Comparison of Effectiveness of Drug-Coated Balloon Angioplasty versus Plain Balloon Angioplasty in Chronic Lower Extremity Ischemia Patients

Background Occlusive lesions of superficial femoral artery (SFA) in endovascular candidate patients are treated with balloon angioplasty with or without stenting. Recently, introduction of drug-coated balloon (DCB) angioplasty as a superior treatment option to plain balloon (PB) has been challenging. Objective The purpose of this study was to compare the effectiveness of DCB versus PB angioplasty in chronic lower extremity ischemia patients. Patients and methods In this clinical trial, 2 groups were matched at baseline; among 68 patients with peripheral artery disease, 23 patients were treated by DCB and 45 by PB. They were followed up for 6 months. Our findings of ABI, Rutherford and WIFI class changes, mortality, limb amputation, re-intervention and primary patency (PP) were collected and analyzed in comparative fashion between 2 groups. Results Mean patients age was 68.5 years (77.9% male). At 6 months, the increase in ABI in DCB was 0.37 and in PB was 0.32 (P>0.05). Mean decrease in Rutherford class in DCB and PB were 2.56, 2.28 (P>0.05). Mean decrease in WIFI class in DCB and PB were 1.48, 1.11 (P>0.05). In DCB group, 1 (4.3%) limb amputation, 3 (13%) re-interventions and no mortality with 87% PP were seen. In PB group, 2 (4.4%) limb amputation, 7 (15.6%) re-interventions, 1 (2.2%) mortality with 84.4% PP were seen. Conclusion Treatment of occlusive lesions of SFA with DCB probably may leads to improvement in ABI, Rutherford and WIFI class, higher pp and lower rate of re-interventions. Since Rutherford class and pp in DCB group have improved during 6 months compared to 1 month follow up (in our study), this improvement seems to be more significant statistically in longer term of follow up.