Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis—a multi-center study

• Published in: BMC cardiovascular disorders Vol. 23; no. 1; pp. 1 - 510
• Main Authors: Song, Xitao, Fu, Yining, Lai, Zhichao, Di, Xiao, Zeng, Rong, Shao, Jiang, Ni, Leng, Liu, Zhili, Song, Xiaojun, Ye, Wei, Liu, Changwei, Liu, Bao, Zheng, Yuehong, Chen, Yuexin
• Format: Journal Article
• Language: English
• Published: London BioMed Central Ltd 16.10.2023; BioMed Central; BMC
• Subjects: Analysis; Angioplasty; Arteriosclerosis; Atherosclerosis; Balloon; Balloon treatment; Blood pressure; Care and treatment; Clinical trials; Coatings; Disease; Drug dosages; Dysplasia; Hypertension; Informed consent; Intervention; Life expectancy; Life span; Medical imaging; Methods; Paclitaxel; Prevention; Renal artery; Renal artery obstruction; Renal function; Research design; Restenosis; Stenosis; Stents; Study Protocol; Surgery; Transluminal angioplasty; Treatment outcome; China; Beijing China
• ISSN: 1471-2261; 1471-2261
• DOI: 10.1186/s12872-023-03484-5

Abstract Introduction Renal artery stenosis (RAS) is a significant reason for secondary hypertension. Impaired renal function and subsequent cardiopulmonary dysfunction could also occur. Patients of non-atherosclerotic RAS has a relatively young age and long life expectancy. Revascularization with percutaneous transluminal angioplasty (PTA) is a viable treatment option. However, restenosis is unavoidable which limits its use. Drug-coated balloon (DCB) has been proven to be effective in restenosis prevention in femoropopliteal arterial diseases and in patients with renal artery stenosis. And PTA for Renal artery fibromuscular dysplasia is safe and clinically successful. Therefore, we could speculate that DCB might have potential efficacy in non-atherosclerotic RAS treatment. Methods and analysis This will be a randomized multi-center-controlled trial. Eighty-four eligible participants will be assigned randomly in a 1:1 ratio to the control group (plain old balloon, POB) and the experimental group (DCB). Subjects in the former group will receive balloon dilatation alone, and in the latter group will undergo the DCB angioplasty. The DCB used in this study will be a paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China). Follow-up visits will be scheduled 1, 3, 6, 9, and 12 months after the intervention. Primary outcomes will include controlled blood pressure and primary patency in the 9-month follow-up. Secondary outcomes will include technical success rate, complication rate, and bail-out stenting rate. Trial registration ClinicalTrials.gov (number NCT 05858190). Protocol version V.4 (3 May 2023).