According to a meta-analysis of randomized clinical trials, paclitaxel-coated devices (PCDs) for lower limb endovascular revascularization may be associated with increased risk of late mortality. The purpose of this study was to determine whether PCDs are associated with all-cause mortality in a real-world setting. DETECT is a nationwide, exhaustive retrospective cohort study using medico-administrative data from the French National Healthcare System representing >99% of the population. The main selection criterion was the first procedure of interest: endovascular revascularization for lower limb peripheral artery disease involving ≥1 balloon and/or stent performed between October 1, 2011, and December 31, 2019. Patients with or without PCDs were compared for all-cause mortality until December 31, 2021. A total of 259,137 patients were analyzed, with 20,083 (7.7%) treated with ≥1 PCD. After a median follow-up of 4.1 years (Q1-Q3: 2.3-6.4 years), a total of 5,385 deaths/73,923 person-years (PY) (7.3/100 PY) and 109,844 deaths/1,060,513 PY (10.4/100 PY) were observed in the PCD and control groups, respectively. After adjustment for confounding factors, PCD treatment was associated with a lower risk of mortality in multivariable Cox analyses (HR: 0.86; 95% CI: 0.84-0.89; 0.001). Similar results were observed using propensity score matching approaches based on either nearest-neighbor or exact matching. In a nationwide analysis based on large-scale real-world data, exposure to PCDs was not associated with a higher risk of mortality in patients undergoing endovascular revascularization for lower limb peripheral artery disease. (The DETECT Project; )

中文翻译：

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接受紫杉醇涂层装置治疗下肢外周动脉疾病的全国实践队列中的死亡率

根据随机临床试验的荟萃分析，用于下肢血管内血运重建的紫杉醇涂层装置（PCD）可能与晚期死亡风险增加相关。本研究的目的是确定 PCD 是否与现实世界中的全因死亡率相关。 DETECT 是一项全国性的详尽回顾性队列研究，使用来自法国国家医疗保健系统的医疗管理数据，代表超过 99% 的人口。主要选择标准是第一个感兴趣的手术：2011年10月1日至2019年12月31日期间进行的下肢外周动脉疾病血管内血运重建术，涉及≥1个球囊和/或支架。截至 2021 年 12 月 31 日，总共分析了 259,137 例患者，其中 20,083 例 (7.7%) 接受了 ≥1 PCD 治疗。中位随访时间为 4.1 年（第一季度至第三季度：2.3-6.4 年）后，共有 5,385 例死亡/73,923 人年 (PY) (7.3/100 PY) 和 109,844 例死亡/1,060,513 PY (10.4/100 PY) ）分别在 PCD 组和对照组中观察到。调整混杂因素后，多变量 Cox 分析显示 PCD 治疗与较低的死亡风险相关（HR：0.86；95% CI：0.84-0.89；0.001）。使用基于最近邻匹配或精确匹配的倾向得分匹配方法观察到类似的结果。在一项基于大规模真实世界数据的全国性分析中，对于因下肢外周动脉疾病而接受血管内血运重建的患者，接触 PCD 与较高的死亡风险无关。 （检测项目；）