{Reference Type}: Meta-Analysis
{Title}: Mortality in a Nationwide Practice-Based Cohort Receiving Paclitaxel-Coated Devices for Lower Limb Peripheral Artery Disease.
{Author}: Wargny M;Leux C;Chatellier G;Coudol S;Gourraud PA;Gouëffic Y;
{Journal}: J Am Coll Cardiol
{Volume}: 83
{Issue}: 13
{Year}: 2024 Apr 2
{Factor}: 27.203
{DOI}: 10.1016/j.jacc.2024.02.003
{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).