Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial

Purpose To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). Methods The enrollment...

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Veröffentlicht in:	Journal of endovascular therapy 2012-04, Vol.19 (2), p.263-272
Hauptverfasser:	Katsanos, Konstantinos, Karnabatidis, Dimitris, Kitrou, Panagiotis, Spiliopoulos, Stavros, Christeas, Nikolaos, Siablis, Dimitris
Format:	Artikel
Sprache:	eng
Schlagworte:	Aged Anatomy & physiology Angioplasty Angioplasty, Balloon - adverse effects Angioplasty, Balloon - instrumentation Arteriovenous Shunt, Surgical - adverse effects Blood Vessel Prosthesis Implantation - adverse effects Cardiovascular Agents - administration & dosage Catheters Cell cycle Cell division Constriction, Pathologic Drug Delivery Systems - instrumentation Drug dosages Equipment Design Family medical history Female Graft Occlusion, Vascular - diagnostic imaging Graft Occlusion, Vascular - etiology Graft Occlusion, Vascular - physiopathology Graft Occlusion, Vascular - therapy Greece Hemodialysis Humans Kaplan-Meier Estimate Kidney Failure, Chronic - therapy Male Middle Aged Mortality Paclitaxel - administration & dosage Patients Proportional Hazards Models Prospective Studies Prostheses Radiography Renal Dialysis Risk Assessment Risk Factors Stents Success Time Factors Treatment Outcome Vascular Patency Veins & arteries
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Zusammenfassung:	Purpose To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). Methods The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1±14.3 years) were randomized to undergo either PCB dilation (n=20) or standard BA (n=20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (
ISSN:	1526-6028 1545-1550
DOI:	10.1583/11-3690.1