LOCAL-DELIVERY OF HEPARIN WITH BALLOON ANGIOPLASTY - RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL

PURPOSE: To evaluate the effectiveness of local delivery of heparin vi a hydrogel-coated balloons in the treatment of vascular stenoses assoc iated with hemodialysis access, MATERIALS AND METHODS: This was a rand omized, prospective trial comparing treatment with hydrogel-coated bal loon catheters delivered with heparin coating (n = 33) and without (n = 26). All patients were undergoing hemodialysis, and all stenoses inv olved the venous anastomosis of a dialysis graft or a native vein. The heparin-treated balloons were soaked in concentrated heparin and deli vered in a protected manner to help prevent washout of heparin, RESULT S: The mean primary patencies were 143 days with heparin treatment and 214 days without heparin (P = .174), The mean assisted primary patenc ies were 165 days with heparin and 194 days without (P = .315). The me an secondary patencies were 351 days with heparin and 384 without (P = .81). CONCLUSION: In this population with this technique, the treatme nt outcome of venous outflow stenosis in patients with dialysis grafts is not improved with local delivery of heparin.