Department of Vascular Surgery, Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK; Leicester Vascular Institute and National Institute for Health Research (NIHR) Leicester Biomedical Research Centre (BRC), Leicester, UK.
Department of Vascular Surgery, Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK.
Eur J Vasc Endovasc Surg. 2020 Aug;60(2):220-229. doi: 10.1016/j.ejvs.2020.04.008. Epub 2020 May 1.
Paclitaxel based drug coated balloons (DCBs) and drug eluting stents (DESs) may be associated with increased mortality in patients with peripheral arterial occlusive disease (PAOD), based on a recent meta-analysis. This study, however, had a number of limitations, which have been discussed at great length among the vascular community. The aim of this research was to assess the association between paclitaxel based endovascular treatment (PTX) in the femoropopliteal (F-P) segment and mortality, adjusting for relevant risk factors and including patients with chronic limb threatening ischaemia (CLTI).
This was a retrospective cohort study of a prospectively maintained multicentre (three sites) database of patients with claudication or CLTI. Patients having F-P angioplasty between 1 January 2014 and 30 May 2019 with or without PTX were included. Survival was compared in Cox regression analyses adjusted for parameters of the Charlson comorbidity index. A separate nested case matched (based on each individual's Charlson index) analysis was performed to compare mortality rates between those who received PTX and those who did not.
A total of 2 071 patients were analysed: 966 patients (46.6%) were treated with PTX (952 [46%] had CLTI and 1 119 [54%] severe claudication [Rutherford stage 3]). Over a 24 month median follow up, 456 (22.1%) patients died. Using multivariable Cox regression, PTX was not associated with mortality (HR 0.94, p = .46), even when assessed separately for those with intermittent claudication (HR 1.30, p = .15) or CLTI (HR 0.81, p = .060). In the case matched analysis (885 matched pairs of patients), PTX was not associated with mortality (HR 0.89, p = .17). Paclitaxel dose and use of a DCB or DES were not associated with mortality in any subanalysis.
When relevant risk factors were taken into account, there were no associations between PTX and mid term mortality in patients with PAOD.
最近的一项荟萃分析表明，紫杉醇药物涂层球囊（DCB）和药物洗脱支架（DES）可能与外周动脉阻塞性疾病（PAOD）患者的死亡率增加有关。然而，这项研究存在许多局限性，这在血管界引起了广泛的讨论。本研究旨在评估在股腘（F-P）段使用紫杉醇的腔内治疗（PTX）与死亡率之间的关联，同时调整相关的危险因素，并纳入患有慢性肢体威胁性缺血（CLTI）的患者。
这是一项回顾性队列研究，使用前瞻性维护的多中心（三个地点）患者数据库，这些患者患有跛行或 CLTI。纳入 2014 年 1 月 1 日至 2019 年 5 月 30 日期间接受 F-P 血管成形术治疗且有或无 PTX 的患者。使用 Cox 回归分析调整 Charlson 合并症指数的参数比较生存率。进行了单独的嵌套病例匹配（基于每个人的 Charlson 指数）分析，以比较接受和未接受 PTX 的患者的死亡率。
共分析了 2071 例患者：966 例（46.6%）接受了 PTX 治疗（952 例[46%]患有 CLTI，1119 例[54%]严重跛行[Rutherford 分期 3 级]）。在 24 个月的中位随访期间，456 例（22.1%）患者死亡。使用多变量 Cox 回归，PTX 与死亡率无关（HR 0.94，p=.46），即使分别评估间歇性跛行（HR 1.30，p=.15）或 CLTI（HR 0.81，p=.060）患者也是如此。在病例匹配分析（885 对匹配患者）中，PTX 与死亡率无关（HR 0.89，p=.17）。在任何亚组分析中，紫杉醇剂量以及 DCB 或 DES 的使用与死亡率均无关。
当考虑到相关危险因素时，PAOD 患者中 PTX 与中期死亡率之间没有关联。
