Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Radiology, Institute of Clinical Sciences, Sahlgrenska University Hospital and Academy, Gothenburg, Sweden.
Prog Cardiovasc Dis. 2021 Mar-Apr;65:23-28. doi: 10.1016/j.pcad.2021.02.002. Epub 2021 Feb 13.
Lower limb peripheral artery disease is a leading cause of cardiovascular disease morbidity and mortality. Endovascular revascularization is often indicated to improve walking function and to prevent limb loss but restenosis in the treated vessel segment remains a concern that limits the overall effectiveness of the treatment. The most promising technique to prevent restenosis is the use of drug-coated devices, and the most common drug used to coat lower limb balloon angioplasty balloons and stents is paclitaxel. A systematic review and meta-analysis in 2018 reported a possible increase in late mortality attributable to paclitaxel-coated devices. Since then, their use has been brought into question. Here, we present an update of data focusing on the efficacy and safety of paclitaxel-coated devices in lower limb treatment applications. While paclitaxel-coated devices appear to reduce restenosis rates it is still unclear how these surrogate marker improvements translate to direct patient benefits and uncertainty remains as to whether paclitaxel-coated devices confer an increased risk of long-term mortality. Available randomized clinical data is hampered by trial heterogeneity, insufficient power, potential attrition bias and the lack of a plausible mechanistic explanation. An important step forward is that the ongoing trials that were temporarily halted due to the Katsanos et al. report have now both commenced recruitment and may ultimately resolve this clinical dilemma by virtue of their larger sample sizes. Other possible ways forward are the ongoing investigation of alternative anti-proliferative coating agents and use of new sophisticated vascular imaging techniques to more clearly identify patients at risk of restenosis already in the preoperative setting.
下肢外周动脉疾病是心血管疾病发病率和死亡率的主要原因。血管内血运重建通常用于改善步行功能和防止肢体丧失，但治疗血管段的再狭窄仍然是一个关注的问题，限制了治疗的整体效果。预防再狭窄最有前途的技术是使用药物涂层装置，最常用于涂覆下肢球囊血管成形术球囊和支架的药物是紫杉醇。2018 年的一项系统评价和荟萃分析报告称，紫杉醇涂层装置可能会增加晚期死亡率。从那时起，它们的使用就受到了质疑。在这里，我们更新了数据，重点介绍了紫杉醇涂层装置在下肢治疗应用中的疗效和安全性。虽然紫杉醇涂层装置似乎降低了再狭窄率，但尚不清楚这些替代标志物的改善如何转化为直接的患者受益，以及紫杉醇涂层装置是否会增加长期死亡率的风险仍存在不确定性。现有的随机临床数据受到试验异质性、效力不足、潜在的损耗偏倚以及缺乏合理的机制解释的限制。一个重要的进展是，由于 Katsanos 等人的报告而暂时停止的正在进行的试验现在都已经开始招募，并且可能最终通过其更大的样本量解决这一临床难题。其他可能的前进方向是正在研究替代抗增殖涂层剂，以及使用新的复杂的血管成像技术，以便在术前更清楚地识别有再狭窄风险的患者。
