Drug-eluting balloon: Very short-term exposure and overlapping
Drug-eluting balloon: Very short-term exposure and overlapping
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DOI：
10.1160/th08-06-0387
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发表时间：
2009-01-01
影响因子：
6.7
通讯作者：
Scheller, Bruno
中科院分区：
文献类型：
--
作者：
Cremers, Bodo;Speck, Ulrich;Scheller, Bruno
在初始临床试验中，Paclitaxel球囊涂层显示出抑制再狭窄的良好效果。本研究的目的是评价药物洗脱球囊（DEB）应用的两个关键特征的影响-充盈时间和因重叠球囊而增加的剂量。将五十六枚不锈钢支架以1.2：1.0的过拉伸比植入28只家猪的冠状动脉左前降支和回旋支。将支架安装在传统的无涂层和紫杉醇涂层血管成形术球囊导管上。将动物随机分配至5种不同的治疗组，内膜接触时间范围为短（使用IDEB充盈10秒[s]）至长（使用2 DEB充盈2x 60秒）。28天后，对总共23只猪进行了支架动脉的定量血管造影和组织形态测定。Paclitaxel球囊涂层导致表征支架内狭窄的参数显著降低：无涂层球囊的晚期管腔丢失为1.37 +/- 0.49 mm，1个涂层球囊60 s充盈时间为0.23 +/- 0.42 mm，10 s充盈时间为0.37 +/- 0.28 mm，使用两个涂层球囊治疗的血管节段为0.30 +/- 0.19 mm，每个球囊充盈60 s。新生内膜面积分别为4.26 +/- 1.18、1.68 +/- 0.23、1.83 +/- 0.40和1.67 +/- 0.46 mm（2）（与对照组相比p=0.001，紫杉醇治疗组之间p>0.05）。尽管新生内膜增殖显著减少，但所有样品中均存在支架支柱内皮化。在试验范围内，无论充盈时间和剂量如何，DEB均能有效减少新生内膜增殖。当剂量增加到临床试验剂量的三倍以上时，未观察到不良反应。
Paclitaxel balloon coating has shown promising effects in inhibiting restenosis in initial clinical trials. The aim of the present study was to evaluate the influence of two critical features of drug-eluting balloon (DEB) application - inflation time and increased dose due to overlapping balloons. Fifty-six stainless steel stents were implanted in the left anterior descending and circumflex coronary arteries of 28 domestic pigs using a 1.2:1.0 overstretch ratio. Stents were mounted on conventional uncoated and paclitaxel-coated angioplasty balloon catheters. The animals were randomized to five different treatments with a range of short (10 seconds [s] inflation using I DEB) to extended (2x60 s inflation using 2 DEB) intima contact time. After 28 days, quantitative angiography and histomorphometry of the stented arteries was performed on a total of 23 pigs. Paclitaxel balloon coating led to a marked reduction of parameters characterizing in-stent stenosis: Late lumen loss was 1.37 +/- 0.49 mm for uncoated balloons, 0.23 +/- 0.42 mm for one coated balloon 60 s inflation time, 0.37 +/- 0.28 mm for 10 s inflation time and 0.30 +/- 0.19 mm for the vessel segment treated by two coated balloons with 60 s inflation each. Neointimal areas were 4.26 +/- 1.18, 1.68 +/- 0.23, 1.83 +/- 0.40 and 1.67 +/- 0.46 mm(2), respectively (p=0.001 versus control, p>0.05 between paclitaxel-treated groups). Despite the marked reduction of neointimal proliferation, endothelialization of stent struts was present in all samples. DEB were found to effectively reduce neointimal proliferation regardless of inflation time and dose within the tested range. No adverse reactions were seen as dose was increased to more than three times the clinically tested dose.