Editor's Choice - 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.

OBJECTIVE

This focused update to the European Society for Vascular Surgery (ESVS) clinical practice guidelines (CPGs) on asymptomatic peripheral arterial disease and intermittent claudication (IC) provide revised recommendations on paclitaxel coated devices for endovascular infrainguinal interventions. Recent evidence, particularly from the SWEDEPAD 2 trial, prompted re-evaluation of their efficacy and potential long term risks. As the previously published guidelines were directed towards patients with Rutherford categories 0 - 3, the present update maintains the same scope.

METHODS

A narrative systematic review assessed the benefits and risks of paclitaxel coated balloons and stents in infrainguinal revascularisation for IC. The ESVS Guidelines Writing Committee incorporated new randomised trial data into updated recommendations, graded according to the ESVS CPGs recommendation grading system.

RESULTS

The updated evidence suggested limited clinical benefit and possible long term harm from paclitaxel coated devices in this population. SWEDEPAD 2 reported no improvement in quality of life (difference in six item Vascular Quality of Life Questionnaire [VascuQoL-6] score at 12 months was -0.02 [95% confidence interval -0.66 - 0.62], indicating no clinically relevant effect) or in reduced re-intervention at 12 months compared with uncoated devices, and indicated a potential excess in the long term all cause mortality rate. These findings corroborate earlier safety concerns raised in a 2018 meta-analysis and in subsequent pooled analyses. Recently published long term efficacy and safety data from some additional pivotal drug coated balloon trials were also considered but reported no or marginal clinical benefits. The update consistently emphasises supervised exercise therapy and best medical therapies as first line treatment. Endovascular revascularisation is recommended only for persistent lifestyle limiting symptoms despite conservative therapy. Paclitaxel coated devices may be considered only for selected cases with re-stenosis following transparent discussion of uncertain long term safety and, at best, modest symptomatic benefit.

CONCLUSION

This ESVS focused update integrates emerging evidence to guide contemporary management of IC. Clinicians should carefully balance the limited short term procedural benefits of paclitaxel coated devices against the lack of proven quality of life improvement and the persisting uncertainty regarding long term mortality risk. Management of IC should follow a stepwise approach, prioritising lifestyle modification, exercise therapy, and optimal secondary preventive pharmacotherapy, with revascularisation reserved for compliant patients who remain significantly limited. Emphasis should be placed on conservative management, shared decision making, and continued research to further define the long term safety profile of paclitaxel coated endovascular devices.