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J Vasc Interv Radiol · Aug 2016
Randomized Controlled Trial Multicenter Study Comparative StudyProspective, Randomized, Concurrently-Controlled Study of a Stent Graft versus Balloon Angioplasty for Treatment of Arteriovenous Access Graft Stenosis: 2-Year Results of the RENOVA Study.
- Ziv J Haskal, Theodore F Saad, Jeffery G Hoggard, Randy I Cooper, George S Lipkowitz, Anwar Gerges, John R Ross, Timothy A Pflederer, and Samuel W Mietling.
- Department of Radiology and Medical Imaging, University of Virginia School of Medicine, 1215 Lee Street, Charlottesville, VA 22908. Electronic address: Ziv2@mac.com.
- J Vasc Interv Radiol. 2016 Aug 1; 27 (8): 1105-1114.e3.
PurposeTo 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 MethodsA 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.ResultsThe 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).ConclusionsAt 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.Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.
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