Combined chocolate drug-coatedballoon treatment of femoropopliteal artery lesions in patients with Rutherford Grade 3-6.

Background: To investigate the efficacy of Chocolate balloon use as an adjunct to drug-coated balloon (DCB) angioplasty for the treatment of femoropopliteal lesions. Patients and methods: This retrospective study was performed with a 12-month follow-up period. The rate of flow-limiting dissection, primary patency, rate and length of bailout stenting, and freedom from major adverse limb events (MALEs) were compared between femoropopliteal lesions treated with plain balloons (PBs) and those treated with Chocolate balloons combined with DCB angioplasty. Results: In total, 192 patients (197 de-novo lesions) were included: 137 patients (141 lesions) in the PB group and 55 patients (56 lesions) in the Chocolate balloon group. The mean total lesion lengths were 126.84±71.57 and 138.39±65.35 mm (P=0.297), more than half of patients had chronic total occlusion (53.2% and 51.8%, P=0.859), the rates of flow-limiting dissection were 15.6% and 12.5% (P=0.579). Rates of primary patency were 88.1% and 92.6%, respectively. Chocolate balloon use reduced the mean total bailout stenting length (135.17±68.85 vs. 98.24±36.78 mm, P=0.022), including in complex lesions (180±70.43 vs. 102.50±44.64 mm, P=0.011), and the absolute bailout stenting length (total bailout stenting/lesion length ratio; 0.74±0.24 vs. 0.48±0.19, P=0.017). Conclusions: Relative to PB, Chocolate balloon use combined with DCB angioplasty did not show a significant advantage. It did, however, reduce the absolute total bailout stenting length in complex lesions.