.
Methods
We spray-coated wrapped balloon catheters (WOMBAT® platform) either with pure paclitaxel or the proprietary DiPac® coating to attain a device surface concentration for paclitaxel of 3 μg/mm 2 . The devices were tested in two porcine models: In an acute model, we compared nine paclitaxel-coated devices vs. 12 DiPac®-coated devices. Coronary arteries of seven domestic pigs were stented with bare metal stents and subsequently treated with the wrapped drug-coated balloons in a randomized fashion. After the procedure, animals were sacrificed, and the hearts were rapidly excised to assess the paclitaxel contents in the arterial tissue. In a chronic model, we treated three domestic pigs with four uncoated devices vs. four DiPac®-coated devices in a randomized fashion to further assess the efficacy of the coating. Index procedures were done as described above. After 28 days, the treatment was controlled by OCT imaging and histology.
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