CardioVascular and Interventional Radiology | 2019
Efficacy of Paclitaxel Balloon for Hemodialysis Stenosis Fistulae After One Year Compared to High-Pressure Balloons: A Controlled, Multicenter, Randomized Trial
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\xa0months 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\xa0days at 6\xa0months; 265.78 to 237.83\xa0days at 12\xa0months). Drug-coated balloon angioplasty resulted in superior patency after 6 and 12\xa0months, but this result was not statically significant ( P \u2009=\u20090.068 at 6\xa0months; P \u2009=\u20090.369 at 12\xa0months). 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\xa0months, 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.