Thomas Vesely1, William DaVanzo2, Terry Behrend3, Amy Dwyer4, John Aruny5. 1. Vascular Access Services, Saint Louis, Mo. Electronic address: tmvesely@gmail.com. 2. Palmyra Medical Center, St. Simons Island, Ga. 3. San Diego Vascular Access Center, San Diego, Calif. 4. Department of Medicine, University of Louisville, Louisville, Ky. 5. Department of Radiology & Biomedical Imaging, Yale University School of Medicine, New Haven, Conn.
Abstract
OBJECTIVE: To compare the results of stent graft placement to balloon angioplasty for the treatment of stenosis at the venous anastomosis of failing and thrombosed prosthetic hemodialysis grafts. METHODS: This prospective, multicenter trial included 293 patients randomized (1:1) to thestent graft (n = 145) or balloon angioplasty (n = 148) group for treatment of stenosis at the venous anastomosis of dysfunctional (n = 164) or thrombosed (n = 129) hemodialysis grafts. The primary study end point was target lesion primary patency at 6 months; participants were followed for up to 24 months. Primary patency of the access circuit was a secondary end point. Statistical analysis of effectiveness was performed using both the intent-to-treat population and the effectiveness-per-protocol (EPP) populations for primary patency end points. Statistical analysis of additional effectiveness end points was performed using the EPP population. RESULTS: The 6-month target lesion primary patency was statistically greater in the stent graft group than the balloon angioplasty group (intent-to-treat, 51.6% vs 34.2% [P = .006]; EPP, 52.9% vs 35.5% [P = .008]). Compared with the angioplasty group, the stent graft group increased the median time from the index procedure to the next intervention on the target lesion by 95 days (203 vs 108 days). Patients with dysfunctional (stenotic) grafts had higher target lesion primary patency compared with patients with thrombosed grafts regardless of treatment (EPP, stent graft, 64.6% vs 36.1% and balloon angioplasty, 45.8% vs 23.5%). When compared with angioplasty, using a stent graft for treatment of a venous anastomotic stenosis of a thrombosed graft increased the 6-month target lesion primary patency by 53.6% (EPP, 36.1% vs 23.5%). CONCLUSIONS: When compared with balloon angioplasty, a stent graft provided superior target lesion primary patency at 6 months for treatment of venous anastomotic stenoses of dysfunctional and thrombosed prosthetic hemodialysis grafts.
RCT Entities:
OBJECTIVE: To compare the results of stent graft placement to balloon angioplasty for the treatment of stenosis at the venous anastomosis of failing and thrombosed prosthetic hemodialysis grafts. METHODS: This prospective, multicenter trial included 293 patients randomized (1:1) to the stent graft (n = 145) or balloon angioplasty (n = 148) group for treatment of stenosis at the venous anastomosis of dysfunctional (n = 164) or thrombosed (n = 129) hemodialysis grafts. The primary study end point was target lesion primary patency at 6 months; participants were followed for up to 24 months. Primary patency of the access circuit was a secondary end point. Statistical analysis of effectiveness was performed using both the intent-to-treat population and the effectiveness-per-protocol (EPP) populations for primary patency end points. Statistical analysis of additional effectiveness end points was performed using the EPP population. RESULTS: The 6-month target lesion primary patency was statistically greater in the stent graft group than the balloon angioplasty group (intent-to-treat, 51.6% vs 34.2% [P = .006]; EPP, 52.9% vs 35.5% [P = .008]). Compared with the angioplasty group, the stent graft group increased the median time from the index procedure to the next intervention on the target lesion by 95 days (203 vs 108 days). Patients with dysfunctional (stenotic) grafts had higher target lesion primary patency compared with patients with thrombosed grafts regardless of treatment (EPP, stent graft, 64.6% vs 36.1% and balloon angioplasty, 45.8% vs 23.5%). When compared with angioplasty, using a stent graft for treatment of a venous anastomotic stenosis of a thrombosed graft increased the 6-month target lesion primary patency by 53.6% (EPP, 36.1% vs 23.5%). CONCLUSIONS: When compared with balloon angioplasty, a stent graft provided superior target lesion primary patency at 6 months for treatment of venous anastomotic stenoses of dysfunctional and thrombosed prosthetic hemodialysis grafts.
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: Jan Kavan; Jaroslav Kudlicka; Jan Malik; Eva Chytilova; Lukas Lambert; Marcela Slavikova; Patrik Matras; Andrea Burgetova Journal: Exp Ther Med Date: 2019-09-25 Impact factor: 2.447
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