Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, UMass Medical Center, Worcester, MA.
Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, UMass Medical Center, Worcester, MA.
Ann Vasc Surg. 2024 Oct;107:76-83. doi: 10.1016/j.avsg.2023.11.061. Epub 2024 Apr 4.
For patients with Chronic Limb Threatening Ischemia (CLTI), endovascular approaches to revascularization are often employed as a component of multimodality care aimed at limb preservation. However, patients with CLTI are also prone to treatment failure, particularly following balloon angioplasty alone. Drug-coated devices utilizing Paclitaxel were developed to decrease restenosis but have been primarily studied in patients presenting with claudication. In recent years, data have emerged which describe the efficacy of drug-coated devices in the treatment of patients with CLTI. Concurrently, there has been major controversy surrounding the use of drug-coated devices in peripheral arterial disease. A historical narrative of the development and use of drug-coated devices for peripheral arterial disease is presented, along with discussion of major trials. Evidence argues that paclitaxel-based therapies for peripheral arterial disease (PAD) do not increase mortality risk compared to nondrug-coated devices. In CLTI patients, paclitaxel-based balloons and stents provide superior patency and freedom reintervention compared to nondrug-coated devices when treating femoropopliteal disease. However, the use of Paclitaxel-based therapies for below-the-knee (BTK) interventions has not been shown to provide clinically meaningful outcomes compared to nondrug-based therapies. Newer generation antiproliferative agents (Sirolimus, Everolimus) and delivery systems (bioabsorbable scaffolds) hold promise for BTK interventions with early data suggesting decreased rates of major amputation or major adverse limb events.
对于患有慢性肢体威胁性缺血（CLTI）的患者，腔内治疗方法通常作为旨在保留肢体的多模式治疗的一部分。然而，CLTI 患者也容易治疗失败，尤其是在单独进行球囊血管成形术后。使用紫杉醇的药物涂层装置旨在减少再狭窄，但主要在出现跛行的患者中进行研究。近年来，出现了描述药物涂层装置在治疗 CLTI 患者方面的疗效的数据。同时，在周围动脉疾病（PAD）中使用药物涂层装置存在主要争议。本文介绍了药物涂层装置在周围动脉疾病中的发展和使用的历史叙述，并讨论了主要的试验。有证据表明，与非药物涂层装置相比，紫杉醇类药物治疗外周动脉疾病（PAD）不会增加死亡率风险。在 CLTI 患者中，与非药物涂层装置相比，紫杉醇类球囊和支架在治疗股腘动脉疾病时提供更好的通畅率和免于再次介入的机会。然而，与非药物治疗相比，紫杉醇类药物在膝下（BTK）干预中的使用并未显示出提供有临床意义的结果。新一代抗增殖药物（西罗莫司、依维莫司）和输送系统（可生物吸收支架）为 BTK 干预带来了希望，早期数据表明，主要截肢或主要不良肢体事件的发生率降低。
