Drug-Eluting Balloon Angioplasty for Below the Knee Lesions in End Stage Renal Disease Patients with Critical Limb Ischemia: Midterm Results.

BACKGROUND: The 1-year restenosis rate after standard balloon angioplasty (BA) of long lesions in below-the-knee arteries may be as high as 70%. Our aim was to investigate the efficacy and safety of paclitaxel drug-eluting balloon (DEB) for treatment of below the knee lesions in end stage renal disease patients (ESRD) with critical limb ischemia (CLI).

METHODS: Our study is a retrospective, single-center study. Inclusion criteria were ESRD, critical limb ischemia (Rutherford class 4 or higher) and significant stenosis or occlusion of at least 1 below-the-knee vessel. Target vessel restenosis and reocclusion at 1-year follow-up was the primary end point. Major amputation, was the secondary end point.

RESULTS: From July 2012 to February 2015, 50 patients identified with ESRD, with CLI, treated with DEB angioplasty. Six patients were lost to follow-up, leaving 44 patients with 55 vessels (mean age, 58.0 ± 6.9 years; 54.5% male). The mean lesion length was 113.4 ± 55.4 mm. BA confined to the infra-popliteal segment alone in 81.8% of cases. Primary patency was 90.4% at 6 months and 62.2% at 12 months. At a mean follow-up of 13.9 ± 3.5 months all cause mortality was 8.1% (N = 3). The ankle brachial index increased from 0.45 ± 0.04 preoperative to 0.88 ± 0.07 postoperative. There was one major amputation (2.7%) and 5 minor amputations at one year (13.5%).

CONCLUSION: DEB is effective in the treatment of below the knee critical stenosis and occlusions in ESRD patients with critical limb ischemia.