Drug-Coated Balloons and Stents in PAD -Limited Impact
Drug-Coated Balloons and Stents in PAD -Limited Impact
Source: Medical News, ESC Congress 2025
1- Background
• Drug-coated stents and balloons (mainly paclitaxel-based) reduce restenosis and early reinterventions in PAD.
• Their impact on key outcomes—quality of life, amputation prevention, and safety—remains uncertain.
2- SWEDEPAD 1 (CLTI, >2,300 patients)
• Compared paclitaxel-coated vs. uncoated balloons in chronic limb-threatening ischemia.
• Primary endpoint: time to above-ankle amputation.
• Findings:
• No significant difference after 5 years.
• Early reduction in reinterventions (year 1), but no sustained benefit long term.
3- SWEDEPAD 2 (Intermittent claudication, >1,100 patients)
• Compared paclitaxel-coated vs. uncoated balloons.
• Findings after follow-up:
• No difference in quality of life (12 months).
• No difference in reintervention (median 6.2 years).
• No difference in all-cause mortality (median 7.1 years).
• Higher 5-year mortality in the paclitaxel group.
4- Key Conclusion
• Paclitaxel-coated devices did not reduce amputations in CLTI or improve quality of life in claudication.
• Safety concerns remain due to possible increased long-term mortality.
• Clinicians should balance risks against the high cost before use.
• Further research is warranted into non-paclitaxel drug-coated technologies.
