8:40 AM Abstract No. 75 - ■ FEATURED ABSTRACT Prospective randomized trial comparing drug-eluting balloon versus conventional percutaneous transluminal angioplasty (DEBAPTA) for the treatment of hemodialysis arteriovenous fistula or arteriovenous graft stenoses - interim report of first 30 patients

Abstract

Purpose To determine the efficacy of drug eluting balloon angioplasty (DEB) in reducing late luminal loss, improving restenosis rates, and prolonging patency rates of arteriovenous fistula and graft compared to conventional percutaneous balloon angioplasty (PTA) at 6 months. Materials and Methods From January to March 2012, 30 patients (15 males) with mean age of 59.5 years (range 33-76) were randomized to undergo either DEB after initial PTA (n=14), or PTA only (n=16) after diagnostic angiogram. Study outcomes included immediate anatomic success ( 50% stenosis) and mean late luminal loss. Results Baseline and procedural variables were comparable between groups. There was no major or minor complication, with 1 death in the DEB arm after 30 days unrelated to the procedure. Anatomic success was 92.9% (13/14) in the DEB arm and 81.3% (13/16) in the PTA arm (p=0.602). 4 patients in each treatment arm (total n=8) required intervention prior to the 6-month angiogram. At 6 months, the circuit primary patency was 43% in the DEB arm and 63% in the PTA arm (p=0.096), while targeted lesion primary patency was 50% and 68% respectively (p=0.153). The restenosis rates were 33.3% (3/9) in the DEB arm and 75.0% (9/12) in the PTA arm (p=0.087), while mean late luminal loss was 29% (SD 25.2, range 0-68) and 44% (SD 19.4, range 0-70) respectively (p=0.162). Conclusion While the restenosis rate and late luminal loss in the DEB arm are superior to PTA alone at 6 months, they did not reach statistical significance. The use of DEB did not prolong 6-month circuit or targeted lesion primary patency rates compared to PTA alone, despite improved restenosis rate and less late luminal loss.