Three-year DEBATE-ISR data indicate similar results for drug-eluting and plain balloon angioplasty

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Drug-eluting and plain balloon angioplasty produce similar results at three years when treating femoropopliteal in-stent restenosis, according to new data from the DEBATE-ISR trial.

Three-year results from DEBATE-ISR indicate similar target lesion revascularisation rates for drug-eluting and plain balloon angioplasty. Treatment of more complex lesions was associated with an increased rate of target lesion revascularisation, regardless of the technology used.

Writing in the Journal of Endovascular Therapy, the authors—led by Simone Grotti, San Donato Hospital, Arezzo, Italy—say that although drug-eluting balloons have shown “encouraging” immediate and one-year results when treating femoropopliteal restenosis in diabetic patients, “data on long-term clinical and angiographic outcomes in this subset of patients are limited.”

The DEBATE-ISR study enrolled 44 consecutive diabetic patients (mean age 74±11 years; 32 men) treated with drug-eluting balloons from January 2010–December 2011. The control group comprised 42 consecutive diabetic patients (age 76±7 years; 23 men) treated with conventional balloon angioplasty from 2008–2009.

No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups, and critical limb ischaemia was present in the majority of patients. Tosaka class III in-stent restenosis was observed in more than half of the patients. Mean lesion lengths were 132±86mm and 137±82mm in the drug-eluting and plan balloon groups, respectively (p=0.7).

At three-year follow-up, the authors report that the rate of target lesion revascularisation (TLR) was 40% in the drug-eluting balloon group vs 43% in the plain balloon group (p=0.8), with Kaplan-Meier analysis showing no significant differences in terms of freedom from TLR. Nine patients in each group died during follow-up, while another in each group underwent major amputation. 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 to 10.1, p=0.004). No cases of negative late lumen loss or arterial aneurysm were observed in the study population.

“Notwithstanding the suboptimal results seen in the longer period, the midterm benefit provided by drug-eluting balloons in terms of reduction of restenosis and TLR is still of value since it represents a key factor in the management of femoropopliteal in-stent restenosis,” write Grotti and colleagues. “Because continued patency favours wound healing, the antiproliferative effects of drug-eluting balloons may translate into consistent improvement in clinical outcome, particularly in patients with critical limb ischaemia.”

The authors conclude by suggesting that “Although drug-eluting balloons may be considered as the first-line treatment of in-stent restenosis, we are still far from what we believe is optimal. New drug-eluting balloon technology with higher drug bioavailability may represent a step toward this goal.”