The European Society for Vascular Surgery (ESVS) has incorporated new data from SWEDEPAD 2 and other randomised trials into updated recommendations on the management of asymptomatic peripheral arterial disease (PAD) and intermittent claudication.
Writing in the European Journal of Vascular and Endovascular Surgery (EJVES), SWEDEPAD investigator Joakim Nordanstig (University of Gothenburg, Gothenburg, Sweden) and colleagues recommend 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”.
The authors note that ESVS focused guideline updates are issued to convey important data that emerge between the publication of full guidelines. They state that, in this case, updated evidence that has emerged since the society’s 2024 publication on asymptomatic PAD and intermittent claudication management “suggested limited clinical benefit and possible long-term harm from paclitaxel-coated devices” in this patient population.
Nordanstig and colleagues, writing on behalf of the ESVS PAD guidelines writing committee and the ESVS guidelines steering committee, specify that SWEDEPAD 2 reported no improvement in quality of life or in reduced reintervention at 12 months following use of paclitaxel devices compared with uncoated devices. Importantly, the trial also indicated a potential excess in the long-term all-cause mortality rate, which echoed safety concerns raised in a 2018 meta-analysis and subsequent pooled analyses.
Additionally, the authors note that 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,” the authors write, summarising a key takeaway from the EJVES paper. They add that endovascular revascularisation is recommended only for “persistent lifestyle-limiting symptoms despite conservative therapy”.
Furthermore, the authors advise that paclitaxel-coated devices “may be considered only for selected cases with restenosis following transparent discussion of uncertain long-term safety and, at best, modest symptomatic benefit”.
