Cremers Bodo, Schmitmeier Stephanie, Clever Yvonne P, Gershony Gary, Speck Ulrich, Scheller Bruno
Department of Internal Medicine III, University of Saarland, Homburg/Saar, Germany.
Catheter Cardiovasc Interv. 2014 Dec 1;84(7):1089-98. doi: 10.1002/ccd.25296. Epub 2013 Dec 20.
Scoring balloons are particularly useful in the acute treatment of fibro-calcific, bifurcation and in-stent restenosis lesions but have not been shown to affect the restenosis rate. Conventional balloons coated with paclitaxel have recently been shown to reduce restenosis rates in certain lesion subsets, but are associated with suboptimal acute results. A novel paclitaxel-coated scoring balloon was developed to overcome these limitations.
AngioSculpt(®) scoring balloons (SB) were coated with paclitaxel admixed with a specific excipient.
Four in vitro and in vivo studies were performed: (a) loss of the drug during passage to the lesion, (b) transfer of the drug to the vessel wall; (c) inhibition of neo-intimal proliferation in porcine coronary arteries as compared to uncoated SB and the Paccocath™, and (d) evaluation of the dose-response to 1.5-12 μg of paclitaxel/mm(2) .
Drug loss during delivery to the lesion was 17% ± 8%, and transfer to the vessel wall was 9% ± 4% of dose on unused balloons. The paclitaxel-coated SB resulted in a lower late lumen loss of 0.27 ± 0.24 mm compared to 1.4 ± 0.7 mm with the uncoated SB (P = 0.001). Histomorphometry revealed larger luminal areas of 6.8 ± 1.6 mm(2) (paclitaxel-coated SB) and 5.8 ± 1.7 mm(2) (Paccocath) as compared to the uncoated SB (2.3 ± 1.5 mm(2) ; P = 0.001). No coating related adverse effects were observed on follow-up angiography or histologic examination at the treatment site or downstream myocardium.
A novel paclitaxel-coated SB leads to a significant inhibition of neointimal proliferation in the porcine coronary model.
刻痕球囊在纤维钙化、分叉及支架内再狭窄病变的急性治疗中特别有用，但尚未显示能影响再狭窄率。近期研究表明，传统的紫杉醇涂层球囊可降低某些病变亚组的再狭窄率，但其急性效果欠佳。为克服这些局限性，研发了一种新型的紫杉醇涂层刻痕球囊。
将紫杉醇与特定辅料混合后涂覆于AngioSculpt(®)刻痕球囊（SB）上。
进行了四项体外和体内研究：（a）药物输送至病变过程中的损失；（b）药物向血管壁的转移；（c）与未涂层SB及Paccocath™相比，对猪冠状动脉新生内膜增殖的抑制作用；（d）评估1.5 - 12μg紫杉醇/mm²剂量的剂量反应。
药物输送至病变过程中的损失为17%±8%，在未使用的球囊上，转移至血管壁的药物占剂量的9%±4%。与未涂层SB（晚期管腔损失为1.4±0.7mm）相比，紫杉醇涂层SB导致的晚期管腔损失更低，为0.27±0.24mm（P = 0.001）。组织形态计量学显示，与未涂层SB（管腔面积为2.3±1.5mm²）相比，紫杉醇涂层SB的管腔面积更大，为6.8±1.6mm²（紫杉醇涂层SB）和5.8±1.7mm²（Paccocath）（P = 0.001）。在治疗部位或下游心肌的随访血管造影或组织学检查中未观察到与涂层相关的不良反应。
新型紫杉醇涂层SB在猪冠状动脉模型中可显著抑制新生内膜增殖。
