Drug-Coated Versus Plain Balloon Angioplasty for Infrapopliteal Arterial Disease and Tissue Necrosis: A Randomized Controlled Study

Objective: To compare the safety and effectiveness of drug-coated balloon (DCB) and plain balloon angioplasty (PBA) in treating infrapopliteal (IP) atherosclerotic artery lesions in patients suffering from ischaemic tissue necrosis.Patients and Methods: The study included 80 consecutive adult patients who had infra-popliteal atherosclerotic artery lesions causing ischaemic tissue necrosis. From early December 2021 to the end of November 2023, 40 patients received PBA treatment and 40 had DCB angioplasty in a 1:1 randomisation scheme. Primary patency, Rutherford category change, mean diameter restenosis, binary restenosis, and all-cause mortality over a 12-month follow-up period were the primary outcome parameters. Procedural, technical success, major amputation, wound healing, major adverse limb events (MALE), reclusion, target lesion revascularisation (TLR), and change in ankle-brachial index between baseline and follow-up were the secondary outcomes.Results: Regarding baseline lesions characteristics and procedure data, there were no statistically significant variations between the two groups (P>.05). At the 12-month follow-up, the DCB group's main patency was much superior (75.7% vs. 59.3%, P<0.001). The DCB arm had a considerably lower 12-month mean diameter restenosis than the PBA group (27.8±3.2% vs. 44.9±3.8%, P<0.001). Compared to the PBA group, DCB patients had considerably reduced binary (≥50% diameter stenosis) restenosis rates (27% vs. 46%, P<0.001). Additionally, DCB patients had a considerably lower incidence of clinically-driven target lesion revascularisation (CD-TLR) than the PBA group (3.03% vs. 15.6%, P<0.001). Neither research group experienced any fatalities from procedures or devices.Conclusions: The treatment of Infrapopliteal arterial disease with DCB is more effective than PBA and associated with less restenosis, while the safety profile showed no significant difference between both treatment methods.