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Subject Area

Surgery

Article Type

Original Study

Abstract

Objectives: To assess efficacy of drug eluting balloons versus standard balloons in infra-popliteal lesions in diabetic patients in the term of restenosis rate and limb salvage. Background: Using endovascular revascularization is the first strategy in all femoral–popliteal TASC A-C and infrapopliteal lesions, when revascularization is indicated. In recent years, drug-eluting balloons (DEBs) have emerged to overcome the limitations of drug-eluting stents (DESs), such as stent thrombosis. Methods: Patients were allocated to one of two groups: Group A: patients were operated by Drug eluting balloons (number = 45), Group B: patients were operated by standard balloons (number = 45). Study was undergone in Vascular unit, Department of General Surgery, Menoufia University Hospitals. Interventions were performed by antegrade approach and with the use of 6-French sheaths. In case of failure to recanalize, a retrograde approach is attempted. In DEBs group, pre-dilatation of the target lesion with standard balloons was always performed before dilatation with DEBs. Results: The primary endpoint, 12-month binary restenosis, occurred in 12 patients (26.6%) and 35 patients (77.8%) in DEBs and Standard group; respectively with high significant difference (P-value: .0001). Freedom for Target Lesion Revascularization (TLR) over the time was significantly higher in DEBs group than Standard group with significant difference. Conclusion: Drug-eluting balloons can be safely used in Infrapopliteal angioplasty, with DEBs restenosis, TLR, and target vessel occlusion were significantly lower DEBs than standard group in CLI patients.

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