Paclitaxel Particle Distribution 3 Months After Drug-Coated Balloon Treatment　― Zemporshe^® Angioscopy Assessment ―

Drug distribution over time after treatment with a drug-coated balloon (DCB) has not been reported in the clinical setting. We observed the distribution of paclitaxel particles on the vascular wall after treatment with DCB (IN.PACT^TM Admiral^TM drug-coated balloon) using an electronic high-resolution angioscope (Zemporshe^®, OVALIS, Osaka, Japan).

A 78-year old woman underwent endovascular therapy for the chronic total occlusion of the right mid-superficial femoral artery. Zemporshe angioscopy was performed immediately after pre-dilatation with a balloon, then immediately after DCB deployment, and again at 3 months later. Angioscopy immediately after DCB deployment showed that the paclitaxel particles were tightly adhered to the vascular wall (Figure).¹ Angioscopy 3 months after DCB treatment showed small paclitaxel particles still remaining, although there was no clustering or protrusion of paclitaxel particles, and the amount of paclitaxel seemed to have decreased substantially (Figure).

Figure.

(Left) Angioscopy after drug-coated balloon (DCB) deployment showing a homogeneous distribution of paclitaxel particles. (Right) At 3 months after DCB treatment, paclitaxel particles still remained on the vascular wall.

Paclitaxel tissue concentration was decreased to 10% at 30 days in a healthy swine model according to the In.Pact Admiral DCB group.² This is the first report to demonstrate paclitaxel particles still remaining at 3 months after DCB treatment in a human atherosclerotic lesion.

Disclosures

The authors declare no conflicts of interest.

References

• 1.   Ihara M, Nojima Y, Adachi H, Kurimoto T, Okayama K, Sakata Y, et al. Distribution of paclitaxel particles on the vascular wall after drug-coated balloon treatment: Electronic high-resolution angioscopy assessment. Circ Rep 2019; 1: 240.
• 2.   Gongora CA, Shibuya M, Wessler JD, McGregor J, Tellez A, Cheng Y, et al. Impact of paclitaxel dose on tissue pharmacokinetics and vascular healing: A comparative drug-coated balloon study in the familial hypercholesterolemic swine model of superficial femoral in-stent restenosis. JACC Cardiovasc Interv 2015; 8: 1115–1123.