Werk Michael, Langner Soenke, Reinkensmeier Bianka, Boettcher Hans-Frank, Tepe Gunnar, Dietz Ulrich, Hosten Norbert, Hamm Bernd, Speck Ulrich, Ricke Jens
Charité, Universitätsmedizin Berlin, Martin-Luther-Krankenhaus, Department of Radiology, Berlin, Germany.
Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.
The success of percutaneous intervention in peripheral arterial disease is limited by restenosis. The aim of the present pilot study was to evaluate a novel method of local drug delivery.
This randomized multicenter study with blinded reading enrolled 87 patients in Rutherford class 1 to 4 with occlusion or hemodynamically relevant stenosis, restenosis, or in-stent restenosis of femoropopliteal arteries. Treatment was performed by either conventional uncoated or paclitaxel-coated balloon catheters. The primary end point was late lumen loss at 6 months. Secondary end points included restenosis rate, ankle brachial index, Rutherford class, target lesion revascularization, and tolerance up to >18 months. Before intervention, there were no significant differences in lesion characteristics such as reference diameter (5.3+/-1.1 versus 5.2+/-1.0 mm), degree of stenosis (84+/-11% versus 84+/-16%), proportion of restenotic lesions (36% versus 33%), and mean lesion length (5.7 cm [0.8 to 22.6 cm] versus 6.1 cm [0.9 to 19.3 cm]) between treatment groups. The 6-month follow-up angiography performed in 31 of 45 and 34 of 42 patients showed less late lumen loss in the coated balloon group (0.5+/-1.1 versus 1.0+/-1.1 mm; P=0.031). The number of target lesion revascularizations was lower in the paclitaxel-coated balloon group than in control subjects (3 of 45 versus 14 of 42 patients; P=0.002). Improvement in Rutherford class was greater in the coated balloon group (P=0.045), whereas the improvement in ankle brachial index was not different. The difference in target lesion revascularizations between treatment groups was maintained up to >18 months. No adverse events were assessed as related to balloon coating.
In this pilot trial, paclitaxel balloon coating caused no obvious adverse events and reduced restenosis in patients undergoing angioplasty of femoropopliteal arteries.
经皮介入治疗外周动脉疾病的成功率受再狭窄限制。本初步研究旨在评估一种新型局部给药方法。
这项随机多中心研究采用盲法读数，纳入了87例卢瑟福分级为1至4级、患有股腘动脉闭塞或血流动力学相关狭窄、再狭窄或支架内再狭窄的患者。治疗采用传统未涂层或紫杉醇涂层球囊导管进行。主要终点是6个月时的晚期管腔丢失。次要终点包括再狭窄率、踝肱指数、卢瑟福分级、靶病变血运重建以及长达18个月以上的耐受性。干预前，治疗组之间在病变特征方面无显著差异，如参考直径（5.3±1.1对5.2±1.0毫米）、狭窄程度（84±11%对84±16%）、再狭窄病变比例（36%对33%）以及平均病变长度（5.7厘米[0.8至22.6厘米]对6.1厘米[0.9至19.3厘米]）。45例中的31例和42例中的34例患者进行的6个月随访血管造影显示，涂层球囊组的晚期管腔丢失较少（0.5±1.1对1.0±1.1毫米；P=0.031）。紫杉醇涂层球囊组的靶病变血运重建次数低于对照组（45例中的3例对42例中的14例患者；P=0.002）。涂层球囊组的卢瑟福分级改善更大（P=0.045），而踝肱指数的改善无差异。治疗组之间靶病变血运重建的差异持续长达18个月以上。未评估到与球囊涂层相关的不良事件。
在这项初步试验中，紫杉醇球囊涂层未引起明显不良事件，并减少了接受股腘动脉血管成形术患者的再狭窄。
