Paclitaxel-Coated Endovascular Devices for Lower Limb PAD

Mar 26, 2024
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Authors:
Wargny M, Leux C, Chattellier G, Coudol S, Gourraud PA, Gouëffic Y.
Citation:
Mortality in a Nationwide Practice-Based Cohort Receiving Paclitaxel-Coated Devices for Lower Limb Peripheral Artery Disease. J Am Coll Cardiol 2024;83:1207-1221.
Summary By:
Geoffrey D. Barnes, MD, MSc, FACC

Quick Takes

  • There has been mixed association between paclitaxel-coated devices and mortality outcomes for patients with lower extremity PAD.
  • A French nationwide analysis of >250,000 patients undergoing lower extremity revascularization found reduced mortality associated with paclitaxel-coated device use.
  • This large analysis supports the safety of paclitaxel-coated endovascular stents and balloons for lower extremity PAD revascularization.

Study Questions:

Are paclitaxel-coated devices associated with an increased all-cause mortality risk in a real-world setting?

Methods:

The authors used a nationwide, retrospective cohort study of medio-administrative data from the French National Healthcare System that includes >99% of the entire population. The authors selected patients undergoing procedures for lower extremity peripheral artery disease (PAD) revascularization using ≥1 balloon and/or stent between October 2011 and December 2019. The primary outcome of interest was all-cause mortality, compared between patients who did and did not use a paclitaxel-coated device. A multivariable Cox regression model was used to assess for the relative hazard of all-cause mortality associated with paclitaxel-coated device use. Additional statistical analyses were performed using different propensity score methods and separately for drug-coated balloons versus drug-coated stents.

Results:

The study included 259,137 patients, of whom 20,083 (7.7%) were treated with ≥1 paclitaxel-coated device. After a median follow-up of 4.1 years (interquartile range, 2.3-6.4 years), the rate of death was 7.3/100 patient-years in the paclitaxel-coated device group and 10.4/100 patient-years in the control group. After adjusting for confounding factors, paclitaxel-coated device treatment was associated with a lower risk of mortality (hazard ratio, 0.86; 95% confidence interval, 0.84-0.89). All other analyses mirrored the primary outcome findings.

Conclusions:

The authors conclude that exposure to paclitaxel-coated devices is not associated with a higher risk of mortality in patients undergoing lower extremity revascularization for PAD.

Perspective:

In late 2018, a meta-analysis of trial data suggested a potential increased risk of mortality in patients undergoing lower extremity revascularization with a paclitaxel-coated device compared to use of other devices without paclitaxel-coating. Since that time, several other studies and analyses have questioned this finding. However, these studies were limited in scope (<3,000 total patients). The authors used a French national dataset inclusive of >99% of all citizens to explore the association between paclitaxel-coated device use and all-cause mortality risk. Their finding that use of paclitaxel-coated devices is associated with a reduction in all-cause mortality for patients undergoing lower extremity arterial endovascular revascularization complements that of the SWEDEPAD trial, which found no associated increase in mortality with paclitaxel-coated device use. The large size and robust set of statistical methods used in this analysis should provide reassurance to patients, clinicians, and policymakers that paclitaxel-coated devices are safe for use in lower extremity endovascular revascularization.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and Vascular Medicine

Keywords: Drug-Eluting Stents, Peripheral Arterial Disease


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