Two-Year Outcomes of Drug-Coated Balloons versus Standard Balloons for Femoropopliteal Artery In-Stent Restenosis: Evidence from the AcoArt I Trial.

Objective: To assess the midterm efficacy and safety of drug-coated balloons (DCBs) compared with standard percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal artery in-stent restenosis in the AcoArt I Trial.

Methods: The AcoArt I Trial was a prospective, multi-centered, randomized clinical study of 50 patients with femoropopliteal artery in-stent restenosis treated with either paclitaxel-coated balloon angioplasty (DCB group; n=27) or standard PTA (PTA group; n=23). Primary patency and clinical outcomes were assessed at 6, 12, and 24 months postoperatively.

Results: Over a 24-month period, the primary patency rate of the DCB group was significantly higher than that of the PTA group (p < 0.001), with Kaplan-Meier curves demonstrating sustained superiority at all timepoints (6-month: 100% vs.55%; 12-month: 87.5% vs. 15%; 24-month: 54.2% vs. 5%). The hazard ratio for primary patency between DCB and PTA was 8.35 (95% CI: 3.72-18.74,p<0.001). Additionally, the DCB group demonstrated a significantly higher rate of freedom from clinically driven target lesion revascularization (CD-TLR) than the PTA group (88.0% vs. 31.8%; p<0.001). The incidence of major adverse events did not significantly differ between groups.

Conclusions: The use of paclitaxel-coated balloon catheters improved the angiographic and midterm clinical outcomes in most patients with in-stent restenosis.