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

ABSTRACT

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.