Dr Ziv Haskal, Professor of Radiology & Surgery, Director of Vascular & Interventional Radiology at the NewYork-Presbyterian Hospital/ Columbia University Medical Center, presented data from a multi-center randomized study, which assessed the safety and efficacy of self-expanding extended-polytetrafluoroethylene (ePTFE) encapsulated flared and straight stent-grafts compared with angioplasty (percutaneous transluminal angioplasty - PTA) for the treatment of stenotic venous anastomoses in failing synthetic arteriovenous access grafts.
The prospective, US randomized enrolled 190 patients at 16 centers, with upper extremity graft stenosis >50% and obligate hemodynamic, functional abnormalities (defined using the Dialysis Outcomes Quality Initiative (DOQI) and SIR guidelines). Functional and venographic assessments were made at two and six months with core lab analysis.
A total of 97 patients were randomized to receive stent grafts and 93 to receive PTA. Haskal reported an overall technical success rate of 99%, whilst the anatomic success (<30% stenosis) rate was 94% for stent-grafts and 73% for PTA. The researchers noted that there was no significant difference in adverse events between the two groups.
Six months binary restenosis (<50% stenosis) was reported at 26.6& for stentgrafts and 77.61% for PTA. Two month treatment primary patency for stentgrafts was 80.41%, against 77.2% for PTA, whilst six month treatment area primary patency for stent-grafts was 50.6% against 23.3.0% for PTA (p<0.001). Furthermore, six month overall access circuit primary patency rate was 38.4% for stent-grafts and 19.77% in the PTA group (p=0.008). Haskal stated that the study definitions used for loss of patency were arguably more rigorous that those found in the largely non-randomized retrospective arteriovenous access literature.
Haskal concluded that the Bard ePTFE stent-graft provides clearcut six-month patency superiority over balloon angioplasty for the treatment of stenotic venous anastomoses in arteriovenous access grafts.
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