Three-Year DEBATE-ISR Data Published

January 20, 2016—Three-year results of the DEBATE-ISR study were published by Simone Grotti, MD, et al in the Journal of Endovascular Therapy (JEVT; 2016;23:52–57). The investigators report on the safety and effectiveness outcomes from the prospective all-comers DEBATE-ISR study of peripheral interventional treatment of symptomatic diabetic patients with femoropopliteal in-stent restenosis (ISR) using paclitaxel-eluting balloons compared with historical diabetic controls.

As summarized in JEVT, 44 consecutive diabetic patients (mean age, 74 ± 11 years; 32 men) were treated with drug-coated balloons (DCBs) and enrolled in the study from January 2010 to December 2011. The control group included 42 consecutive diabetic patients (age, 76 ± 7 years; 23 men) treated with conventional balloon angioplasty from 2008 to 2009. 

There were no significant differences in terms of clinical, angiographic, or procedural characteristics between the study groups. Critical limb ischemia was present in the majority of patients. Tosaka class III ISR was observed in more than half of the patients. Mean lesion length was 132 ± 86 and 137 ± 82 mm in the DCB and balloon angioplasty groups, respectively (P = .7). 

The investigators reported that at 3-year follow-up, the rate of target lesion revascularization (TLR) was 40% in the DCB group versus 43% in the balloon angioplasty group (P = .8). Kaplan-Meier analysis showed no significant differences in freedom from TLR. The presence of a Tosaka class III occlusion was associated with a worse outcome in both study groups (odds ratio, 3.96; 95% confidence interval, 1.55–10.1; P = .004). 

Using DCBs for femoropopliteal ISR yielded similar results to balloon angioplasty in terms of TLR at 3-year follow-up, and treatment of more complex ISR lesions was associated with an increased rate of TLR irrespective of the technology used, concluded the investigators in JEVT.