Long-Term Safety and Efficacy of Angioplasty of Femoropopliteal Artery Disease with Drug-Coated Balloons from the AcoArt I Trial

Abstract Objective To evaluate the long-term safety and efficacy of drug-coated balloon (DCB) treatment of Chinese patients severe femoropopliteal artery (FPA) disease (FPAD). Methods In this prospective, multi-centre, randomized controlled trial, 200 Chinese patients with FPAD were prospectively randomized to undergo percutaneous transluminal angioplasty with a DCB or uncoated balloon (UCB). The clinical endpoints were all-cause death, clinically driven target lesion revascularization, and major amputation of the treated leg 5 years after intervention. Results During the 5-year follow-up, freedom from all-cause death was 82.7% in the DCB versus 73.2% in the UCB group (log-rank p = 0.262). Freedom from clinically driven target lesion revascularization was 77.5% in the DCB versus 59.1% in the UCB group (log-rank p Conclusions We found no significant difference in 5-year mortality between patients with FPAD treated with DCBs versus UCBs. The clinical benefit of DCBs versus UCBs in terms of clinically driven target lesion revascularization persists for 5 years.