Drug-Coated Balloon versus Plain Balloon Angioplasty for Infrapopliteal Lesions in Patients with Critical Limb Ischaemia

Background: Peripheral ischemia of the lower extremity is a condition that is prevalent worldwide and that is likely to increase with age. The increased prevalence of diabetes mellitus and hypertension in the population lead to increased proportion of peripheral arterial disease (PAD). Objective of this study is to compare effects of paclitaxel-eluting Balloon (PEB) and plain balloon (PB) angioplasty patency rate and efficacy in patients with critical infra popliteal ischemic lesions. Material and Methods: This randomized controlled trial followed, for 12 months, fifty patients with atherosclerotic disease of the infrapopliteal limb lesions, ischemic ulcer, tissue loss and rest pain. Patients were categorized into group A & B: Group (A) received paclitaxel-eluting Balloon angioplasty and group (B) received plain balloon angioplasty. An ipsilateral approach was used for stenotic lesion. This trial had been undergone at Al-Azhar University Hospitals. It lasted from May 2021 to May 2023. Results: paclitaxel-eluting Balloon group showed statistically marked decrease of restenosis compared to plain balloon at 12 months post-treatment (p-value0.05). Conclusion: Angioplasty with balloon that is coated with Paclitaxel drug decreases restenosis more than balloon that is uncoated in patients with critical infra popliteal ischemic lesions.