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药物涂层球囊:技术与临床进展。

Drug-coated balloons: Technical and clinical progress.

机构信息

National Heart Centre Singapore, Singapore.

Biomedical Engineering, National University of Singapore, Singapore.

出版信息

Vasc Med. 2020 Dec;25(6):577-587. doi: 10.1177/1358863X20927791. Epub 2020 Jul 7.

Abstract

The advancement of drug-coated balloons (DCB) presents an alternative nonstent method in the percutaneous treatment of atherosclerotic lesions. While the current generation of drug-eluting stents (DES) are the device of choice, especially in coronary artery disease (CAD), DCB has potential applications in the treatment of de novo lesions, in-stent restenosis (ISR), bifurcations, and in peripheral artery disease (PAD). In terms of coronary clinical experience, DCB is used most in ISR scenarios and more data are collected to support the use of DCB in de novo lesions compared to best-in-class DES. The use of DCB in bifurcation side branch treatment has demonstrated safety, and with good angiographic and clinical outcomes, but more data from randomized trials will be required to assess its clinical value. For PAD, the clinical outcomes of DCB with and without debulking devices in diseased femoropopliteal arteries and treatment of below-the-knee (BTK) vessels with DCB are discussed. Current data demonstrated conflicting long-term safety outcomes in the use of paclitaxel devices in the femoral and/or popliteal arteries, while the role of DCB in BTK disease remains uncertain due to a lack of randomized controlled trial data. In summary, this review provides an overall view of current DCB technologies and progress, followed by an update on DCB clinical data in the treatment of CAD and PAD.

摘要

药物涂层球囊(DCB)的进步为经皮治疗动脉粥样硬化病变提供了一种非支架的替代方法。虽然目前一代药物洗脱支架(DES)是首选器械,尤其是在冠状动脉疾病(CAD)中,但 DCB 在治疗新发病变、支架内再狭窄(ISR)、分叉病变和外周动脉疾病(PAD)方面具有潜在的应用。在冠状动脉临床经验方面,DCB 主要应用于 ISR 场景,与最佳类 DES 相比,有更多的数据支持 DCB 在新发病变中的应用。在分叉病变分支治疗中,DCB 的应用已被证明是安全的,并且具有良好的血管造影和临床结果,但需要更多的随机临床试验数据来评估其临床价值。对于 PAD,讨论了在股腘动脉病变中使用具有和不具有旋切装置的 DCB 以及使用 DCB 治疗膝下(BTK)血管的临床结果。目前的数据表明,紫杉醇器械在股动脉和/或腘动脉中的应用存在长期安全性结果不一致的情况,而由于缺乏随机对照试验数据,DCB 在 BTK 疾病中的作用仍不确定。总之,本综述提供了当前 DCB 技术和进展的全面概述,随后更新了 DCB 在 CAD 和 PAD 治疗中的临床数据。

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