Drug-Eluting vs Standard Balloon Angioplasty for Iliac Stent Restenosis: Midterm Results.

ABSTRACT

PURPOSE: To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR). METHODS: Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Follow-up examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months. RESULTS: Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434). CONCLUSION: Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR.