Drug-coated balloon (DCB) percutaneous interventional therapy allows for durable reopening of the narrowed lumen via physical tissue expansion and local anti-restenosis drug delivery, providing an alternative to traditional uncoated balloons or a permanent indwelling implant such as a conventional metallic drug-eluting stent. While DCB-based treatment of peripheral arterial disease (PAD) has been incorporated into clinical guidelines, DCB use has been recently curtailed due to reports that showed evidence of increased mortality risk in patients treated with paclitaxel (PTX)-coated balloons. Given the United States Food and Drug Administration's 2019 consequent warning regarding PTX-eluting DCBs and the subsequent marked reduction in clinical DCB use, there is now a critical need to better understand the compositional and mechanical factors underlying DCB efficacy and safety. Most work to date on DCB refinement has focused on designing both the enabling balloon catheter and alternate coatings composed of various drugs and excipients, followed by device evaluation in preclinical and clinical studies. We contend that improvement in DCB performance will require a better understanding of the biophysical factors operative during and following balloon deployment, and moreover that the elaboration and demonstrated control of these factors are needed to address current concerns with DCB use. This article provides a perspective on the biophysical interactions that govern DCB performance and offers new design strategies for the development of next-generation DCB devices.

中文翻译：

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药物涂层球囊设计和评估中待研究的因素：生物物理学的角度

药物涂层球囊（DCB）经皮介入治疗可以通过物理组织扩张和局部抗再狭窄药物输送来持久地重新打开狭窄的管腔，为传统的无涂层球囊或永久性留置植入物（例如传统的金属药物洗脱球囊）提供了替代方案支架。虽然基于 DCB 的外周动脉疾病 (PAD) 治疗已纳入临床指南，但最近 DCB 的使用已被减少，因为有报告显示，接受紫杉醇 (PTX) 涂层球囊治疗的患者死亡风险增加。鉴于美国食品和药物管理局 2019 年对 PTX 洗脱 DCB 发出警告，以及随后临床 DCB 使用量显着减少，现在迫切需要更好地了解 DCB 功效和安全性背后的成分和机械因素。迄今为止，大多数 DCB 改进工作都集中在设计可行的球囊导管和由各种药物和赋形剂组成的替代涂层，然后在临床前和临床研究中进行设备评估。我们认为，DCB 性能的改进需要更好地了解球囊展开期间和之后起作用的生物物理因素，此外，需要对这些因素进行阐述和证明控制，以解决当前对 DCB 使用的担忧。本文提供了控制 DCB 性能的生物物理相互作用的视角，并为下一代 DCB 设备的开发提供了新的设计策略。