الفهرس 
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Abstract
It is a prospective controlled randomized study that was performed on 80 patients presented with ischemic tissue necrosis due to infra-popliteal arterial lesions and subjected to endovascular revascularization at the Vascular and Endovascular Surgery Department, Tanta University from the beginning of December 2021 to the end of November 2023. The patients were divided into two groups. group A: had angioplasty by Drug coated balloons (number = 40) and group B: had angioplasty by standard balloons (number = 40) The aim of this study is to evaluate the safety and the efficacy of drug-coated versus plain balloon angioplasty in the treatment of infrapopliteal lesions in patients with ischemic tissue necrosis. Each patient was assessed through: full history taking, complete general and local examination, classification of patient clinical picture, laboratory investigation, duplex investigation of lower limb arteries and x-ray of the foot, as well as CT angiography, if necessary . The main outcomes were the primary patency, change of the Rutherford category at 1, 6, and 12 months, and all-cause mortality during 12-months. Secondary outcomes were procedural, technical success, TLR, reocclusion, major amputation, wound healing, major adverse limb events and change in ankle-brachial index between baseline and follow-up.. The overall mean age of patients was (60.38 ± 6.45 years), ranging between 45 years and 74 years and the median age was 60 years. The majority of the included patients in both groups were males (25 males (62.5%) in group A and 28 males (70%) in group B) with no significant difference between two groups. Regarding risk factors and comorbidities, there were no discernible difference between the two groups. Also, most characteristics were well matched between both study groups. Procedural data were likewise comparable across the two study groups. There were no procedure or device related death in either study group. The 12-month adverse effects, in term of all causes of death, minor amputation, and myocardial infarction were equal in both groups. Twelve-month follow-up for the primary endpoints were available for 33 patients (82.5%) in the DCB group and 32 patients (80%) in the standard group. On admission and throughout follow-up, there was no statistically significant difference in the mean wound size between the groups. Drug-coated balloons resulted in faster healing time (p=0.002) but no significant differences in limb salvage rates (p=0.826). Both the ABPI and PSV in this research improved after effective revascularization of either study groups. Our research showed that the primary patency rate at 12 months was much higher with drug coated balloons (75.7% vs. 59.3%). The 12-month mean diameter restenosis was significantly lower in the DCB (27.8±3.2% vs. 44.9±3.8%, p<0.001). Furthermore, analysis showed that the binary restenosis rates (≥50% diameter stenosis) was significantly lower in DCB patients (27% vs. 46%, p<0.001). On the other hand, We noted that the rate of clinically-driven TLR was significantly lower in DCB patients as compared with the Standard (6.06% vs. 18.75%, p<0.001). Freedom TLR over the time was significantly higher in DCBs group with significant difference (p<0.001).