Comparison of drug eluting balloon versus standard balloon results in patients with below knee peripheral artery disease

Abstract

Aim: Atherosclerotic peripheral arterial disease is frequently seen with critical leg ischemia. Despite the benefits of pharmacological agents in the lesions, the most effective treatment method is revascularization. In this study, we aimed to compare the results of drug-eluting balloon and standard balloon endovascular treatment methods. Material and Methods: One hundred and ninety-six patients who underwent infrapopliteal revascularization in Cardiovascular Surgery clinic in Namık Kemal University Hospital between January 2015 and June 2017 were included in the study. During the study, 100 patients were treated with drug-eluting balloon (DEB) (Lutonix, Bard, USA), while 96 patients were treated with standard balloon (PTA) (Nanocross, Medtronic, USA). The one-year patency rates were compared between the two groups. The patients were followed up at 1st, 3rd, 6th and 12th months after the procedure and followed by Ankle-Brachial Index (ABI) measurements and Rutherford classification. Results: Eighty three female and 113 male patients were included in the study. The mean age of the patients was 63.56±11.21. The median Rutherford classification was 4 (3-5) in the drug-eluting group according to the Rutherford classification and 4 (3-5) in the naked balloon group. During the 12-month follow-up period, limb salvage rate was 82.0% (n=82) in drug-eluting balloons and this rate was found to be 65.6% (n=63) in naked balloon group. In terms of amputation rates, the drug-eluting balloon group was found to be statistically superior (p=0.009). Conclusion: In this study, 12-month patency rates were found to be superior to naked balloons at 12-month patency rates and clinical follow-up. © 2018, Duzce University Medical School. All rights reserved.