Stent graft versus balloon angioplasty for failing dialysis-access grafts

Ziv J. Haskal, Scott Trerotola, Bart Dolmatch, Earl Schuman, Sanford Altman, Samuel Mietling, Scott Berman, Gordon McLennan, Clayton Trimmer, John Ross, Thomas Vesely

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: The leading cause of failure of a prosthetic arteriovenous hemodialysis-access graft is venous anastomotic stenosis. Balloon angioplasty, the first-line therapy, has a tendency to lead to subsequent recoil and restenosis; however, no other therapies have yet proved to be more effective. This study was designed to compare conventional balloon angioplasty with an expanded polytetrafluoroethylene endovascular stent graft for revision of venous anastomotic stenosis in failing hemodialysis grafts. METHODS: We conducted a prospective, multicenter trial, randomly assigning 190 patients who were undergoing hemodialysis and who had a venous anastomotic stenosis to undergo either balloon angioplasty alone or balloon angioplasty plus placement of the stent graft. Primary end points included patency of the treatment area and patency of the entire vascular access circuit. RESULTS: At 6 months, the incidence of patency of the treatment area was significantly greater in the stent-graft group than in the balloon-angioplasty group (51% vs. 23%, P<0.001), as was the incidence of patency of the access circuit (38% vs. 20%, P = 0.008). In addition, the incidence of freedom from subsequent interventions at 6 months was significantly greater in the stent-graft group than in the balloon-angioplasty group (32% vs. 16%, P = 0.03 by the log-rank test and P = 0.04 by the Wilcoxon rank-sum test). The incidence of binary restenosis at 6 months was greater in the balloon-angioplasty group than in the stent-graft group (78% vs. 28%, P<0.001). The incidences of adverse events at 6 months were equivalent in the two treatment groups, with the exception of restenosis, which occurred more frequently in the balloon-angioplasty group (P<0.001). Conclusions: In this study, percutaneous revision of venous anastomotic stenosis in patients with a prosthetic hemodialysis graft was improved with the use of a stent graft, which appears to provide longer-term and superior patency and freedom from repeat interventions than standard balloon angioplasty. (ClinicalTrials.gov number, NCT00678249.)

Original languageEnglish (US)
Pages (from-to)494-503
Number of pages10
JournalNew England Journal of Medicine
Volume362
Issue number6
DOIs
StatePublished - Feb 11 2010

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Balloon Angioplasty
Stents
Dialysis
Transplants
Renal Dialysis
Pathologic Constriction
Incidence
Nonparametric Statistics
Vascular Patency
Therapeutics
Polytetrafluoroethylene
Multicenter Studies

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Haskal, Z. J., Trerotola, S., Dolmatch, B., Schuman, E., Altman, S., Mietling, S., ... Vesely, T. (2010). Stent graft versus balloon angioplasty for failing dialysis-access grafts. New England Journal of Medicine, 362(6), 494-503. https://doi.org/10.1056/NEJMoa0902045

Stent graft versus balloon angioplasty for failing dialysis-access grafts. / Haskal, Ziv J.; Trerotola, Scott; Dolmatch, Bart; Schuman, Earl; Altman, Sanford; Mietling, Samuel; Berman, Scott; McLennan, Gordon; Trimmer, Clayton; Ross, John; Vesely, Thomas.

In: New England Journal of Medicine, Vol. 362, No. 6, 11.02.2010, p. 494-503.

