Tepe Gunnar, Gögebakan Özlem, Redlich Ulf, Tautenhahn Jörg, Ricke Jens, Halloul Zuhir, Meyer Dirk-Roelfs, Waliszewski Matthias, Schnorr Beatrix, Zeller Thomas, Müller-Hülsbeck Stefan, Ott Ilka, Albrecht Thomas
Department of Radiology, RoMed Klinikum Rosenheim, Pettenkoferstr. 10, 83022, Rosenheim, Germany.
Department of Radiology and Interventional Radiology, Vivantes Hospital Berlin Neukölln, Berlin, Germany.
Cardiovasc Intervent Radiol. 2017 Oct;40(10):1535-1544. doi: 10.1007/s00270-017-1713-2. Epub 2017 Jun 28.
Based on a novel paclitaxel-resveratrol drug matrix, the safety and efficacy to inhibit intimal hyperplasia were studied in symptomatic claudicants with morphologically challenging lesions.
The treatment of peripheral artery occlusive disease (PAOD) with percutaneous transluminal angioplasty is limited by occurrence of vessel recoil and neointimal hyperplasia. Drug-coated balloons (DCB) deliver drugs to the arterial wall to potentially reduce the restenosis rate. A number of paclitaxel-coated balloon technologies are available to treat peripheral lesions.
In this randomized controlled trial, a total of 153 patients with symptomatic PAOD in femoro-popliteal lesions were randomized either to DCB or plain old balloon angioplasty (POBA).
The mean lesion length was 13.2 ± 10.4 cm with target lesion total occlusions in 26.1% of all patients (40/153). The primary endpoint of in-lesion late lumen loss (LLL) at 6 months was significantly reduced in the DCB group as compared to the POBA group (0.35 mm CI [0.19; 0.79 mm] vs. 0.72 mm CI [0.68; 1.22 mm], p = 0.006). At 12 months, the TLR rate in the DCB group was significantly lower as compared to the POBA group (17.8 vs. 37.7% p = 0.008). The censored walking distance increase suggests a benefit for patients who underwent DCB angioplasty as compared to the standard POBA treatment (12 months 165 ± 105 vs. 94 ± 136 m, p = 0.012).
The use of paclitaxel-resveratrol-matrix-coated peripheral balloon angioplasty as compared to POBA was associated with significantly reduced in-lesion LLL and reduced TLR rates. ClinicalTrials.gov identifier NCT01970579.
基于一种新型紫杉醇 - 白藜芦醇药物基质，研究其在具有形态学挑战性病变的症状性间歇性跛行患者中抑制内膜增生的安全性和有效性。
经皮腔内血管成形术治疗外周动脉闭塞性疾病（PAOD）受到血管回缩和新生内膜增生的限制。药物涂层球囊（DCB）将药物输送到动脉壁以潜在降低再狭窄率。有多种紫杉醇涂层球囊技术可用于治疗外周病变。
在这项随机对照试验中，总共153例股腘病变的症状性PAOD患者被随机分为接受DCB或普通球囊血管成形术（POBA）。
平均病变长度为13.2±10.4厘米，所有患者中有26.1%（40/153）的靶病变完全闭塞。与POBA组相比，DCB组6个月时病变内晚期管腔丢失（LLL）的主要终点显著降低（0.35毫米，95%置信区间[0.19；0.79毫米]对0.72毫米，95%置信区间[0.68；1.22毫米]，p = 0.006）。在12个月时，DCB组的靶病变血运重建（TLR）率显著低于POBA组（17.8%对37.7%，p = 0.008）。截尾步行距离增加表明与标准POBA治疗相比，接受DCB血管成形术的患者有获益（12个月时为165±105对94±136米，p = 0.012）。
与POBA相比，使用紫杉醇 - 白藜芦醇基质涂层的外周球囊血管成形术与病变内LLL显著降低和TLR率降低相关。ClinicalTrials.gov标识符：NCT01970579。
