Vascular Response, Downstream Effect, and Pharmacokinetics After Sirolimus- and Paclitaxel-Coated Balloons in Porcine Coronary Arteries.

Abstract

Background: Paclitaxel (PCB) and sirolimus-coated balloons (SCB) are major therapeutic options for coronary artery disease, but there is no direct head-to-head histological comparison of their effects during the percutaneous coronary intervention (PCI).

Aims: We aimed to investigate the vascular and downstream effects and drug pharmacokinetics in a porcine coronary model treated with MagicTouch-SCB (MT-SCB), Selution-SRL-SCB (SEL-SCB), Agent PCB, and plain old balloon angioplasty (POBA).

Methods: Twenty-eight coronary arteries from 10 pigs were treated with one of three drug-coated balloons (DCBs) (n = 7 for each) or POBA (n = 7) with 28 days follow-up. In six pigs, histological assessment was performed for the arterial response with semi-quantified scoring. In four pigs, sirolimus and paclitaxel concentrations were measured in the coronary artery and downstream myocardium. All 10 animals were histologically assessed for downstream effects on the myocardium for distal emboli and tissue injury.

Results: All DCBs showed minimal neointimal formation, but the MT-SCB and SEL-SCB showed less medial SMC loss compared to the PCB. In the histology section-based analysis of downstream myocardium, PCB showed evidence of myocyte necrosis/scarring in 21% of sections, whereas there was no evidence in the other groups (p < 0.01). POBA had the lowest downstream emboli (6%), followed by MT-SCB (15%), SEL-SCB (25%), and PCB (36%) (p = 0.02). In the pharmacokinetic analysis, paclitaxel showed higher concentration after PCB treatment compared to sirolimus after both two SCBs treatment in coronary and downstream myocardium.

Conclusion: MT-SCB and SEL-SCB demonstrated less arterial injury, less downstream effect, and lower drug concentration compared to PCB during PCI.