In response to Peter Schneider (San Francisco, USA), Thomas Zeller (Bad Krozingen, Germany) and colleagues’ recent comment article for Vascular News on the European Society for Vascular Surgery (ESVS) claudication guideline update, Anders Wanhainen (Uppsala, Sweden), alongside co-authors Jonathan Boyle (Cambridge, UK), Maarit Venermo (Helsinki, Finland), Joakim Nordanstig (Gothenburg, Sweden), Christian-Alexander Behrendt (Neuruppin, Germany), Christopher Twine (Bristol, UK) and Isabelle van Herzeele (Ghent, Belgium), put forward their argument for the selective use of paclitaxel-coated devices.
Schneider and colleagues claim that the ESVS focused update represents an abrupt, inadequately supported change and that it ignores important randomised evidence.1,2 Neither claim is correct. The update recognises that particular paclitaxel-coated devices improve patency in selected trials. What it rejects is the unsupported assumption that better patency justifies routine drug exposure for people with intermittent claudication. The purpose of treating claudication is to make patients feel and function better. A recommendation for routine use therefore requires evidence that the added treatment improves outcomes that matter to them. This is a proportionate, responsible, and evidence-based conclusion, not a rejection of earlier research.
The earlier trials, many of them industry-sponsored, showed better patency for specific products in selected populations, frequently with scheduled imaging and protocol-driven reassessment.3–5 Those results matter. However, they do not prove that all patients treated in routine practice gain meaningful symptom relief or avoid clinically important procedures. Target-lesion revascularisation (TLR) can be influenced by surveillance intensity and the decision to intervene on an imaging finding. Schneider and colleagues give patency and TLR great weight, yet describe disease-specific quality of life as “subjective” and even potentially “experimental”. For a condition treated primarily to relieve symptoms, that hierarchy is backwards. Patient-reported benefit cannot be set aside because device-centred outcomes look favourable.
SWEDEPAD 2 was a multicentre, participant-masked randomised test of a paclitaxel-coated treatment strategy in routine care.6 It found no better disease-specific quality of life at one year, no significant reduction in target-vessel reintervention, and no significant advantage in ankle–brachial index change or Rutherford class improvement. Its pragmatic design cannot establish whether one particular device platform improves imaging-defined patency. Without imaging, it also cannot distinguish procedures at the target lesion from those elsewhere in the target vessel. These limitations do not erase its primary result. Calling a trial insufficient because it did not measure the surrogate outcome preferred by device proponents evades the question it was designed to answer.
The authors argue that including patients with milder symptoms made a benefit harder to detect. This weakens their case for routine use across a broad claudication population. If a meaningful benefit is confined to particular patients, devices or lesions, the evidence must identify them; it cannot justify exposing everyone to the drug. Nor does variation in Swedish practice invalidate randomisation. A costly device that delivers a cytotoxic drug in a non-limb-threatening condition should demonstrate worthwhile patient benefit. Advocates of routine use must show that its additional exposure, complexity and cost are justified. The burden of proof does not shift to guideline authors to demonstrate harm or absolute absence of benefit before they may advise against routine use.
The claim that the focused update ignored older trials is plainly wrong. The 2024 ESVS guideline had assessed them.7 The update reviewed new evidence in light of that earlier work. Earlier positive patency findings remain relevant, but new patient-relevant randomised evidence changes what can reasonably be concluded from them. The authors’ proposed Class I or IIa, Level A interpretation mistakes strong evidence of a patency effect for strong evidence of patient benefit. A guideline recommendation is about a clinical decision, not simply the number of trials with favourable device outcomes. It would be poor guideline practice to preserve a recommendation merely because it has become customary or commercially embedded.
The authors also overstate the update’s position on safety. SWEDEPAD 2 did not prove that paclitaxel increases mortality, and the update did not claim that it did. The overall long-term mortality comparison was not statistically significant; other analyses and observational cohorts offer some reassurance.8–10 Yet, a five-year imbalance in a randomised trial deserves investigation. A registry study showing no association, or lack of a proven biological mechanism, cannot settle the question. This uncertainty matters more when additional patient benefit from routine treatment has not been shown. Caution in that setting is sound clinical judgment, not a claim that the devices are proven dangerous.
The article’s discussion of trust and transparency makes its authors’ conflicts of interest impossible to treat as a formality. Four of the five authors disclose relationships with medical device companies.1 Schneider lists consultancy for Medtronic, Boston Scientific and Abbott among 10 companies; Zeller reports honoraria, consultancy and institutional research grants from many manufacturers, including BD Bard, Boston Scientific, Cook and Medtronic; Gouëffic reports research funding, personal fees and grants from companies including Abbott, BD, Boston Scientific, Cook and Medtronic; Steiner reports consultancy for 11 companies. Several of these companies have a direct commercial interest in drug-coated or other peripheral arterial disease (PAD) devices. These extensive relationships concern the very product at issue. They create a substantial potential financial conflict when the authors argue against a recommendation that limits routine use.
