紫杉醇涂层球囊在膝下动脉中的应用：BIOLUX P-II 随机试验的 12 个月结果（BIOTRONIK 首次人体研究：Passeo-18 LUX 药物洗脱球囊与未涂层 Passeo-18 PTA 球囊在需要下肢动脉血运重建的患者中的对比）
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).
机构信息
Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
coreLab Bad Krozingen GmbH, Bad Krozingen, Germany.
出版信息
JACC Cardiovasc Interv. 2015 Oct;8(12):1614-22. doi: 10.1016/j.jcin.2015.07.011.
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.
目的
BIOLUX P-II（百多力公司的首例人体研究，比较新型紫杉醇涂层药物洗脱球囊（DEB）与未涂层的 Passeo-18 PTA 球囊在需要再通治疗的下肢动脉的疗效和安全性）试验的目的是比较在有跛行和严重肢体缺血的患者中，新型紫杉醇涂层药物洗脱球囊（DEB）与未涂层球囊（经皮腔内血管成形术 [PTA]）在下肢动脉的初发或原发性再狭窄病变中的安全性和有效性。
背景
DEB 在股腘动脉病变中显示出良好的结果，但下肢动脉病变的数据很少。
方法
在这项前瞻性、多中心、随机的首例人体研究中，72 名患者按照 1:1 的比例随机分为 Passeo-18 Lux DEB（百多力公司，比拉赫，瑞士）（n=36）或 Passeo-18 PTA（n=36）。随访评估计划在 1、6 和 12 个月进行，血管造影评估在 6 个月进行。不良事件由独立临床事件委员会裁定，血管造影参数由独立核心实验室评估。
结果
主要安全性终点（30 天内全因死亡率、靶肢主要截肢、靶病变血栓形成和靶血管血运重建的复合终点）在 DEB 组为 0%，在 PTA 组为 8.3%（p=0.239）。主要疗效终点（6 个月时的通畅性丧失）在 DEB 组为 17.1%，在 PTA 组为 26.1%（p=0.298），12 个月时靶肢主要截肢分别发生在 3.3%和 5.6%的患者中。
结论
Passeo-18 Lux DEB 在下肢动脉病变中已被证明是安全有效的，与 PTA 相比具有相似的结果。
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