ESVS Focused Update of PAD Guidelines Addresses Safety Concerns of Paclitaxel

June 23, 2026—The European Society of Vascular Surgery (ESVS) announced the publication of a focused update on the ESVS peripheral artery disease (PAD) guidelines addressing the new findings on the safety of paclitaxel-coated devices.

In a social media post on X.com, ESVS stated that the update was conducted in light of recently published high-quality evidence, particularly the SWEDEPAD 2 trial. The findings, stated ESVS, “showed no meaningful quality-of-life benefit and raised concerns about possible long-term mortality with paclitaxel-coated devices, challenging prior assumptions about their net benefit. This prompted a focused update given the potential direct impact on patient safety and clinical decision-making in patients with 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” was published by Joakim Nordanstig, MD, et al in European Journal of Vascular and Endovascular Surgery (EJVES; 2026;71:923–927). The ESVS 2024 clinical practice guidelines were published by Dr. Nordanstig et al in January 2024 (EJVES; 2024;67:9-96).

As stated by Nordanstig et al in EJVES, “This ESVS focused update integrates emerging evidence to guide contemporary management of intermittent claudication. 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.”

They continued, “Management of intermittent claudication should follow a stepwise approach, prioritizing lifestyle modification, exercise therapy, and optimal secondary preventive pharmacotherapy, with revascularization 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.”

The findings from the SWEDEPAD 1 and 2 trials were presented last September at the ESC Congress 2025 and simultaneously published in The Lancet—SWEDEPAD 1 by Mårten Falkenburg, MD, et al (2025;406:1103-1114) and SWEDEPAD-2 by Dr. Nordanstig et al (2025;406:1115-1127).

As reported in The Lancet abstracts of the respective studies:

• The SWEDEPAD 1 investigators found, “In patients with chronic limb-threatening ischemia undergoing infrainguinal endovascular revascularization, paclitaxel-coated devices did not reduce major ipsilateral amputations.”
• The SWEDEPAD 2 investigators concluded, “In patients with Rutherford stage 1-3 peripheral artery disease undergoing infrainguinal endovascular revascularization, paclitaxel-coated devices did not improve disease-specific quality of life at 1 year compared with uncoated devices. All-cause mortality was not different over the total follow-up time, but significantly higher over 5 years. These findings do not support routine use of paclitaxel-coated devices in this patient population.”