Comparison of Drug-Eluting Balloon and Standard Balloon Angioplasty for Infrapopliteal Arterial Diseases in Diabetic Patients.

OBJECTIVE: To consider the clinical outcomes and restenosis rates of drug-eluting balloons (DEBs) and percutaneous transluminal angioplasty (PTA) in diabetic patients with infrapopliteal (IP) arterial disease.

MATERIALS AND METHODS: This retrospective, single-center study included 51 patients (37 males; mean age: 63.43 ± 9.81 years) with diabetes mellitus having IP arterial disease, from October 2012 to September 2014. Twenty-two patients were treated with PTA, and 29 patients were treated with DEBs. After intervention, the patients were evaluated in the first week and every 3 months, clinically and radiologically. Univariate and multivariate analyses were used to evaluate the clinical outcomes of diabetic patients with IP arterial disease who were treated with either DEBs or PTA.

RESULTS: There were no statistically significant differences between the groups in terms of age and gender, risk factors, characteristics of lesions, or the diameters or length of the balloons ( P > .05). Primary patency was higher in the DEB group than in the PTA group (97.8% vs 81.1%, P = .020) in the first 3 months. However, there was no statistically significant difference at 1-year follow-up (68.2% vs 48.5%, P = .131). At the 12-month follow-up, there was no difference in clinical improvement between the groups ( P = .193).

CONCLUSION: The findings of this study reveal that DEB is a safe alternative treatment method for IP arterial disease in diabetic patients.