Drug-Eluting Balloon in peripherAl inTErvention for Below the Knee Angioplasty Evaluation - DEBATE-BTK
The goal of the trial was to evaluate treatment with paclitaxel drug-eluting balloon angioplasty compared with conventional balloon angioplasty among diabetic patients with significant below-the-knee peripheral arterial disease.
Paclitaxel drug-eluting balloon angioplasty will reduce restenosis.
- Diabetic patients with severe below-the-knee peripheral arterial disease defined as: 1) critical limb ischemia (Rutherford ≥4), or 2) stenosis or occlusion >40 mm of at least one below-the-knee vessel with distal run-off
Number of screened applicants: 156
Number of enrollees: 132
Duration of follow-up: 12 months
Mean patient age: 74 years
Percentage female: 17%
- Life expectancy <1 year
- Allergy to paclitaxel
- Contraindication to antiplatelet therapy
- Planned major amputation
- Binary in-segment restenosis, by angiogram or ultrasound, at 1 year
- Clinically driven TLR
- Major amputation
- Target vessel occlusion
Diabetic patients with significant below-the-knee peripheral arterial disease were randomized to paclitaxel drug-eluting balloon angioplasty (n = 65) versus conventional balloon angioplasty (n = 67).
Inflation time of the study balloon was at least 2 minutes. Drug-eluting coronary stents could be used as a bail-out.
During the procedure, all patients received aspirin and unfractionated heparin. Post-procedure, patients received life-long aspirin and clopidogrel for at least 4 weeks.
Overall, 132 patients were randomized. The mean age was 74 years, 17% were women, 20% were smokers, mean ankle brachial index was 0.31, mean Rutherford class was 5.2, 78% had complete vessel occlusion, mean lesion length was 129 mm, and procedural success was achieved in 100%.
Binary restenosis occurred in 27% of the drug-eluting balloon group versus 74% of the conventional balloon angioplasty group (p < 0.001).
- Target lesion revascularization (TLR): 18% vs. 43% (p = 0.002), respectively
- Major amputation: 0 vs. 1.5% (p = 0.9), respectively
- Complete ulcer healing: 86% vs. 67% (p = 0.01), respectively
Among diabetic patients with significant below-the-knee peripheral arterial disease, the use of the paclitaxel drug-eluting balloon significantly reduced restenosis and TLR compared with conventional balloon angioplasty. A drug-eluting balloon strategy may also improve the rate of ulcer healing. Further study of this technology is warranted.
Liistro F, Porto I, Angioli P, et al. Drug-Eluting Balloon in peripherAl inTErvention for Below the Knee Angioplasty Evaluation (DEBATE-BTK): A Randomized Trial in Diabetic Patients With Critical Limb Ischemia. Circulation 2013;Jun 24:[Epub ahead of print].
Keywords: Paclitaxel, Follow-Up Studies, Ulcer, Ankle Brachial Index, Peripheral Arterial Disease, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents
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