Nantes Université, CHU Nantes, CNRS, Inserm, l'institut du thorax, Nantes, France; Nantes Université, CHU Nantes, Pôle Hospitalo-Universitaire 11: Santé Publique, Clinique des Données, INSERM, CIC 1413, Nantes, France.
Nantes Université, CHU Nantes, Service d'information Médicale, Nantes, France.
J Am Coll Cardiol. 2024 Apr 2;83(13):1207-1221. doi: 10.1016/j.jacc.2024.02.003. Epub 2024 Mar 25.
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; P < 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; NCT05254106).
根据一项随机临床试验的荟萃分析，紫杉醇涂层装置（PCD）用于下肢血管腔内血运重建可能与晚期死亡率增加相关。
本研究旨在确定在真实环境中 PCD 是否与全因死亡率相关。
DETECT 是一项全国性的、详尽的回顾性队列研究，使用来自法国国家医疗保健系统的医疗管理数据，代表了>99%的人群。主要选择标准是首次感兴趣的程序：下肢外周动脉疾病的腔内血运重建，涉及≥1 个球囊和/或支架，于 2011 年 10 月 1 日至 2019 年 12 月 31 日期间进行。比较有或无 PCD 的患者的全因死亡率，直至 2021 年 12 月 31 日。
共分析了 259137 例患者，其中 20083 例（7.7%）接受了≥1 个 PCD 治疗。中位随访 4.1 年（Q1-Q3：2.3-6.4 年）后，PCD 组和对照组分别观察到 5385 例死亡/73923 人年（7.3/100 人年）和 109844 例死亡/1060513 人年（10.4/100 人年）。多变量 Cox 分析调整混杂因素后，PCD 治疗与死亡率降低相关（HR：0.86；95%CI：0.84-0.89；P<0.001）。基于最近邻或精确匹配的倾向评分匹配方法也得到了类似的结果。
在一项基于大规模真实世界数据的全国性分析中，在下肢外周动脉疾病的腔内血运重建中使用 PCD 与死亡率增加无关。（DETECT 项目；NCT05254106）。
