Abstract：
BACKGROUND: 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.
OBJECTIVE: The purpose of this study was to determine whether PCDs are associated with all-cause mortality in a real-world setting.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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).
OBJECTIVE: The purpose of this study was to determine whether PCDs are associated with all-cause mortality in a real-world setting.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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).
摘要：
背景：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（PCDs）可能与晚期死亡风险增加相关。
目的：本研究的目的是确定在现实环境中PCDs是否与全因死亡率相关。
方法：检测是全国性的，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学管理数据，代表>99%的人口。主要选择标准是第一个感兴趣的程序：2011年10月1日至2019年12月31日期间进行的涉及≥1个球囊和/或支架的下肢外周动脉疾病的血管内血运重建。在2021年12月31日之前，对有或没有PCDs的患者的全因死亡率进行比较。
结果：共分析了259,137例患者，20,083（7.7％）接受≥1PCD治疗。经过4.1年的中位数随访（Q1-Q3：2.3-6.4年），PCD组和对照组共观察到5,385例死亡/73,923人年(PY)(7.3/100PY)和109,844例死亡/1,060,513PY(10.4/100PY),分别。在对混杂因素进行调整后，在多变量Cox分析中，PCD治疗与较低的死亡风险相关(HR:0.86;95%CI:0.84-0.89;P<0.001)。使用基于最近邻或精确匹配的倾向评分匹配方法观察到类似的结果。
结论：在基于大规模现实世界数据的全国性分析中，在接受下肢外周动脉疾病血管内血运重建术的患者中,PCDs暴露与较高的死亡风险无关.（检测项目；NCT05254106）。
目的：本研究的目的是确定在现实环境中PCDs是否与全因死亡率相关。
方法：检测是全国性的，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学管理数据，代表>99%的人口。主要选择标准是第一个感兴趣的程序：2011年10月1日至2019年12月31日期间进行的涉及≥1个球囊和/或支架的下肢外周动脉疾病的血管内血运重建。在2021年12月31日之前，对有或没有PCDs的患者的全因死亡率进行比较。
结果：共分析了259,137例患者，20,083（7.7％）接受≥1PCD治疗。经过4.1年的中位数随访（Q1-Q3：2.3-6.4年），PCD组和对照组共观察到5,385例死亡/73,923人年(PY)(7.3/100PY)和109,844例死亡/1,060,513PY(10.4/100PY),分别。在对混杂因素进行调整后，在多变量Cox分析中，PCD治疗与较低的死亡风险相关(HR:0.86;95%CI:0.84-0.89;P<0.001)。使用基于最近邻或精确匹配的倾向评分匹配方法观察到类似的结果。
结论：在基于大规模现实世界数据的全国性分析中，在接受下肢外周动脉疾病血管内血运重建术的患者中,PCDs暴露与较高的死亡风险无关.（检测项目；NCT05254106）。
