Background-The 1-year restenosis rate after balloon angioplasty of long lesions in below-the-knee arteries may be as high as 70%. Our aim was to investigate the efficacy of a paclitaxel drug-eluting balloons versus conventional percutaneous transluminal angioplasty (PTA) for the reduction of restenosis in diabetic patients with critical limb ischemia undergoing endovascular intervention of below-the-knee arteries. Methods and Results-The Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation(DEBATE-BTK) is a randomized, open-label, single-center study comparing drug-eluting balloons and PTA. Inclusion criteria were diabetes mellitus, critical limb ischemia (Rutherford class 4 or higher), significant stenosis or occlusion >40 mm of at least 1 below-the-knee vessel with distal runoff, and life expectancy >1 year. Binary in-segment restenosis at a 1-year angiographic or ultrasonographic follow-up was the primary end point. Clinically driven target lesion revascularization, major amputation, and target vessel occlusion were the secondary end points. One hundred thirty-two patients with 158 infrapopliteal atherosclerotic lesions were enrolled. Mean length of the treated segments was 129±83 mm in the drugeluting balloon group compared with 131±79 mm in the PTA group (P=0.7). Binary restenosis, assessed by angiography in >90% of patients, occurred in 20 of 74 lesions (27%) in the drug-eluting balloon group compared with 55 of 74 lesions (74%) in the PTA group (P<0.001); target lesion revascularization, in 12 (18%) versus 29 (43%; P=0.002); and target vessel occlusion, in 12 (17%) versus 41 (55%; P<0.001). Only 1 major amputation occurred, in the PTA group (P=0.9). Conclusions-Drug-eluting balloons compared with PTA strikingly reduce 1-year restenosis, target lesion revascularization, and target vessel occlusion in the treatment of below-the-knee lesions in diabetic patients with critical limb ischemia. Clinical Trial Registration-URL: http://ClinicalTrials.gov. Unique identifier: NCT01558505. Received February 6, 2013; accepted June 12, 2013. From the Cardiovascular and Neurological Department (F.L., I.P., P.A., S.G., K.D., G.F., G.V., F.T., G.B., L.B.) and Diabetes Unit (L.R.), San Donato Hospital, Arezzo, Italy; and Department of Cardiovascular Diseases, University of Siena, Le Scotte Hospital, Siena, Italy (S.G.).Correspondence to Francesco Liistro, MD, Cardiovascular and Neurological Department, San Donato Hospital, Via Pietro Nenni 20, 52100, Arezzo, Italy. E-mail francescoliistro@hotmail.com We designed a prospective, randomized trial to compare the performance of a novel DEB (IN.PACT Amphirion, Medtronic, Santa Rosa, CA) with conventional PTA in diabetics with de novo, long atherosclerotic lesions of the BTK area using 1-year binary restenosis rate as the primary end point. Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK) A Randomized Trial in Diabetic Patients With Critical Limb Ischemia Methods Study DesignThe Drug-Eluting...

Using DEB for treating femoropopliteal ISR led to a significant reduction in recurrent restenosis and repeat angioplasty at 1-year follow-up as compared to historical controls.

Using DEBs for femoropopliteal ISR yielded similar results to BA in terms of TLR at 3-year follow-up. The treatment of more complex ISR lesions was associated with an increased rate of TLR, irrespective of the technology used.

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Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542).