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
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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DOI：
10.1016/j.jcin.2013.04.013
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发表时间：
2013-08-01
影响因子：
11.3
通讯作者：
Granada, Juan F.
中科院分区：
文献类型：
--
作者：
Buszman, Piotr P.;Tellez, Armando;Granada, Juan F.
目的评价第二代紫杉醇涂层球囊（PCB）的血管药物摄取、分布和反应（Cotavance，MEDRAD Interventional，Indianola，Pennsylvania），并将其与含有相同赋形剂和药物浓度的第一代技术进行比较。而第二代多氯联苯组成的更均匀的，圆周coatings.Methods太平洋组织的摄取进行了评估，在20髂股动脉的家猪。在髂股动脉支架内再狭窄的家族性高胆固醇血症模型中评估血管愈合反应。裸金属支架植入后3周，血管段随机采用第一代PCB（n = 6）、第二代PCB（n = 6）或普通球囊血管成形术（PBA）（n = 6）进行血运重建。在28天，血管造影和组织学评价进行了所有治疗segments.Results一小时紫杉醇组织摄取高42%，在第二代多氯联苯（p = 0.03），并导致更均匀的段到段的分布相比，第一代多氯联苯。血管造影（直径狭窄百分比：第二代11.5 +/- 11% vs.第一代21.9 +/- 11% vs. PBA 46.5 +/- 10%; p < 0.01）和组织学（面积狭窄百分比：第二代50.5 +/- 7% vs.第一代54.8 +/- 18% vs. PBA 78.2 +/- 9%; p < 0.01）显示两个PCB组的新生内膜增殖减少。与第一代多氯联苯相比，第二代多氯联苯的狭窄面积百分比的组织学差异较低（51.7 vs. 328.3; p = 0.05）。与第一代PCB相比，第二代PCB中的支架周围纤维蛋白沉积（0.5 vs. 2.4; p < 0.01）和中膜平滑肌细胞丢失（0 vs. 1.7; p < 0.01）较低。结论在实验环境中，与第一代PCB相比，第二代PCB显示出相当的疗效特征和更有利的血管愈合反应。这些发现的临床意义需要进一步研究。(C)2013年美国心脏病学会基金会
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 +/- 11% vs. first-generation 21.9 +/- 11% vs. PBA 46.5 +/- 10%; p < 0.01) and histology (percentage of area stenosis: second-generation 50.5 +/- 7% vs. first-generation 54.8 +/- 18% vs. PBA 78.2 +/- 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. (C) 2013 by the American College of Cardiology Foundation