PROPHYLACTIC BALLOON ANGIOPLASTY FAILS TO PROLONG THE PATENCY OF EXPANDED POLYTETRAFLUOROETHYLENE ARTERIOVENOUS GRAFTS - RESULTS OF A PROSPECTIVE RANDOMIZED STUDY

Purpose: Maintenance of hemodialysis access grafts represents an enorm ous social and clinical problem. Current grafts and graft salvage tech niques are inadequate, Consequently, there has been increasing interes t in the use of minimally invasive catheter techniques to prophylactic ally treat stenoses in functioning arteriovenous grafts, Prophylactic balloon angioplasty has been widely suggested as prolonging assisted p rimary patency, We have performed a prospective randomized trial to co mpare patients who underwent percutaneous transluminal angioplasty (PT A) for graft stenoses > 50% with a control group that received no inte rvention, Our hypothesis was that to be efficacious a minimal benefit of 20% prolongation in patency would be necessary, Methods: Color flow duplex scanning was used to detect > 50% stenoses in functioning expa nded polytetrafluoroethylene grafts. Patients were then subjected to c onfirmatory angiographic evaluation, Those wire had angiographic steno ses > 50% were randomized to balloon angioplasty or observation, Patie nts were followed-up with duplex scanning every 2 months. Statistical analysis mas performed using the Kaplan-Meier technique, Although demo graphically the patient groups were well matched, there were more prio r interventions and concurrent central stenoses in tile treatment grou p, Outcomes were graft thrombosis, graft dysfunction that precluded di alysis, and six or more PTA procedures within 18 months. Results: In t he treatment and observation groups, the 6-month patency rates were 69 % +/- 7% and 70% +/- 7%, respectively. The 12-month patency rates for the treatment and observation groups were 51% +/- 6% and 47% +/- 4%, r espectively. There was no significant difference between these two gro ups (p = 0.97), with an 80% confidence limit for detection of a differ ence greater than 20%. Conclusions: This study demonstrates that a gen eric approach of PTA to treat all polytetrafluoroethylene grafts with stenoses > 50% does not prolong patency and cannot be supported.