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.