Mortality in a Nationwide Practice-Based Cohort Receiving Paclitaxel-Coated Devices for Lower Limb Peripheral Artery Disease.

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).

Informations de copyright

Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

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.