A Prospective Multicenter Randomized Controlled Trial for Comparing Drug-Coated and Conventional Balloon Angioplasty in Venous Anastomotic Stenosis of Hemodialysis Arteriovenous Grafts

• Published in: Cardiovascular and interventional radiology Vol. 47; no. 1; pp. 36 - 44
• Main Authors: Goo, Dong Erk, Kim, Yong Jae, Park, Sang Woo, Cheon, Ho Jong, Won, You Dong, Yang, Seung Boo
• Format: Journal Article
• Language: English
• Published: New York Springer US 2024; Springer Nature B.V
• Subjects: Angioplasty; Angioplasty, Balloon - adverse effects; Arteriovenous Shunt, Surgical - adverse effects; Balloon treatment; Cardiology; Circuits; Clinical Investigation; Coatings; Constriction, Pathologic - therapy; Graft Occlusion, Vascular - diagnostic imaging; Graft Occlusion, Vascular - etiology; Graft Occlusion, Vascular - therapy; Grafting; Health services; Hemodialysis; Humans; Imaging; Lesions; Medicine; Medicine & Public Health; Nuclear Medicine; Patients; Prospective Studies; Radiology; Renal Dialysis - adverse effects; Stenosis; Time Factors; Treatment Outcome; Ultrasound; Vascular Patency; Venous Interventions; Venous anastomotic stenosis; Conventional balloon angioplasty; Arteriovenous grafts; Randomized controlled trial; Drug-coated balloon angioplasty
• ISSN: 0174-1551; 1432-086X
• DOI: 10.1007/s00270-023-03536-5

Purpose To evaluate the efficacy and safety of drug-coated balloon angioplasty compared to conventional balloon angioplasty in the treatment of dysfunctional arteriovenous grafts. Materials and Methods This prospective, multicenter, randomized clinical trial enrolled 190 patients with venous anastomotic stenosis in arteriovenous grafts at five participating hospitals. During pre-dilation, 4 patients dropped out due to ruptures requiring further treatment ( n  = 2) and residual stenosis of > 30% ( n  = 2). On successful pre-dilation with a 7 mm conventional balloon, patients were randomized to undergo either a 7 mm drug-coated balloon ( n  = 94) or conventional balloon angioplasty ( n  = 92). The primary out-come measure was target lesion primary patency at 3 and 6 months. The secondary out-come measures included target lesion primary patency at 12 months and access circuit primary patency at 6 and 12 months, clinical and technical success rates, and 12-month mortality differences between the groups. Results The target lesion primary patency and access circuit patency rates at 3 and 6 months were significantly higher in drug-coated balloon angioplasty group as compared to conventional balloon angioplasty group. The technical and clinical success rates were 100% for both the groups. As a procedure-related complication, anastomotic site rupture occurred during pre-dilation in 4 cases. The number of deaths during the 12-month follow-up was one for each group. The number of early thrombotic events (at < 3 months) was significantly higher in the drug-coated balloon group ( p  = 0.002). Conclusion Drug-coated balloon angioplasty was more effective and safer for the treatment of dysfunctional arteriovenous grafts compared to conventional balloon angioplasty.