In patients with peripheral artery disease, “improving” prognosis means relieving walking pain, increasing walking distance, preventing amputations, and achieving a better quality of life. With this objective, the SWEDEPAD program included two multicenter, randomized clinical trials: SWEDEPAD 1 enrolled patients with chronic limb-threatening ischemia (N=2355), and SWEDEPAD 2 enrolled patients with intermittent claudication (N=1136), comparing paclitaxel-coated devices versus non-coated devices. The primary endpoint was ipsilateral major amputation at 5 years.
Results showed no difference in amputations (6.2% vs 6.0%; HR 1.05; p=0.61). No differences were observed in all-cause mortality (≈10% in both groups; HR 1.01), amputation-free survival (HR 0.97; 95% CI 0.88–1.08), quality of life at 1 year (virtually no mean change: –0.02 points), or long-term reinterventions (HR 1.01; 95% CI 0.81–1.25).
However, in SWEDEPAD 2 (intermittent claudication), higher 5-year mortality was observed with coated devices: 104 vs 77 deaths (18% vs 13%; p=0.01).
The authors concluded that paclitaxel-coated devices do not reduce amputations or improve quality of life. While they decrease early reinterventions, they were associated with increased 5-year mortality in patients with intermittent claudication.
Reference: Falkenberg et al. en Major Late Breaking Trials, ESC 2025, Madrid, España.
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