Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial.

Abstract

PURPOSE\nTo assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population.\n\n\nMETHODS\nThis is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7\u2009±\u20098.8) to drug-coated balloon group (n\u2009=\u200930) or percutaneous transluminal angioplasty group (n\u2009=\u200930). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12\u2009months. The primary safety end point was freedom from perioperative death at 30\u2009days and freedom from limb-related death and major amputation at 12\u2009months.\n\n\nRESULTS\nBaseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p\u2009=\u20090.005) and lower CD-TLR rates (3.5% vs. 27.6%; p\u2009=\u20090.001) versus percutaneous transluminal angioplasty group at 12\u2009months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86\u2009±\u20090.13 vs. 0.72\u2009±\u20090.18, p\u2009=\u20090.025). There were no perioperative death at 30\u2009days, no limb-related death and no major amputation at 12\u2009months in either group.\n\n\nCONCLUSIONS\nThe randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.