The European Society for Vascular Surgery (ESVS) has incorporated new evidence, predominantly from SWEDEPAD 2, into updated recommendations on the management of asymptomatic peripheral arterial disease (PAD) and intermittent claudication.
Writing in the June issue of 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 publication has been met with some opposition. In a comment article for Vascular News, Peter Schneider (University of California, San Francisco (San Francisco, USA), Thomas Zeller (University Heart-Center Freiburg, Bad Krozingen, Germany) and colleagues take issue with the update, describing it as “such an abrupt change of course from the previous recommendations and from worldwide practice, that further consideration is warranted”.
Nordanstig and colleagues, writing in their EJVES paper 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. However, these 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”.
Speaking to Vascular News following publication of the guideline update, Nordanstig summarises the main messages from the new document. “First and foremost,” he says, “I hope that the updated guideline will reinforce the message that lower-limb revascularisation should be reserved for carefully selected patients with severely lifestyle-limiting claudication, following a comprehensive trial of non-invasive therapies, including best medical therapy and supervised exercise.”
Nordanstig goes on to highlight “considerable evidence of overtreatment of patients with claudication with invasive interventions,” which, he notes, “may not necessarily serve patients’ best interests in the longer term”.
In addition, the SWEDEPAD investigator stresses that the effectiveness of paclitaxel-coated devices “may have been overstated in the past”, and that “the most contemporary, unbiased evidence does not support their routine use in patients with claudication”.
“This is important both from the perspective of ensuring the most efficient use of healthcare resources and because the long-term safety of these devices remains uncertain,” he continues.
Indeed, the quest for evidence continues, with Nordanstig underlining “substantial knowledge gaps” that remain regarding the overall management of patients with asymptomatic PAD and intermittent claudication.
Nordanstig details that the ESVS guideline update focuses on a relatively narrow aspect of PAD management, namely the use of paclitaxel-coated devices during infrainguinal revascularisation. “Even within this specific area,” he explains, “there is, as one example, a lack of appropriately designed and conducted trials evaluating the effectiveness of drug-coated devices for the treatment of vein graft stenosis in currently asymptomatic patients with PAD who develop ultrasound-detected restenosis following femoropopliteal or femorodistal bypass surgery.”
Regarding the management of claudication, meanwhile, Nordanstig states that further trials evaluating limus-coated devices are “clearly needed”.
He points to SirPAD—published earlier this year in the New England Journal of Medicine (NEJM)—as “an important step forward” in this regard, while underlining a limitation of this trial in its inclusion of a mixed population of patients with either claudication or chronic limb-threatening ischaemia (CLTI).
On the timing of the new recommendations, Nordanstig and colleagues write in their EJVES paper that ESVS focused guideline updates are issued to convey important data that emerge between the publication of full guidelines.
Speaking to this newspaper, Nordanstig remarks: “Developing a clinical practice guideline is a substantial undertaking for the committees involved, and it is therefore understandable that comprehensive guidelines cannot be updated at frequent intervals.” Against this background, he comments that the ESVS guideline development process “is both appropriate and highly valuable”.
“In retrospect,” Nordanstig opines, “I believe that the statements regarding paclitaxel-coated devices in the 2024 ESVS clinical practice guidelines on the management of asymptomatic PAD and intermittent claudication represented as accurately and honestly as possible the evidence available to us at that time.”
He goes on to highlight “an important lesson,” however. This is that “evidence generated from pivotal trials with strict inclusion and exclusion criteria, often conducted primarily for regulatory purposes and device registration and approval, may not necessarily be directly transferable to broader, less-selected populations of patients with PAD encountered in routine clinical practice.” He describes this as “an important consideration that we should bear in mind when evaluating other novel technologies as they enter the market”.
In their comment, Schneider, Zeller and colleagues have challenged the process by which the guideline update emerged. “In order for guidelines to continue to play a prominent role in the management of vascular disease the process should be transparent, and the result should make some practical sense based upon all available data. In the recent and abrupt ESVS guideline change on claudication, much important and high-quality information is ignored, while a single study with somewhat limited applicability has assumed an outsized role to support the update,” the authors write.
Read Schneider, Zeller and colleagues’ full comment article here.
This is an extended version of an article first published on the Vascular News website in June 2026.
