Background: Several trials have shown that drug coated balloon (DCB) angioplasty reduce the rates of restenosis in the femoropopliteal artery. This controlled, prospective, multicenter study was designed to demonstrate the efficacy of DCB to inhibit restenosis of the infrainguinal arteries in an exclusive diabetic population.
Methods: Between 2012 and 2014, 106 diabetic patients with symptomatic peripheral arterial disease (PAD) were enrolled at 11 sites in Belgium, 54 treated with DCB angioplasty and 52 treated with plain old balloon angioplasty (POBA). The primary endpoint of the study are the primary patency, mean diameter restenosis and binary restenosis of the treated sites at 6 months without re-intervention in the interim.
Results: The 6-month mean diameter restenosis was significantly lower in the DCB arm than in the POBA group (29±36% vs. 46±35%, P=0.032) and the binary (≥50% diameter stenosis) restenosis rate was signicantly lower in DCB patients compared with the POBA's (27% vs. 49%, P=0.03). The primary patency was significantly better in the paclitaxel coated balloon group (73% vs. 51%, P=0.03). The 6-month adverse effects rates were 5.5% in the POBA and 5.7% in the DCB arm.
Conclusions: The treatment of diabetic PAD of the infra-inguinal arteries with the DCB provides a bettter primary patency rate compared with the plain old balloon angioplasty. The use of DCB did not increase the number of major adverse clinical events when compared with those seen with the use of the uncoated balloons.