Drug-Eluting Balloon in peripherAl inTErvention for Below the Knee Angioplasty Evaluation (DEBATE-BTK): A Randomized Trial in Diabetic Patients with Critical Limb Ischemia
Background—One-year restenosis rate after balloon angioplasty of long lesions in below-the-knee (BTK) arteries may be as high as 70%. Our aim was to investigate the efficacy of a paclitaxel drug-eluting balloon (DEB) vs. conventional percutaneous transluminal angioplasty (PTA) for the reduction of restenosis in diabetic patients with critical limb ischemia (CLI) undergoing endovascular intervention of BTK arteries.
Methods and Results—The Drug Eluting Balloon in peripherAl inTErvention (DEBATE)-BTK is a randomized, open label, single-center study comparing DEB vs. PTA. Inclusion criteria were: diabetes, critical limb ischemia (Rutherford ≥4), significant stenosis or occlusion > 40mm of at least one BTK vessel with distal run-off, and life expectancy > 1 year. Binary in-segment restenosis at 1-year angiographic or ultrasonographic follow-up was the primary endpoint. Clinically-driven target lesion revascularization (TLR), major amputation and target vessel occlusion were the secondary endpoints. One hundred and thirty two patients with 158 infrapopliteal atherosclerotic lesions were enrolled. Mean length of the treated segments was 129±83mm in the DEB vs. 131±79mm in the PTA group (p=0.7). Binary restenosis, assessed by angiography in >90% of patients, occurred in 20/74 (27%) lesions in the DEB group vs. 55/74 (74%) lesions in the PTA group (p<0.001); TLR in 12(18%) vs. 29(43%) (p=0.002); and target vessel occlusion in 12 (17%) vs. 41 (55%) (p<0.001). Only 1 major amputation occurred, in the PTA group (p=0.9).
Conclusions—DEB, as compared to PTA, strikingly reduce 1-year restenosis, target lesion revascularization, and target vessel occlusion in the treatment of BTK lesions in diabetic patients with CLI.
Clinical Trial Registration Information—http://ClinicalTrials.gov; Identifier: NCT01558505.
- Received February 6, 2013.
- Revision received May 16, 2013.
- Accepted June 12, 2013.