Ziv J Haskal1, Theodore F Saad2, Jeffery G Hoggard3, Randy I Cooper4, George S Lipkowitz5, Anwar Gerges6, John R Ross7, Timothy A Pflederer8, Samuel W Mietling9. 1. Department of Radiology and Medical Imaging, University of Virginia School of Medicine, 1215 Lee Street, Charlottesville, VA 22908. Electronic address: Ziv2@mac.com. 2. Nephrology Associates Vascular Access Center, Newark, Delaware. 3. Capital Access Center, Raleigh, North Carolina. 4. SKI Vascular Center, Tempe, Arizona. 5. Baystate Medical Center, Springfield, Massachusetts. 6. Universal Vascular Center, El Paso, Texas. 7. Dialysis Access Institute, Orangeburg, South Carolina. 8. Illinois Kidney Disease and Hypertension Center, Peoria, Illinois. 9. Vascular & Interventional Care Center, Augusta, Georgia.
Abstract
PURPOSE: To present final, 2-year data from randomized comparison of an expanded polytetrafluoroethylene stent graft (SG) and percutaneous transluminal angioplasty (PTA) for treatment of arteriovenous graft (AVG) anastomotic stenoses. MATERIALS AND METHODS: A 28-site, prospective, controlled US study enrolled 270 patients with malfunctioning AVG anastomotic stenoses of ≥ 50%; 138 patients underwent SG placement, and 132 underwent PTA alone. Follow-up imaging and intervention were event-driven. RESULTS: The study was completed by 191 patients (97 SG, 94 PTA). Five patients were lost to follow-up or withdrew; 74 patients died during the study (38 SG, 36 PTA). At 12 months, treatment area primary patency (TAPP) was SG 47.6% versus PTA 24.8% (P < .001), access circuit primary patency (ACPP) was SG 24% versus PTA 11% (P = .007), and index of patency function (IPF) was SG 5.2 months/intervention ± 4.1 versus PTA 4.4 months/intervention ± 3.5 (P = .009). At 24 months, TAPP was SG 26.9% versus PTA 13.5% (P < .001), ACPP was SG 9.5% versus PTA 5.5% (P = .01), and IPF was SG 7.1 months/intervention ± 7.0 versus PTA 5.3 months/intervention ± 5.2; estimated number of reinterventions before graft abandonment was 3.4 for SG patients versus 4.3 for PTA patients. There were no significant differences in adverse events (P > .05) except for restenosis requiring reintervention rates of 82.6% in PTA patients versus 63.0% in SG patients (P < .001). CONCLUSIONS: At 2 years, SG use provided a sustained, greater than 2-fold advantage over PTA in treatment area and overall access patency. Time to subsequent intervention was longer in the SG group.
RCT Entities:
PURPOSE: To present final, 2-year data from randomized comparison of an expanded polytetrafluoroethylene stent graft (SG) and percutaneous transluminal angioplasty (PTA) for treatment of arteriovenous graft (AVG) anastomotic stenoses. MATERIALS AND METHODS: A 28-site, prospective, controlled US study enrolled 270 patients with malfunctioning AVG anastomotic stenoses of ≥ 50%; 138 patients underwent SG placement, and 132 underwent PTA alone. Follow-up imaging and intervention were event-driven. RESULTS: The study was completed by 191 patients (97 SG, 94 PTA). Five patients were lost to follow-up or withdrew; 74 patients died during the study (38 SG, 36 PTA). At 12 months, treatment area primary patency (TAPP) was SG 47.6% versus PTA 24.8% (P < .001), access circuit primary patency (ACPP) was SG 24% versus PTA 11% (P = .007), and index of patency function (IPF) was SG 5.2 months/intervention ± 4.1 versus PTA 4.4 months/intervention ± 3.5 (P = .009). At 24 months, TAPP was SG 26.9% versus PTA 13.5% (P < .001), ACPP was SG 9.5% versus PTA 5.5% (P = .01), and IPF was SG 7.1 months/intervention ± 7.0 versus PTA 5.3 months/intervention ± 5.2; estimated number of reinterventions before graft abandonment was 3.4 for SG patients versus 4.3 for PTA patients. There were no significant differences in adverse events (P > .05) except for restenosis requiring reintervention rates of 82.6% in PTA patients versus 63.0% in SG patients (P < .001). CONCLUSIONS: At 2 years, SG use provided a sustained, greater than 2-fold advantage over PTA in treatment area and overall access patency. Time to subsequent intervention was longer in the SG group.
Authors: Riccardo Corti; Pietro Quaretti; Franco Galli; Lorenzo Paolo Moramarco; Nicola Cionfoli; Giovanni Leati; Riccardo Corbetta; Matteo Tozzi Journal: SAGE Open Med Case Rep Date: 2017-11-14
Authors: Austin J Pourmoussa; Ashwin M Mahendra; Constantino S Peña; Alex Powell; Brian J Schiro; Raul Herrera; Barry T Katzen; Govindarajan Narayanan; Andrew S Niekamp; Ripal T Gandhi Journal: Semin Intervent Radiol Date: 2022-02-18 Impact factor: 1.513