Radiology 2021 09 6;300(3):715-724. Epub 2021 Jul 6.
From the Department of Vascular and Interventional Radiology, Division of Radiological Sciences (A.P., F.G.I., K.H.T., S.L., K.D.Z., K.D., A.G., C.W.T., S.X.J.M.C., B.S.T.), and Department of Vascular Surgery, Division of Surgery and Surgical Oncology (T.T.C., S.P.C.), Singapore General Hospital, Radiological Sciences Academic Clinical Program, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore 169608; Departments of Diagnostic Radiology (U.P., L.H.H.Q., J.K., B.P.T.) and General Surgery (G.W.L.T.), Tan Tock Seng Hospital, Singapore; Department of Biostatistics, Singapore Clinical Research Institute, Singapore (E.S.Y.C., W.Y.); Duke-NUS Medical School, National University of Singapore, Singapore (E.S.Y.C., W.Y.); and Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands (M.C.B.).
Background There is a paucity of randomized trials demonstrating superior efficacy of drug-coated balloon angioplasty (DCBA) compared with conventional percutaneous transluminal angioplasty (PTA) for below-the-knee arterial disease in patients with -critical limb ischemia. Purpose To compare DCBA versus PTA for below-the-knee lesions in participants with critical limb ischemia through 12 months. Materials and Methods In this prospective, randomized, two-center, double-blind superiority study, participants with critical limb ischemia with rest pain or tissue loss with atherosclerotic disease in the native below-the-knee arteries were randomly assigned (in a one-to-one ratio) to DCBA or PTA after stratification for diabetes and renal failure between November 2013 and October 2017. Read More