Acotec Scientific touts 2-year data for DCB in femoropopliteal arteries

Two-year data from the AcoArt I trial of Acotec Scientific‘s drug-coated balloon in patients with femoropopliteal arterial disease were touted yesterday at the VIVA conference by Dr. Wei Guo.

The study enrolled 200 Chinese patients with peripheral artery occlusive disease and randomized them to receive the Acotec’s Orchid paclitaxel-coated balloon or a standard balloon catheter.

The trial’s primary endpoint was angiographic late lumen loss at six months, as measured by a blinded core lab. Researchers also examined clinical endpoints after 12 and 24 months.

The patient population was 74% male and had an average age of 66 years old. The researchers added that 31% of participants were smokers and 55% were diabetic. They had an average lesion length of 150 millimeters, 25% in-stent restenosis, 55% occlusion or partial occlusion and 20% had provisional stenting.

Late lumen loss after 6 months was 0.05 (+/- 0.73) millimeters in the group that received the DCB and 1.15 (+/- 0.89) in the group that received the uncoated balloon.

Also, primary patency after 24 months was 64.6% for the DCB group and 31.4% for the uncoated balloon group, the researchers reported.

After two years, the rate of freedom from clinically driven target lesion revascularization was 86.5% for those treated with the DCB and 58.6% for those treated with the uncoated balloon.

The team also reported that there were no significant differences between groups in the rates of death and major amputation.

“This demonstrates strong durability through 2 years with superior performance in primary patency for the Orchid DCB versus PTA,” the presentation said. “AcoArt I demonstrates the safety and efficacy of the Orchid DCB in treating femoropopliteal artery disease and sustained durability of the DCB treatment effect with no late catch-up through 2 years.”