ESC 2025 – Drug-Coated Devices in PAD
ESC 2025 – Drug-Coated Devices in PAD
Source: Medscape Medical News, Sept 19, 2025 – ESC Congress, Madrid
1. Background:
• Drug-coated stents/balloons (mostly paclitaxel) tested vs. uncoated devices in PAD.
• Two RCTs: SWEDEPAD 1 (chronic limb-threatening ischemia, n=2355) and SWEDEPAD 2 (intermittent claudication, n=1155).
2. Key Results – SWEDEPAD 1:
• No difference in major amputations (primary endpoint).
• Slight reduction in reinterventions at 1 year with coated devices, but effect faded.
• No difference in mortality.
3. Key Results – SWEDEPAD 2:
• No improvement in quality of life (primary endpoint).
• No difference in reinterventions or long-term mortality.
• At 5 years: 47% higher mortality with drug-coated devices (signal of concern).
4. Controversy:
• Mortality concerns with paclitaxel devices first raised in 2018; large registries (300,000 pts) later suggested safety.