Torii Sho, Kolodgie Frank D, Virmani Renu, Finn Aloke V
Cardiovascular Pathology, CVPath Institute, Inc., Gaithersburg, MD, USA,
Med Devices (Auckl). 2019 Feb 12;12:53-64. doi: 10.2147/MDER.S165620. eCollection 2019.
Endovascular therapy has evolved as a main treatment option especially in patients with short (<25 cm) femoropopliteal lesion. The latest guideline recommends the use of drug-eluting devices (both drug-coated balloons [DCBs] and drug-eluting stents) in short femoro-popliteal lesions as class IIb recommendation. DCB usage is also recommended for in-stent restenosis lesions (class IIb). DCBs are a more attractive treatment option because the lack of metal prosthesis allows for more flexibility in future treatment options including the option of treating nonstenting zones, previously DCB-treated zones with DCBs again. The IN.PACT™ Admiral™ DCB has shown promising clinical performance in several randomized control trials and global registries, and is currently the market DCB leader for the treatment of femoropopliteal lesions with more than 200,000 patients treated thus far. Currently, more than 10 DCBs have received Conformité Européene mark for the treatment of femoropopliteal atherosclerotic disease. Three of these (including IN.PACT Admiral DCBs) have also received Food and Drug Administration approval in the USA. However, some Conformité Européene-marked DCBs have failed to show consistent results in their clinical studies suggesting all DCBs are not created equal. Each DCB is unique (ie, drug type, drug dose, crystallinity, and excipient) with different clinical outcomes. In the current review, we will focus on the preclinical and clinical results of not only IN.PACT Admiral DCB, but also the other currently available DCBs.
血管内治疗已发展成为一种主要的治疗选择，尤其是对于股腘段病变较短（<25 cm）的患者。最新指南建议，对于股腘段短病变，使用药物洗脱装置（药物涂层球囊[DCB]和药物洗脱支架）为IIb类推荐。对于支架内再狭窄病变，也建议使用DCB（IIb类）。DCB是一种更具吸引力的治疗选择，因为缺乏金属假体使得未来的治疗选择更具灵活性，包括治疗非支架区域、先前用DCB治疗过的区域再次使用DCB的选择。IN.PACT™ Admiral™ DCB在多项随机对照试验和全球注册研究中显示出了良好的临床性能，目前是治疗股腘段病变的市场领先DCB，迄今为止已治疗超过200,000例患者。目前，已有超过10种DCB获得欧洲合格认证标志，用于治疗股腘动脉粥样硬化疾病。其中三种（包括IN.PACT Admiral DCB）也已获得美国食品药品监督管理局的批准。然而，一些获得欧洲合格认证标志的DCB在其临床研究中未能显示出一致的结果，这表明并非所有DCB都是一样的。每种DCB都是独特的（即药物类型、药物剂量、结晶度和赋形剂），临床结果也不同。在本综述中，我们不仅将关注IN.PACT Admiral DCB的临床前和临床结果，还将关注其他目前可用的DCB的结果。
