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.