Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany; Helmholtz Institute for Metabolic, Obesity and Vascular Research (HI-MAG) of the Helmholtz Zentrum München at the University of Leipzig and University Hospital Leipzig, Leipzig, Germany.
Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany.
Eur J Vasc Endovasc Surg. 2022 Nov;64(5):516-525. doi: 10.1016/j.ejvs.2022.08.004. Epub 2022 Aug 13.
Data on paclitaxel coated balloons (PCBs) for below knee (BTK) angioplasty exhibited conflicting efficacy results, and previous meta-analyses suggested an increased mortality and amputation risk highlighting the need for further research. The aim of this study was to investigate safety and efficacy of PCBs for BTK interventions in a real world cohort.
Within a single centre cohort study, 552 consecutive patients were included undergoing BTK interventions with and without PCB use. Two year safety and efficacy results were compared in unadjusted and propensity score matched (PSM) analysis.
BTK interventions were performed in 157 patients with PCB angioplasty (100% Lutonix 0.014 inch drug coated balloon; Bard Lutonix, New Hope, MN, USA) and 395 patients with plain old balloon angioplasty (POBA). The majority of interventions (> 70%) were performed for chronic limb threatening ischaemia. Mean lesion length was 20.8 ± 12.6 cm; 61.2% in the PCB and 66.7% in the POBA group were occlusions. In the PCB group, more procedures were performed for re-stenotic lesions than POBA (28.5 vs. 17.2%). In PSM analysis (128 matched pairs), the primary efficacy endpoint was freedom from clinically driven target lesion revascularisation (CD TLR), which occurred in 70.1% in the PCB and 73.1% in the POBA group at one year (p = .85; McNemar test). Survival analysis suggested lower rates of major amputations in the PCB group in unadjusted (94.4% ± 2.1 vs. 89.2% ± 1.9 in the POBA group) and PSM analyses (97.2% ± 1.6 vs. 89.3% ± 3.5) through two years, while no differences were seen for CD TLR and all cause mortality between the groups.
In this all comer analysis, PCBs were found to be safe for BTK interventions with a signal towards lower amputation rates but no benefit was seen for repeat revascularisation.
紫杉醇涂层球囊（PCBs）用于膝下（BTK）血管成形术的数据显示出相互矛盾的疗效结果，先前的荟萃分析表明死亡率和截肢风险增加，这凸显了进一步研究的必要性。本研究旨在调查真实世界队列中 BTK 介入治疗中使用 PCB 的安全性和疗效。
在单中心队列研究中，纳入了 552 例连续接受 BTK 介入治疗的患者，其中包括使用和不使用 PCB 的患者。在未调整和倾向评分匹配（PSM）分析中比较了两年的安全性和疗效结果。
157 例患者接受了 PCB 血管成形术（100% Lutonix 0.014 英寸药物涂层球囊；Bard Lutonix，New Hope，MN，USA），395 例患者接受了普通球囊血管成形术（POBA）。大多数介入治疗（>70%）是为慢性肢体威胁性缺血而进行的。平均病变长度为 20.8±12.6cm；在 PCB 组和 POBA 组中，61.2%和 66.7%分别为闭塞病变。在 PCB 组中，再狭窄病变的手术比例高于 POBA 组（28.5%比 17.2%）。在 PSM 分析（128 对匹配）中，主要疗效终点是临床驱动的靶病变血运重建（CD TLR）无失败，在 PCB 组和 POBA 组中，1 年时分别为 70.1%和 73.1%（p=0.85；McNemar 检验）。生存分析表明，在未调整分析（PCB 组为 94.4%±2.1，POBA 组为 89.2%±1.9）和 PSM 分析（PCB 组为 97.2%±1.6，POBA 组为 89.3%±3.5）中，PCB 组的主要截肢率较低，而两组之间在 CD TLR 和全因死亡率方面无差异。
在这项所有患者分析中，PCBs 用于 BTK 介入治疗是安全的，有降低截肢率的信号，但对再血运重建没有益处。
