Understudied factors in drug-coated balloon design and evaluation: A biophysical perspective.
Understudied factors in drug-coated balloon design and evaluation: A biophysical perspective.
复制标题
DOI：
10.1002/btm2.10370
复制
发表时间：
2023-01
影响因子：
7.4
通讯作者：
中科院分区：
文献类型：
--
作者：
药物涂层球囊（DCB）经皮介入治疗允许通过物理组织扩张和局部抗再狭窄药物输送持久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（如传统的金属药物洗脱支架）提供了替代方案。虽然外周动脉疾病（PAD）的DCB治疗已纳入临床指南，但由于报告显示使用紫杉醇（PTX）涂层球囊治疗的患者死亡风险增加，DCB的使用最近已减少。鉴于美国食品药品监督管理局2019年对PTX洗脱DCB的后续警告以及随后临床DCB使用的显著减少，现在迫切需要更好地了解DCB疗效和安全性的组成和机械因素。迄今为止，DCB改进的大部分工作都集中在设计启用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器械评价。我们认为，DCB性能的改善将需要更好地了解球囊展开期间和之后的生物物理因素，此外，需要详细说明和证明对这些因素的控制，以解决当前DCB使用的问题。本文提供了一个关于控制DCB性能的生物物理相互作用的观点，并为下一代DCB器械的开发提供了新的设计策略。
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.
登录
查看更多内容
影响因子：
20.1
作者：
Hwang, CW;Edelman, ER
通讯作者：
Edelman, ER
影响因子：
3.7
作者：
Colombo M;Corti A;Berceli S;Migliavacca F;McGinty S;Chiastra C
通讯作者：
Chiastra C
影响因子：
5.4
作者：
Gutierrez JA;Rao SV;Jones WS;Secemsky EA;Aday AW;Gu L;Schulteis RD;Krucoff MW;White R;Armstrong EJ;Banerjee S;Tsai S;Patel MR;Swaminathan RV
通讯作者：
Swaminathan RV
影响因子：
6.7
作者：
Cremers, Bodo;Speck, Ulrich;Scheller, Bruno
通讯作者：
Scheller, Bruno
影响因子：
37.8
作者：
Gray, William A.;Granada, Juan F.
通讯作者：
Granada, Juan F.