Drug‐coated balloon treatment of complex femoropopliteal disease yields favorable and durable outcomes at 5 years

Randomized clinical trials (RCTs) of drug‐coated balloon (DCB) treatment of femoropopliteal (FP) disease compared to balloon angioplasty (PTA) have demonstrated superior outcomes. A meta‐ analysis of 13 RCTs and 9 registries demonstrated odds ratio of clinically driven target lesion revascularization (CD‐TLR) of 0.29 [95% confidence interval (CI): 0.20–0.40] at 2 years. CD‐TLR and restenosis were also significantly less frequent with paclitaxel DCBs employing urea as the excipient such as the IN.PACT Admiral DCB. Similarly, a meta‐analysis of six trials with 541 patients with FP in‐stent restenosis demonstrated a relative risk of CD‐TLR of 0.38 [95% CI: 0.27–0.54] at 1 year. The DCB groups had greater symptomatic improvement than PTA as well.