학술논문
Mortality in a Nationwide Practice-Based Cohort Receiving Paclitaxel-Coated Devices for Lower Limb Peripheral Artery Disease.
Document Type
Academic Journal
Author
Wargny M; 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.; Leux C; Nantes Université, CHU Nantes, Service d'information Médicale, Nantes, France.; Chatellier G; Centre d'Investigations Cliniques, Unité de Recherche Clinique, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.; Coudol S; Nantes Université, CHU Nantes, Pôle Hospitalo-Universitaire 11: Santé Publique, Clinique des Données, INSERM, CIC 1413, Nantes, France.; Gourraud PA; Nantes Université, CHU Nantes, Pôle Hospitalo-Universitaire 11: Santé Publique, Clinique des Données, INSERM, CIC 1413, Nantes, France.; Gouëffic Y; Groupe Hospitalier Paris St Joseph, Department of Vascular and Endovascular Surgery, Paris, France. Electronic address: ygoueffic@ghpsj.fr.
Source
Publisher: Elsevier Biomedical Country of Publication: United States NLM ID: 8301365 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1558-3597 (Electronic) Linking ISSN: 07351097 NLM ISO Abbreviation: J Am Coll Cardiol Subsets: MEDLINE
Subject
Language
English
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).
Competing Interests: Funding Support and Author Disclosures This study was funded by Boston Scientific and Nantes University Hospital. The original statistical analyses plan was proposed by Nantes University Hospital and discussed between the 2 parts. Data access was only provided to the personnel of Nantes University Hospital, who performed all data management and analyses, and wrote the first draft of the manuscript. Results were shared with Boston Scientific prior to journal submission, with no right to object to publication’s content. Dr Wargny has received personal fees from Boston Scientific. Dr Gourraud is the founder of Methodomics (2008) and the cofounder of Big data Santé (2018); consults for major pharmaceutical companies and start-ups, all of which are handled through academic pipelines (AstraZeneca, Biogen, Boston Scientific, Cook, Docaposte, Edimark, Ellipses, Elsevier, Janssen, Lek, Methodomics, Merck, Mérieux, Octopize, and Sanofi-Genzyme); and is a volunteer board member at AXA not-for-profit mutual insurance company (2021), but has no prescription activity with either drugs or devices. Dr Gouëffic has received research funding from Boston Scientific, Cook, General Electric, Veryan, and WL Gore; and has received personal fees and grants from Abbott, Bard, Biotronik, Boston Scientific, Cook, General Electric, Medtronic, Penumbra, Terumo, Veryan, and WL Gore (medical advisory board, educational course, speaking). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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).
Competing Interests: Funding Support and Author Disclosures This study was funded by Boston Scientific and Nantes University Hospital. The original statistical analyses plan was proposed by Nantes University Hospital and discussed between the 2 parts. Data access was only provided to the personnel of Nantes University Hospital, who performed all data management and analyses, and wrote the first draft of the manuscript. Results were shared with Boston Scientific prior to journal submission, with no right to object to publication’s content. Dr Wargny has received personal fees from Boston Scientific. Dr Gourraud is the founder of Methodomics (2008) and the cofounder of Big data Santé (2018); consults for major pharmaceutical companies and start-ups, all of which are handled through academic pipelines (AstraZeneca, Biogen, Boston Scientific, Cook, Docaposte, Edimark, Ellipses, Elsevier, Janssen, Lek, Methodomics, Merck, Mérieux, Octopize, and Sanofi-Genzyme); and is a volunteer board member at AXA not-for-profit mutual insurance company (2021), but has no prescription activity with either drugs or devices. Dr Gouëffic has received research funding from Boston Scientific, Cook, General Electric, Veryan, and WL Gore; and has received personal fees and grants from Abbott, Bard, Biotronik, Boston Scientific, Cook, General Electric, Medtronic, Penumbra, Terumo, Veryan, and WL Gore (medical advisory board, educational course, speaking). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)