Medical Clinic II, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
EuroIntervention. 2011 Oct 30;7(6):730-7. doi: 10.4244/EIJV7I6A116.
The vascular effects of drug- eluting balloon (DEB) deployment in the absence of coronary stents have not been characterised. This study evaluated potential vascular effects of paclitaxel-coated angioplasty balloons using different excipients in the absence of additional stents.
A total 45 porcine arteries were treated with paclitaxel-coated DEBs using four different excipients (all 3.0 µg/mm2): A) iopromide (n=9), B) ATEC excipient (n=8), C) BTHC excipient (n=10), D) lecithine excipient (n=10). Uncoated bare angioplasty balloons served as controls (n=8). Histology, histomorphometry, and quantitative angiography analysis were performed 28 days following intervention. Tissue concentrations of paclitaxel were measured in selected animals using BTHC excipient (n=39 arteries) and reached maximum concentrations of 165 ng/mg 30 min after delivery in coronary target tissue. There were no differences in efficacy endpoints using histomorphology or quantitative angiography between groups. In contrast, however, treatment with DEBs using BTHC excipient or iopromide was associated with increased fibrin deposition and inflammation indicating delayed vascular healing. DEBs using lecithin excipient or uncoated angioplasty balloons did not induce any comparable vascular effects.
Effective excipients are necessary to accomplish successful balloon facilitated paclitaxel delivery, which is associated with delayed vascular healing as a sign of successful drug transfer. The potential of DEBs to diminish restenosis following angioplasty may be insufficient in the absence of additional stents.
在没有冠状动脉支架的情况下，药物洗脱球囊（DEB）扩张的血管效应尚未得到描述。本研究评估了在没有额外支架的情况下，使用不同赋形剂的紫杉醇涂层血管成形球囊的潜在血管效应。
总共对 45 个猪动脉进行了紫杉醇涂层 DEB 治疗，使用了四种不同的赋形剂（均为 3.0μg/mm2）：A）碘普罗胺（n=9）、B）ATEC 赋形剂（n=8）、C）BTHC 赋形剂（n=10）、D）卵磷脂赋形剂（n=10）。未涂层的裸血管成形球囊作为对照（n=8）。干预后 28 天进行组织学、组织形态计量学和定量血管造影分析。在选定的动物中使用 BTHC 赋形剂（n=39 条动脉）测量紫杉醇的组织浓度，在冠状动脉靶组织中 30 分钟后达到 165ng/mg 的最大浓度。在组织形态学或定量血管造影的疗效终点方面，各组之间没有差异。然而，与使用卵磷脂赋形剂或未涂层血管成形球囊的 DEB 治疗相反，BTHC 赋形剂或碘普罗胺治疗与纤维蛋白沉积和炎症增加有关，表明血管愈合延迟。使用卵磷脂赋形剂或未涂层血管成形球囊的 DEB 不会引起任何类似的血管效应。
有效的赋形剂是成功完成球囊辅助紫杉醇递送所必需的，这与成功药物传递的血管愈合延迟有关。在没有额外支架的情况下，DEB 减少血管成形术后再狭窄的潜力可能不足。
