1. AcoArt I
Trial design: Patients with femoropopliteal artery disease were randomized to paclitaxel-coated balloon angioplasty (n = 100) vs. standard peripheral balloon angioplasty (n = 100).
Results
(p < 0.001)
Angiographic late lumen loss at 6 months: 0.05 mm in the drug-coated balloon group vs mm in the uncoated balloon group (p < 0.001)
Primary patency at 12 months: 76% with the drug-coated balloon vs. 34% with the uncoated balloon (p < 0.001)
Serious adverse events were similar between the treatment groups
1.15 mm
Conclusions
0.05
Among patients with femoropopliteal artery disease, paclitaxel-coated balloon angioplasty was superior to noncoated balloon angioplasty
Paclitaxel-coated balloon angioplasty improved late lumen loss at 6 months and primary vessel patency at 12 months
Drug-coated balloon
Uncoated balloon
Jia X, et al. JACC Cardiovasc Interv 2016;9:1950-2