Paclitaxel-coated devices in intermittent claudication: an update from the 2024 ESVS Guidelines

Selected in ESVS Journal by Thomas MONTASSIER

Paclitaxel-coated balloons and drug-eluting stents have consistently reduced restenosis and repeat revascularisation after femoropopliteal interventions.

However, concerns about a potential increase in long-term mortality, first raised by the 2018 meta-analysis by Katsanos et al., have fueled ongoing debate despite subsequent analyses.

The publication of the SWEDEPAD 2 trial in The Lancet in 2025 provided robust long-term mortality and quality-of-life data, prompting a focused update of the 2024 European Society for Vascular Surgery (ESVS) Guidelines.

References:

Authors: Joakim Nordanstig, Robert Hinchliffe, Anne Lejayd, Christian-Alexander Behrendt, on behalf of the ESVS Peripheral Arterial Disease Guidelines Writing Committee, and the ESVS Guidelines Steering Committee

Reference: Volume 71, Issue 6 p 923-927 June 2026

DOI: DOI: 10.1016/j.ejvs.2026.04.037

Read the abstract

Objective:

To provide a focused update of the ESVS Clinical Practice Guidelines on the use of paclitaxel-coated technologies for infrainguinal endovascular interventions in patients with intermittent claudication (Rutherford categories 0–3), in light of emerging evidence on their efficacy and long-term safety.

Study:

Narrative systematic review informing a focused update of the ESVS Clinical Practice Guidelines.

The ESVS Guidelines Writing Committee reviewed evidence from four randomised controlled trials published after the original guideline:

SWEDEPAD 2 (The Lancet, 2025)
ILLUMENATE European Randomized Clinical Trial
FREEWAY Trial
EffPac Trial

The new evidence was incorporated into updated recommendations using the ESVS Clinical Practice Guidelines recommendation grading system.

Population:

Patients with intermittent claudication (Rutherford categories 0–3) eligible for infrainguinal endovascular revascularisation.

Outcomes:

5-year all-cause mortality
Health-related quality of life at 12 months (VascuQoL-6)
Target lesion revascularisation
Updated ESVS recommendations on the use of paclitaxel-coated technologies in intermittent claudication

Focused Update on Paclitaxel Coated Technologies, from the 2024 European Society for Vascular Surgery (ESVS) Guidelines on the Management of Asymptomatic Peripheral Arterial Disease and Intermittent Claudication

Source: Journal Club by Thomas Montassier, based on an article published in the ESVS Journal

Discussion

Paclitaxel-coated technologies continue to offer procedural benefits by reducing restenosis and repeat revascularisation.

However, the updated evidence challenges the assumption that these advantages translate into meaningful improvements in patient-reported outcomes and raises persistent concerns regarding long-term mortality.

Although the SWEDEPAD 2 trial provides robust real-world data with extended follow-up, important questions remain regarding the biological mechanisms underlying the potential mortality signal, possible differences between drug-coated balloons and drug-eluting stents, and the role of alternative limus-based technologies.

Conclusion

The updated ESVS recommendations support a stepwise approach to the management of intermittent claudication, prioritising supervised exercise therapy, lifestyle modification and optimal medical treatment.

Endovascular revascularisation should be reserved for patients with persistent lifestyle-limiting symptoms despite conservative management.

When intervention is required, the use of paclitaxel-coated technologies should be individualised through shared decision-making, balancing their procedural benefits against the remaining uncertainty surrounding their long-term safety.