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AcoArt I: Novel DCB successfully treats femoropopliteal disease at 2 years

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Wei Guo

A novel drug-coated balloon was associated with higher rates of patency and lower rates of target lesion revascularization at 2 years vs. percutaneous transluminal angioplasty, according to data presented at VIVA 17.

For the AcoArt I study, researchers assigned 200 patients (mean age, 66 years; 74% men) with femoropopliteal artery disease to the DCB (Orchid, Acotec Scientific) or percutaneous transluminal angioplasty (PTA).

The primary endpoint was angiographic late lumen loss at 6 months. Key secondary endpoints were primary patency and clinically driven TLR at 24 months.

“The AcoArt I study is the first prospective, multicenter, randomized controlled DCB trial in Chinese patients,” Wei Guo, MD, PhD, from Chinese PLA General Hospital, Beijing, said at a press conference.

Mean lesion length was 147.26 mm in the DCB group and 151.59 mm in the PTA group. In-stent restenosis was present in 27% of the DCB group and 23% of the PTA group.

Procedural outcomes were similar between the groups, with both having 100% device success and 19% requiring provisional stenting in the DCB group vs. 21% in the PTA group (P = .48), Guo said.

Late lumen loss at 6 months was 0.05 mm in the DCB group vs. 1.15 mm in the PTA group (P < .001), Guo said. The DCB also bested PTA in minimal lumen diameter (2.38 mm vs. 1.16 mm; P < .001) and restenosis rate (22.5% vs. 70.8%; P < .001) at 6 months.

At 24 months, primary patency was 64.6% in the DCB group vs. 31.4% in the PTA group, and freedom from clinically driven TLR was 86.5% in the DCB group and 58.9% in the PTA group, according to the presentation. “There was no late catch-up” in the PTA group, Guo said.

He noted that the study had more challenging lesions than the IN.PACT SFA and LEVANT II pivotal trials of other DCBs, with longer lesion lengths, more than twice the rate of chronic total occlusions, the inclusion of patients with in-stent restenosis and a higher provisional stenting rate. Despite that, he said, 24-month patency and TLR outcomes were comparable.

In a subgroup analysis of patients who had in-stent restenosis at baseline, the researchers found that the DCB was superior to PTA in 6-month late lumen loss (–0.04 mm vs. 1.69 mm; P < .001), in 24-month primary patency (54.2% vs. 5%; P < .001) and in 24-month freedom from clinically driven TLR (87.5% vs. 25%; P < .001).

“This trial demonstrated the efficacy and safety of the Orchid DCB in treatment of femoropopliteal arteries,” Guo said.

The company intends to pursue FDA approval for the DCB, Guo said at the press conference. – by Erik Swain

Reference:

Guo WG, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 11-14, 2017; Las Vegas.

Disclosure: The study was funded by Acotec Scientific. Guo reports no relevant financial disclosures.