Paclitaxel-Coated Balloon in Infrapopliteal Arteries 12-Month Results From the BIOLUX P-II Randomized Trial (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries)
Paclitaxel-Coated Balloon in Infrapopliteal Arteries 12-Month Results From the BIOLUX P-II Randomized Trial (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries)
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DOI：
10.1016/j.jcin.2015.07.011
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发表时间：
2015-10-01
影响因子：
11.3
通讯作者：
Brodmann, Marianne
中科院分区：
文献类型：
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作者：
Zeller, Thomas;Beschorner, Ulrich;Brodmann, Marianne
BIOLUX P-II的目标（BIOTRONIK首次在需要膝下动脉血运重建的受试者中进行的Passeo-18 LUX药物释放PTA球囊导管与无涂层Passeo-18 PTA球囊导管的人体研究）试验旨在比较新型紫杉醇涂层药物洗脱球囊（DEB）与无涂层球囊的安全性和有效性DEB在股腘动脉病变中显示出有希望的结果，但膝下动脉病变的数据很少。在一项随机化首次人体研究中，72例患者以1：1的比例随机分配至Passeo-18 Lux DEB（Biotronik AG，Buelach，Switzerland）（n = 36）或Passeo-18 PTA（n = 36）。计划在1、6和12个月时进行随访评估，并在6个月时进行血管造影评估。不良事件由一个独立的临床事件委员会裁定，血管造影参数进行了评估，由一个独立的核心laborator.Results的主要安全性终点（复合的全因死亡率，目标肢体大截肢，靶病变血栓形成，靶血管血运重建在30天）是0%的DEB组与8.3%的PTA组（p = 0.239）。主要性能终点（6个月时的通畅性丧失）在DEB组中为17.1%，在PTA组中为26.1%（p = 0.298），在12个月时，目标肢体的大截肢发生率为3.3%，而患者为5.6%，结论：Passeo-18 Lux DEB已被证明在膝下病变中安全有效，结局与PTA相当。(C)2015年由美国心脏病学会基金会。
OBJECTIVES The aim of BIOLUX P-II (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries) trial was to compare the safety and efficacy of a novel paclitaxel-coated drug-eluting balloon (DEB) versus an uncoated balloon (percutaneous transluminal angioplasty [PTA]) in de novo or native restenotic lesions of the infrapopliteal arteries in patients with claudication and critical limb ischemia.BACKGROUND DEB have shown promising results in femoropopliteal lesions, but data for infrapopliteal lesions are scarce.METHODS In this prospective, multicenter, randomized first-in-man study, 72 patients were randomized 1: 1 to either a Passeo-18 Lux DEB (Biotronik AG, Buelach, Switzerland) (n = 36) or Passeo-18 PTA (n = 36). Follow-up assessments were scheduled at 1, 6, and 12 months, with angiographic assessment at 6 months. Adverse events were adjudicated by an independent clinical events committee, and angiographic parameters were assessed by an independent core laboratory.RESULTS The primary safety endpoint (a composite of all-cause mortality, target extremity major amputation, target lesion thrombosis, and target vessel revascularization at 30 days) was 0% in the DEB group versus 8.3% in the PTA group (p = 0.239). The primary performance endpoint (patency loss at 6 months) was 17.1% in the DEB group versus 26.1% in the PTA group (p = 0.298), and major amputations of the target extremity occurred in 3.3% versus 5.6% of the patients at 12 months, respectively.CONCLUSIONS The Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA. (C) 2015 by the American College of Cardiology Foundation.