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  • Title: Efficacy of Paclitaxel Balloon for Hemodialysis Stenosis Fistulae After One Year Compared to High-Pressure Balloons: A Controlled, Multicenter, Randomized Trial.
    Author: Moreno-Sánchez T, Moreno-Ramírez M, Machancoses FH, Pardo-Moreno P, Navarro-Vergara PF, García-Revillo J.
    Journal: Cardiovasc Intervent Radiol; 2020 Mar; 43(3):382-390. PubMed ID: 31722055.
    Abstract:
    PURPOSE: A controlled, prospective, multicenter, randomized trial to compare primary patency after angioplasty with a drug-coated balloon versus plain angioplasty balloon in stenosis of dysfunctional fistulae and grafts for hemodialysis. MATERIALS AND METHODS: A total of 136 patients (148 angioplasties) at four centers were randomized to receive a drug-coated balloon or plain angioplasty balloon after satisfactory angioplasty with a high-pressure balloon. The inclusion criteria were clinical signs of vascular dysfunction confirmed by Doppler Ultrasound and/or angiography. The primary endpoint was target lesion patency defined as time elapsed between the completion of effective and the appearance of restenosis at 6 and 12 months after angioplasty. Secondary endpoints included the relationship between the location of the stenosis, previous angioplasty, demographic variables and survival. RESULTS: Primary patency after angioplasty was higher in the group treated with the drug-coated balloon than the plain angioplasty balloon (153.01 to 141.69 days at 6 months; 265.78 to 237.83 days at 12 months). Drug-coated balloon angioplasty resulted in superior patency after 6 and 12 months, but this result was not statically significant (P = 0.068 at 6 months; P = 0.369 at 12 months). There was no relation between target lesion patency and the other variables studied. Overall mortality in the plain angioplasty balloon group was higher (9% vs. 5.7%) but not statistically significant. CONCLUSIONS: Drug-coated balloon angioplasty resulted in superior survival of dysfunctional peripheral vascular access at 6 and 12 months, but this result was not statistically significant. Both arms show equivalent complications and similar mortality. LEVEL OF EVIDENCE: Level Ia, therapeutic study, RCT. EBM ratings will be based on a scale of 1-5.
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