Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Orangeburg, NY, USA.
EuroIntervention. 2013 Aug 22;9(4):510-6. doi: 10.4244/EIJV9I4A82.
The routine use of paclitaxel-coated balloons (PCB) in combination with bare metal stents (BMS) in de novo coronary lesions has been questioned. In this study, we aimed to compare the vascular response of BMS implanted using a second-generation PCB (BMS+PCB) with the TAXUS stent (PES) and a BMS control (BMS) in the familial hypercholesterolaemic swine (FHS) model of coronary injury.
A total of 17 stents (PES=6, BMS+PCB=6, and BMS=5) were implanted in the coronary territory of 10 FHS using a 20% overstretch injury ratio. Imaging evaluation (QCA and IVUS) was conducted in all animals at baseline and 28 days following stent implantation. Following terminal imaging all animals were euthanised and stented coronary segments harvested for histological evaluation. At 28 days, the lowest degree of percentage diameter stenosis by QCA was achieved by the PES (2.9 ± 9%) followed by the BMS+PCB (9.5 ± 16.4%) and the BMS group (25.65 ± 18.7%, p<0.05). In histology, percentage area of stenosis (BMS+PCB=29.6 ± 6.4% vs. PES=21.5 ± 3.3% vs. BMS=55.2 ± 12.9%; p<0.01) and neointimal thickness (BMS+PCB=0.26 ± 0.1 mm vs. PES=0.21 ± 0.1 mm vs. BMS=0.59 ± 0.2 mm; p<0.01) were significantly reduced in both paclitaxel groups in comparison to BMS controls. Both BMS+PCB and BMS groups had higher endothelialisation scores (PES=1.50 ± 0.9 vs. BMS+PCB=2.73 ± 0.4 vs. BMS=3.00; p<0.05) and lower peri-strut inflammatory scores (PES=0.83 ± 0.4 vs. BMS+PCB=0.20 ± 0.2 vs. BMS=0.43 ± 0.6, p<0.05) when compared to PES. Neointima maturity (PCB+BMS: 2.00 [2-2.4] vs. PES: 1.00 [0.3-1] vs. BMS: 3.00, p<0.05) and fibrin deposition (PCB+BMS: 1.40 ± 0.3 vs. PES: 2.17 ± 0.7 vs. BMS: 0.27 ± 0.3, p<0.05) scores in PCB+BMS appeared to fall between the PES and the BMS ranges.
In the FHS coronary injury model, BMS implantation using a PCB yields a degree of neointimal inhibition comparable to the PES. The BMS+PCB combination presented lower degrees of inflammation and fibrin deposition; however, signs of delayed healing were still present.
在新出现的冠状动脉病变中，紫杉醇涂层球囊（PCB）与裸金属支架（BMS）的常规联合应用受到了质疑。本研究旨在比较第二代 PCB（BMS+PCB）与 TAXUS 支架（PES）和 BMS 对照组（BMS）在家族性高胆固醇血症猪（FHS）冠状动脉损伤模型中植入的 BMS 的血管反应。
使用 20%的过度扩张比，在 10 只 FHS 的冠状动脉区域共植入了 17 个支架（PES=6，BMS+PCB=6，BMS=5）。所有动物均在基线和支架植入后 28 天进行 QCA 和 IVUS 成像评估。在进行终末成像后，所有动物均被安乐死，并采集支架植入的冠状动脉段进行组织学评估。28 天时，QCA 显示最小的百分比直径狭窄程度由 PES 组（2.9±9%），其次是 BMS+PCB 组（9.5±16.4%）和 BMS 组（25.65±18.7%，p<0.05）。在组织学上，BMS+PCB 组的狭窄百分比面积（29.6±6.4%）与 PES 组（21.5±3.3%）和 BMS 组（55.2±12.9%）相比明显降低（p<0.01），而新生内膜厚度（BMS+PCB=0.26±0.1mm）与 PES 组（0.21±0.1mm）和 BMS 组（0.59±0.2mm）相比也明显降低（p<0.01）。与 BMS 对照组相比，BMS+PCB 组和 BMS 组的内皮化评分更高（PES=1.50±0.9 vs. BMS+PCB=2.73±0.4 vs. BMS=3.00，p<0.05），支架内炎症评分更低（PES=0.83±0.4 vs. BMS+PCB=0.20±0.2 vs. BMS=0.43±0.6，p<0.05）。与 PES 组相比，BMS+PCB 组的新生内膜成熟度（PCB+BMS：2.00[2-2.4]）和纤维蛋白沉积评分（PCB+BMS：1.40±0.3））均较低（p<0.05）。
在 FHS 冠状动脉损伤模型中，使用 PCB 植入 BMS 可达到与 PES 相当的新生内膜抑制程度。BMS+PCB 组合显示出较低程度的炎症和纤维蛋白沉积，但仍存在愈合延迟的迹象。
