A prospective, randomized study of drug-coated balloon versus plain old balloon angioplasty in management of femoropopliteal artery disease in diabetic patients: 12-month results

Abstract

Background/Purposes Despite enhanced immediate technical success, neointimal hyperplasia and restenosis remain the Achilles’ heel of endovascular interventions. Drug-coated balloons (DCBs) have shown promise in improving the outcomes of patients with peripheral arterial disease. Several trials have shown that DCB angioplasty has superior antirestenotic efficacy in the femoropopliteal artery (FPA) disease. This controlled, prospective, multicenter study was designed to establish the efficacy of DCB to improve angiographic outcomes and inhibit restenosis of the FPAs in an exclusive diabetic population in a 12-month follow-up period. Aim This controlled, prospective, multicenter study was designed to establish the efficacy of DCB to improve angiographic outcomes and inhibit restenosis of the FPAs in an exclusive diabetic population in a 12-month follow-up period. Settings and design A randomized, controlled, prospective, and multicenter study was conducted. Patients and methods Between January 2016 and December 2017, 84 consecutive adult patients with type 1 and 2 diabetes with oral euglycemics or insulin injection had been enrolled. Overall, 42 patients were treated with DCB angioplasty and 42 were treated with plain old balloon angioplasty (POBA) in a 1 : 1 randomization pattern. The primary end point of the study was the primary patency, mean diameter restenosis, and binary restenosis of the treated sites at 12 months without reintervention in the interim. Results The 12-month mean diameter restenosis was significantly lower in the DCB arm than in the POBA group (27.9±35.1 vs. 44.8±33.9%, P=0.034). Furthermore, analysis showed that the binary (≥50% diameter stenosis) restenosis rates were significantly lower in DCB patients as compared with the POBA patients (28 vs. 47%, P=0.029). The primary patency was significantly better in DCB group (71 vs. 49%, P=0.028). On the contrary, we noted that the rate of clinically driven target lesion revascularization was slightly higher in the POBA patients, though not statistically significant as compared with the paclitaxel-coated balloon group (28 vs. 20%, P=0.13). There were no procedure-related or device-related deaths in either study arm. The 12-month adverse effects, in terms of all-cause death (N3=7.1% POBA vs. N2=4.8% DCB), minor amputation (N5=12% POBA vs. N4=9.5% DCB), major amputation (0% POBA vs. N1=2.4% DCB), and myocardial infarction (N1=2.4% POBA vs. 0% DCB) were equal in both groups (P=713). Causes of mortality included myocardial infarction, cerebral infarction, and sudden death. Conclusions The treatment of diabetic peripheral arterial disease of FPA disease with IN.PACT paclitaxel-coated balloon angioplasty is associated with superior antirestenotic efficacy that provides a better primary patency rate compared with POBA at 12 months. However, DCB showed no clinical benefit over POBA at this 12-month follow-up period. The number of major adverse clinical events was comparable between DCB and POBA groups of patients.