Article ; Online: Mortality in a Nationwide Practice-Based Cohort Receiving Paclitaxel-Coated Devices for Lower Limb Peripheral Artery Disease.
Journal of the American College of Cardiology
2024 Volume 83, Issue 13, Page(s) 1207–1221
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.: Objectives: The purpose of this study was ...
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. Objectives: 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). |
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MeSH term(s) | Humans ; Paclitaxel/therapeutic use ; Femoral Artery ; Retrospective Studies ; Peripheral Arterial Disease/surgery ; Peripheral Arterial Disease/diagnosis ; Lower Extremity ; Treatment Outcome ; Popliteal Artery/surgery ; Coated Materials, Biocompatible ; Cardiovascular Agents/therapeutic use ; Angioplasty, Balloon |
Chemical Substances | Paclitaxel (P88XT4IS4D) ; Coated Materials, Biocompatible ; Cardiovascular Agents |
Language | English |
Publishing date | 2024-03-25 |
Publishing country | United States |
Document type | Meta-Analysis ; Journal Article |
ZDB-ID | 605507-2 |
ISSN | 1558-3597 ; 0735-1097 |
ISSN (online) | 1558-3597 |
ISSN | 0735-1097 |
DOI | 10.1016/j.jacc.2024.02.003 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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