Tissue Uptake, Distribution, and Healing Response After Delivery of Paclitaxel via Second-Generation Iopromide-Based Balloon Coating: A Comparison With the First-Generation Technology in the Iliofemoral Porcine Model

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• 作者：Piotr P. Buszman ; Arm ; o Tellez ; Maxwell E. Afari ; Athanasios Peppas ; Gerard B. Conditt ; Serge D. Rousselle ; Jennifer C. McGregor ; Mark Stenoien ; Greg L. Kaluza ; Juan F. Granada
• 关键词：in-stent restenosis model ; paclitaxel-coated balloon ; second-generation
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2013
• 出版时间：August, 2013
• 年：2013
• 卷：6
• 期：8
• 页码：883-890
• 全文大小：923 K

文摘

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Objectives

This study sought to evaluate vascular drug uptake, distribution and response of second-generation paclitaxel coated balloon (PCB) (Cotavance, MEDRAD Interventional, Indianola, Pennsylvania) and compare it with first-generation technology, containing identical excipient and drug concentration.

Background

Original PCB technologies displayed a heterogeneous deposition of crystalline paclitaxel-iopromide inside the balloon folds, whereas second-generation PCBs consisted of more homogeneous, circumferential coatings.

Methods

Paclitaxel tissue uptake was assessed in 20 iliofemoral arteries of a domestic swine. Vascular healing response was assessed in the familial hypercholesterolemic model of iliofemoral in-stent restenosis. Three weeks after bare-metal stent implantation, vascular segments were randomly revascularized with first-generation PCBs (n?= 6), second-generation PCBs (n?= 6), or plain balloon angioplasty (PBA) (n?= 6). At?28 days, angiographic and histological evaluation was performed in all treated segments.

Results

One-hour paclitaxel tissue uptake was 42 % higher in the second-generation PCBs (p?= 0.03) and resulted in more homogeneous segment-to-segment distribution compared with first-generation PCBs. Both angiography (percentage of diameter stenosis: second-generation 11.5 ¡À 11 % vs. first-generation 21.9 ¡À 11 % vs. PBA 46.5 ¡À 10 % ; p < 0.01) and histology (percentage of area stenosis: second-generation 50.5 ¡À 7 % vs. first-generation 54.8 ¡À 18 % vs. PBA 78.2 ¡À 9 % ; p < 0.01) showed a decrease in neointimal proliferation in both PCB groups. Histological variance of the percentage of area stenosis was lower in second-generation compared with first-generation PCBs (51.7 vs. 328.3; p?=?0.05). The presence of peristrut fibrin deposits (0.5 vs. 2.4; p < 0.01) and medial smooth muscle cell loss (0 vs. 1.7; p < 0.01) were lower in the second-generation compared with first-generation PCBs.

Conclusions

In the experimental setting, second-generation PCB showed a comparable efficacy profile and more favorable vascular healing response when compared to first-generation PCB. The clinical implications of these findings require further investigation.