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IN.PACT™ Admiral™ drug-coated balloons in peripheral artery disease: current perspectives

机译:IN.PACT™Admiral™药物涂层球囊在外周动脉疾病中的应用:当前观点

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摘要

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.
机译: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(骨病变短(<25 cm)的患者。最新指南建议在股short骨短病变中使用药物洗脱装置(药物涂层球囊[DCB]和药物洗脱支架),作为IIb类推荐。对于支架内再狭窄病变(IIb类),也建议使用DCB。 DCB是一种更具吸引力的治疗选择,因为缺乏金属假体可在将来的治疗选择中提供更大的灵活性,包括选择不使用支架的区域,即再次用DCB进行DCB治疗的区域。 IN.PACT™Admiral™DCB在数项随机对照试验和全球注册中均显示出令人鼓舞的临床表现,目前是治疗股pop病变的DCB市场领导者,迄今已治疗200,000多名患者。目前,有十多个DCB已获得ConformitéEuropéene标志,用于治疗股pop动脉粥样硬化疾病。其中的三个(包括IN.PACT海军上将DCB)也在美国获得了食品药品监督管理局的批准。但是,某些欧洲标准的ConformitéEuropéene标记的DCB在临床研究中未能显示出一致的结果,表明并非所有DCB都是相同的。每个DCB都是唯一的(即药物类型,药物剂量,结晶度和赋形剂),具有不同的临床结果。在当前的审查中,我们将不仅关注IN.PACT海军上将DCB的临床前和临床结果,还将关注其他当前可用的DCB的临床前和临床结果。

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