Percutaneous angioplasty using a paclitaxel-coated balloon improves target lesion restenosis on inflow lesions of autogenous radiocephalic fistulas: a pilot study.

PURPOSE: To determine whether the use of a paclitaxel-coated balloon (PCB) improves patency in patients undergoing percutaneous transluminal angioplasty (PTA) for recurrent juxtaanastomotic stenosis of radiocephalic arteriovenous fistulas (RCAVFs).

MATERIAL AND METHODS: This prospective study recruited hemodialysis patients with two short (< 2 cm) and separated inflow RCAVF lesions. After dilation of lesions using a 4-mm plain balloon (PB), half of the lesions were randomly selected for treatment with PTA using PCB (size, 4 mm; length, 2 cm) and PB (size, 5-mm or 6-mm) (group 1), and the other half were treated with PTA using PB alone (group 2). After the index PTA, dysfunction-driven angiography was performed to confirm target lesion restenosis (TLR). TLR and lesion patency were compared in the two groups by χ(2) test, t test, and Kaplan-Meier analysis.

RESULTS: The analysis of 20 lesions in 10 patients revealed that the TLR-free duration in group 1 was significantly longer than the TLR-free duration in group 2 (251.2 d vs 103.2 d; P < .01). The patency rate of the target lesion was significantly higher in group 1 than in group 2 at 6 months (70% vs 0%; P < .01) but not at 12 months (20% vs 0%; P > .05).

CONCLUSIONS: This early study suggests that, for improving short-term patency, PTA with PCB and PB is more effective than PTA with PB alone, warranting further study.