Comparison of drug eluting balloon angioplasty to infrapopliteal artery critical lesions with or without additional pedal artery angioplasty in patients with diabetes mellitus and critical limb ischemia

BACKGROUND: The purpose of this study is to investigate the feasibility and outcome of balloon angioplasty for the treatment of below the ankle (BTA) lesions in addition to below the knee (BTK) lesions in diabetic patients with critical limb ischemia (CLI). METHODS: Inclusion criteria are diabetes mellitus (DM), CLI (Rutherford class 4 or higher) and revascularized significant stenosis or occlusion of at least 1 below-the-knee vessel with incomplete or no pedal loop. Target BTK vessel restenosis and reocclusion at 1-year follow-up was the primary end point whereas minor or major amputation at 1-year follow-up was the secondary end point. RESULTS: From July 2012 to June 2016, 48 diabetic patients identified with BTK with additionally BTA lesions were identified. Three patients were lost to follow-up, leaving 45 patients. In 20 patients both BTK and BTA lesion (BTA group) was revascularized whereas only BTK lesion was treated in 25 patients (BTK group). The primary end point is 15.8% in BTA group and 47.8% in BTK group (p:0.059; P > 0.05). Minor or major amputation rate at 1-year follow-up was 15.8% in BTA group and 34.8% in BTA group (p:0.190; P > 0.05). CONCLUSION: Our study shows that additional BTA angioplasty to BTK intervention may improve the primary patency rate and have higher event free rate, which slightly missed the margin of statistically significance. RBC decreased significantly more in BTA group compared to BTK group, which reflected that the outcome of intervention is better with additional BTA angioplasty.