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Prospective, 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.
- Source :
-
Journal of vascular and interventional radiology : JVIR [J Vasc Interv Radiol] 2016 Aug; Vol. 27 (8), pp. 1105-1114.e3. Date of Electronic Publication: 2016 Jul 04. - Publication Year :
- 2016
-
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.<br />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.<br />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).<br />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.<br /> (Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Blood Vessel Prosthesis
Blood Vessel Prosthesis Implantation adverse effects
Blood Vessel Prosthesis Implantation instrumentation
Female
Graft Occlusion, Vascular diagnostic imaging
Graft Occlusion, Vascular etiology
Graft Occlusion, Vascular physiopathology
Humans
Male
Middle Aged
Polytetrafluoroethylene
Product Surveillance, Postmarketing
Prospective Studies
Prosthesis Design
Retreatment
Stents
Time Factors
Treatment Outcome
United States
Vascular Patency
Angioplasty, Balloon adverse effects
Arteriovenous Shunt, Surgical adverse effects
Graft Occlusion, Vascular therapy
Renal Dialysis
Subjects
Details
- Language :
- English
- ISSN :
- 1535-7732
- Volume :
- 27
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Journal of vascular and interventional radiology : JVIR
- Publication Type :
- Academic Journal
- Accession number :
- 27388566
- Full Text :
- https://doi.org/10.1016/j.jvir.2016.05.019