1 CVPath Institute, Inc, Gaithersburg, MD, USA.
2 Cook Research Incorporated, West Lafayette, IN, USA.
J Endovasc Ther. 2018 Feb;25(1):118-126. doi: 10.1177/1526602817743747. Epub 2017 Nov 21.
To compare the safety of Zilver PTX drug-eluting stents (DES) following drug-coated balloon (DCB) angioplasty or conventional balloon angioplasty (BA) in a healthy porcine iliofemoral artery model.
DES implantation following DCB (DCB+DES) or BA (BA+DES) was assessed by angiography and histology in the nondiseased iliofemoral arteries of 20 animals, with sacrifice at 1, 3, and 6 months. Safety assessment compared quantitative measures of vessel integrity (eg, preservation of artery geometry, structure, and lumen dimensions; absence of aneurysm; malapposition) and histological parameters (eg, excessive inflammation). The percentage of uncovered struts could not be >30% per section and the endothelial cell loss had to be <50%. The vascular and skeletal muscle changes in the downstream regions were also assessed histologically for evidence of emboli.
No significant differences in safety parameters, including inflammation and endothelial cell loss, were observed between the 2 groups at all time points. Percentage of fibrin was significantly higher in DCB+DES at 3 months [20.0% (IQR 11.6, 28.4) vs BA+DES 4.2% (IQR 1.4, 9.6), respectively; p=0.04], with consistent trends between groups at all time points. Medial smooth muscle cell loss peaked at 1 month and was not statistically different between groups at any time point, although the loss was greater in the DCB+DES group. Sections with arterioles exhibiting paclitaxel-associated fibrinoid necrosis in downstream tissues were observed exclusively in the DCB group at 1 month (14.3% of sections) and 3 months (11.5%).
This preclinical study suggests that Zilver PTX stent implantation is a safe strategy after DCB angioplasty and might be considered for patients who require stenting after DCB treatment.
比较在健康猪髂股动脉模型中，药物涂层球囊（DCB）血管成形术后和传统球囊血管成形术后（BA）使用 Zilver PTX 药物洗脱支架（DES）的安全性。
在 20 只动物的非病变髂股动脉中，通过血管造影和组织学评估 DES 植入后 DCB（DCB+DES）或 BA（BA+DES）的情况，在 1、3 和 6 个月时进行处死。安全性评估比较了血管完整性的定量测量（例如，保持动脉几何形状、结构和管腔尺寸；无动脉瘤；贴壁不良）和组织学参数（例如，过度炎症）。每个节段的未覆盖支架比例不得超过 30%，内皮细胞丢失率必须低于 50%。还通过组织学评估下游区域的血管和骨骼肌变化，以评估有无栓塞的证据。
在所有时间点，两组之间在安全性参数（包括炎症和内皮细胞丢失）方面均无显著差异。在 3 个月时，DCB+DES 中的纤维蛋白百分比明显更高[20.0%（IQR 11.6，28.4）与 BA+DES 的 4.2%（IQR 1.4，9.6）；p=0.04]，且两组之间在所有时间点均存在一致的趋势。中膜平滑肌细胞丢失在 1 个月时达到峰值，且在任何时间点两组之间均无统计学差异，尽管 DCB+DES 组的丢失更大。在 1 个月（14.3%的节段）和 3 个月（11.5%）时，仅在 DCB 组的下游组织中观察到具有紫杉醇相关纤维蛋白样坏死的小动脉节段。
这项临床前研究表明，Zilver PTX 支架植入是 DCB 血管成形术后一种安全的策略，可能适用于需要 DCB 治疗后支架置入的患者。
