Department of Vascular Medicine, Research Group GermanVasc, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
Healthcare Policy and Research, Weill Cornell Medical College, New York, NY, USA.
Eur J Vasc Endovasc Surg. 2020 Oct;60(4):549-558. doi: 10.1016/j.ejvs.2020.06.033. Epub 2020 Aug 14.
Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort.
A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan-Meier method and Cox regression.
There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78-0.91), amputation or death (HR 0.87, 95% CI 0.81-0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80-0.92) were observed.
In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.
腔内血管重建术已成为治疗膝下病变的标准方法，紫杉醇涂层装置已广泛应用于慢性肢体威胁性缺血患者。最近的一项荟萃分析报告称，在股腘病变中，紫杉醇涂层装置的死亡率高于未涂层装置。本研究旨在使用大型当代队列，通过常规血管护理中使用紫杉醇涂层装置的膝下干预，确定长期结果。
使用德国第二大保险基金覆盖的患者的全面健康保险索赔数据创建了一个大型队列。该队列包括 2010 年 1 月 1 日至 2018 年 12 月 31 日进行膝下动脉再血管化索引治疗的患者。仅包括首次紫杉醇涂层装置暴露的患者。该研究队列分为球囊与支架治疗，并使用倾向评分与未涂层装置匹配紫杉醇涂层装置患者。使用 Kaplan-Meier 方法和 Cox 回归评估结果。
共纳入 14738 例患者（平均年龄 77.6 岁，43.6%为女性）和 6568 例匹配患者。在研究期间，紫杉醇涂层装置的使用逐渐增加（2010 年为 6%，2018 年为 31%，p<0.001），5 年内共发生 2611 例（39.8%）死亡。在倾向评分匹配的 Cox 模型中，紫杉醇相关的五年死亡率降低（风险比，HR 0.84，95%置信区间，CI 0.78-0.91），截肢或死亡（HR 0.87，95% CI 0.81-0.94），以及心血管事件或死亡（HR 0.86，95% CI 0.80-0.92）。
在这项倾向评分匹配的队列中，与未涂层装置相比，在治疗慢性肢体威胁性缺血时，使用紫杉醇涂层装置后 5 年观察到全因死亡率降低、截肢或死亡和心血管事件或死亡发生率降低。
