Leading vascular specialists at CIRSE 2026 debate whether drug-coated devices should remain routine for treating leg artery disease, with emerging evidence suggesting improved vessel patency may not translate to better patient outcomes, quality of life, or survival rates.
- SWEDEPAD trials found no reduction in major amputation with paclitaxel-coated devices in patients with chronic limb-threatening ischemia, despite fewer reinterventions in the first year.
- Quality of life showed no improvement in patients with intermittent claudication using drug-coated devices, and mortality was significantly higher at five years.
- Experts recommend selective use based on lesion complexity and patient factors rather than routine application of drug-eluting devices.
- Sirolimus and everolimus alternatives show promise with smaller evidence bases, but head-to-head comparisons and longer follow-up data are still needed.
- Clinical guidelines need updating to prioritize patient-reported outcomes and limb salvage over vessel patency alone when evaluating device effectiveness.
Could SWEDEPAD, two Swedish trials comparing drug-coated and uncoated devices for leg artery treatment, change practice? CIRSE experts debated patient benefits and long-term safety.
"I do not equate better patencies with better patient outcomes," said Dr. Kristyna Johansson Spillerova of NU-sjukvården in Trollhättan, Sweden, as specialists debated drug-eluting devices for lower limb peripheral arterial disease at CIRSE 2026 in Copenhagen.
The 7 September symposium asked whether SWEDEPAD should change practice, and kept returning to the gap between what happens in the vessel and what happens to the patient.
Looking beyond patency
Johansson Spillerova put the question plainly: "What does the patient gain, actually?" Her answer was selective use of drug-coated devices, weighed case by case against lesion complexity, likely durability and what else was on the table. She flagged SWEDEPAD's five-year mortality signal in claudication patients as something that deserved attention, but cautioned that all-cause mortality on its own does not pin causation on the device.
The trial data came from Jørg Geisler of Vestfold Hospital Trust in Norway. SWEDEPAD 1, in 2,355 patients with chronic limb-threatening ischaemia, found no reduction in major amputation with paclitaxel-coated devices; the early edge in reinterventions during year one faded after that. SWEDEPAD 2, in 1,136 claudication patients, found no advantage in disease-specific quality of life at one year.
Considering alternatives
For Prof. Ulf Teichgräber of University Hospital Jena, the ranking was not in doubt: "Patient benefit has to come first." He wanted walking capacity and patient-reported outcomes counted alongside patency and repeat intervention, and offered sirolimus as an emerging alternative to paclitaxel, though on a thinner evidence base.
The head-to-head SIRONA trial hit non-inferiority for primary patency at 12 months, he reported, but superiority in what patients actually felt remained unproven, and both longer follow-up and more randomized data were still needed.
Below the knee, Dr. Michael Scheschenja urged caution. "Yes, there is evidence, but it's selective." He drew a hard line between better vessel numbers and the things that matter downstream, wound healing, limb salvage, survival. Drug-eluting stents had a case in short focal lesions, and an everolimus-eluting resorbable scaffold looked good in selected anatomy, but he warned against stretching either finding to long, distal or heavily calcified disease.
Debating routine use
Prof. Stefan Müller-Hülsbeck of DIAKO Hospital in Flensburg defended selective paclitaxel use, pointing to better patency and fewer repeat procedures, and to restenosis and complex lesions as the scenarios where it earns its place. He conceded the amputation benefit has never been shown. "Clinical practice guidelines should be updated based on comprehensive evidence and synthesis," he said.
Dr. Konstantinos Katsanos of Patras University Hospital in Greece gave no ground on the mechanism. "Does paclitaxel work? It does, unquestionably." What he would not grant was that reducing restenosis amounts to helping the patient, and with no quality-of-life gain in SWEDEPAD 2 and the mortality question still open, he argued that routine use could not be justified.