Disclosure lets readers see these interests; it does not remove their potential influence. Repeated consultancy, honoraria and sponsored research may affect which questions experts consider important, how much they trust industry-funded device trials, and how they judge a pragmatic randomised trial in routine care. That is exactly the tension exposed by this article: its authors ask readers to regard patency as compelling evidence for routine use, while casting doubt on a randomised patient-reported outcome because it did not confirm the expected benefit. Their critique therefore requires close examination, not unquestioning trust based on years of device experience. These relationships do not prove that anyone acted improperly, and they do not settle the evidence. But their critique cannot be judged separately from those interests. We disclose our own guideline, editorial, trial and industry relationships below and expect the same scrutiny.
The ESVS focused update neither discarded the earlier paclitaxel trials nor denied that some devices improve patency. It recognised that better patency does not necessarily mean better quality of life, fewer clinically important reinterventions or a clearly favourable balance of benefit and risk. SWEDEPAD 2 tested a drug-coated strategy in routine care and found no superior patient-reported outcome. Its findings do not prove harm, but they cannot be dismissed because they challenge established practice. The appropriate response is selective use, and further studies to establish which patients gain a meaningful benefit. Routine use remains a claim in need of proof.
References
- Schneider P, Zeller T, van den Berg J, et al. How should the new claudication guideline be interpreted? Vascular News. 23 September 2026.
- Nordanstig J, Hinchliffe R, Lejay A, et al. 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. Eur J Vasc Endovasc Surg. 2026;71:923–927.
- Rosenfield K, Jaff MR, White CJ, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373:145–153.
- Laird JR, Schneider PA, Tepe G, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol. 2015;66:2329–2338.
- Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133:1472–1483.
- Nordanstig J, James S, Andersson M, et al. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet. 2025;406:1115–1127.
- Nordanstig J, Behrendt C-A, Baumgartner I, et al. Editor’s choice – European Society for Vascular Surgery (ESVS) 2024 clinical practice guidelines on the management of asymptomatic lower limb peripheral arterial disease and intermittent claudication. Eur J Vasc Endovasc Surg. 2024;67:9–96.
- Parikh SA, Schneider PA, Mullin CM, et al. Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis. Lancet. 2023;402:1848–1856.
- Katsanos K, Spiliopoulos S, Saratzis A, et al. Editor’s choice – Dynamic risk of death following application of paclitaxel coated devices in the femoropopliteal artery: a contemporary meta-analysis of randomised controlled trials. Eur J Vasc Endovasc Surg. 2026;71:928–941.
- Wargny M, Leux C, Chatellier G, et al. 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.
Anders Wanhainen is professor of vascular surgery and deputy head of the Department of Surgical Science at Uppsala University (Uppsala, Sweden); Jonathan Boyle is a consultant vascular surgeon at Cambridge University Hospitals NHS Trust and affiliate assistant professor of surgery at the University of Cambridge (Cambridge, UK); Maarit Venermo is professor of vascular surgery at the University of Helsinki and head of the Department of Vascular Surgery at Helsinki University Hospital (Helsinki, Finland); Joakim Nordanstig is associate professor of vascular surgery at the University of Gothenburg (Gothenburg, Sweden); Christian-Alexander Behrendt is adjunct professor of vascular surgery at Medizinische Hochschule Brandenburg Theodor Fontane (Neuruppin, Germany); Christopher Twine is a consultant vascular surgeon at North Bristol NHS Trust and honorary professor of vascular surgery at the University of Bristol (Bristol, UK); and Isabelle van Herzeele is associate professor of thoracic and vascular surgery at Ghent University Hospital (Ghent, Belgium).
The authors have declared the following disclosures:
Anders Wanhainen: chair of the ESVS guidelines steering committee (GSC); institutional educational grants from Cook Medical and Gore
Jonathan Boyle: member of the ESVS GSC and editor-in-chief of the European Journal of Vascular and Endovascular Surgery (EJVES)
Maarit Venermo: member of the ESVS GSC and senior editor of EJVES; co-investigator in industry-funded research involving Medtronic, Medistim and Inari
Joakim Nordanstig: chair of the focused update on paclitaxel-coated technologies, from the 2024 ESVS guidelines on the management of asymptomatic peripheral arterial disease and intermittent claudication; principal investigator of SWEDEPAD; lecture honoraria from Novo Nordisk, Medtronic, BD and Abbott; academic executive and steering committee roles in trials sponsored by AstraZeneca, Eli Lilly and Regeneron; president of the Swedish Society for Vascular Surgery
Christian-Alexander Behrendt: co-chair of the focused update writing committee and section editor of EJVES
Christopher Twine: member of the ESVS GSC and section editor of EJVES
Isabelle van Herzeele: member of the ESVS GSC and section editor of EJVES; co-investigator in industry-funded research involving Abbott, Bard, Bayer, Biotronik, Boston Scientific, Cook, Novo Nordisk, Medtronic and Philips
Read more about the ESVS focused update here.
Read Peter Schneider, Thomas Zeller and colleagues’ comment piece here.
