T Moreno-Sánchez1, M Moreno-Ramírez2, F H Machancoses3, P Pardo-Moreno4, P F Navarro-Vergara5, J García-Revillo6. 1. UGC Diagnóstico por la Imagen, Radiology Department, Hospital Universitario Juan Ramón Jiménez, Ronda Norte s/n, 21005, Huelva, Spain. teresamoreno@mac.com. 2. UGC Nefrología, Hospital Universitario Juan Ramón Jiménez, Huelva, Spain. 3. Fundación Andaluza Beturia para la Investigación en Salud (FABIS), Hospital Universitario Juan Ramón Jiménez, Huelva, Spain. 4. UGC Diagnóstico por la Imagen, Hospital Universitario Virgen de las Nieves, Granada, Spain. 5. UGC Diagnóstico por la Imagen, Hospital Universitario Puerto Real, Cádiz, Spain. 6. UGC Diagnóstico por la Imagen, Hospital Universitario Reina Sofía, Córdoba, Spain.
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.
RCT Entities:
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.
Authors: Torbjörn Fransson; Anders Gottsäter; Mohammad Abdulrasak; Martin Malina; Timothy Resch Journal: J Int Med Res Date: 2022-03 Impact factor: 1.671
Authors: Chenyu Liu; Matthew Wolfers; Bint-E Zainab Awan; Issa Ali; Adrian Michael Lorenzana; Quinn Smith; George Tadros; Qian Yu Journal: J Am Heart Assoc Date: 2021-11-19 Impact factor: 6.106