Research output: Contribution to journalArticle

Haskal, ZJ, Trerotola, S, Dolmatch, B, Schuman, E, Altman, S, Mietling, S, Berman, S, McLennan, G, Trimmer, C, Ross, J & Vesely, T 2010, 'Stent graft versus balloon angioplasty for failing dialysis-access grafts', New England Journal of Medicine, vol. 362, no. 6, pp. 494-503. https://doi.org/10.1056/NEJMoa0902045
Haskal ZJ, Trerotola S, Dolmatch B, Schuman E, Altman S, Mietling S et al. Stent graft versus balloon angioplasty for failing dialysis-access grafts. New England Journal of Medicine. 2010 Feb 11;362(6):494-503. https://doi.org/10.1056/NEJMoa0902045
Haskal, Ziv J. ; Trerotola, Scott ; Dolmatch, Bart ; Schuman, Earl ; Altman, Sanford ; Mietling, Samuel ; Berman, Scott ; McLennan, Gordon ; Trimmer, Clayton ; Ross, John ; Vesely, Thomas. / Stent graft versus balloon angioplasty for failing dialysis-access grafts. In: New England Journal of Medicine. 2010 ; Vol. 362, No. 6. pp. 494-503.
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abstract = "BACKGROUND: The leading cause of failure of a prosthetic arteriovenous hemodialysis-access graft is venous anastomotic stenosis. Balloon angioplasty, the first-line therapy, has a tendency to lead to subsequent recoil and restenosis; however, no other therapies have yet proved to be more effective. This study was designed to compare conventional balloon angioplasty with an expanded polytetrafluoroethylene endovascular stent graft for revision of venous anastomotic stenosis in failing hemodialysis grafts. METHODS: We conducted a prospective, multicenter trial, randomly assigning 190 patients who were undergoing hemodialysis and who had a venous anastomotic stenosis to undergo either balloon angioplasty alone or balloon angioplasty plus placement of the stent graft. Primary end points included patency of the treatment area and patency of the entire vascular access circuit. RESULTS: At 6 months, the incidence of patency of the treatment area was significantly greater in the stent-graft group than in the balloon-angioplasty group (51{\%} vs. 23{\%}, P<0.001), as was the incidence of patency of the access circuit (38{\%} vs. 20{\%}, P = 0.008). In addition, the incidence of freedom from subsequent interventions at 6 months was significantly greater in the stent-graft group than in the balloon-angioplasty group (32{\%} vs. 16{\%}, P = 0.03 by the log-rank test and P = 0.04 by the Wilcoxon rank-sum test). The incidence of binary restenosis at 6 months was greater in the balloon-angioplasty group than in the stent-graft group (78{\%} vs. 28{\%}, P<0.001). The incidences of adverse events at 6 months were equivalent in the two treatment groups, with the exception of restenosis, which occurred more frequently in the balloon-angioplasty group (P<0.001). Conclusions: In this study, percutaneous revision of venous anastomotic stenosis in patients with a prosthetic hemodialysis graft was improved with the use of a stent graft, which appears to provide longer-term and superior patency and freedom from repeat interventions than standard balloon angioplasty. (ClinicalTrials.gov number, NCT00678249.)",
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AU - Trerotola, Scott

AU - Dolmatch, Bart

AU - Schuman, Earl

AU - Altman, Sanford

AU - Mietling, Samuel

AU - Berman, Scott

AU - McLennan, Gordon

AU - Trimmer, Clayton

AU - Ross, John

AU - Vesely, Thomas

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N2 - BACKGROUND: The leading cause of failure of a prosthetic arteriovenous hemodialysis-access graft is venous anastomotic stenosis. Balloon angioplasty, the first-line therapy, has a tendency to lead to subsequent recoil and restenosis; however, no other therapies have yet proved to be more effective. This study was designed to compare conventional balloon angioplasty with an expanded polytetrafluoroethylene endovascular stent graft for revision of venous anastomotic stenosis in failing hemodialysis grafts. METHODS: We conducted a prospective, multicenter trial, randomly assigning 190 patients who were undergoing hemodialysis and who had a venous anastomotic stenosis to undergo either balloon angioplasty alone or balloon angioplasty plus placement of the stent graft. Primary end points included patency of the treatment area and patency of the entire vascular access circuit. RESULTS: At 6 months, the incidence of patency of the treatment area was significantly greater in the stent-graft group than in the balloon-angioplasty group (51% vs. 23%, P<0.001), as was the incidence of patency of the access circuit (38% vs. 20%, P = 0.008). In addition, the incidence of freedom from subsequent interventions at 6 months was significantly greater in the stent-graft group than in the balloon-angioplasty group (32% vs. 16%, P = 0.03 by the log-rank test and P = 0.04 by the Wilcoxon rank-sum test). The incidence of binary restenosis at 6 months was greater in the balloon-angioplasty group than in the stent-graft group (78% vs. 28%, P<0.001). The incidences of adverse events at 6 months were equivalent in the two treatment groups, with the exception of restenosis, which occurred more frequently in the balloon-angioplasty group (P<0.001). Conclusions: In this study, percutaneous revision of venous anastomotic stenosis in patients with a prosthetic hemodialysis graft was improved with the use of a stent graft, which appears to provide longer-term and superior patency and freedom from repeat interventions than standard balloon angioplasty. (ClinicalTrials.gov number, NCT00678249.)

AB - BACKGROUND: The leading cause of failure of a prosthetic arteriovenous hemodialysis-access graft is venous anastomotic stenosis. Balloon angioplasty, the first-line therapy, has a tendency to lead to subsequent recoil and restenosis; however, no other therapies have yet proved to be more effective. This study was designed to compare conventional balloon angioplasty with an expanded polytetrafluoroethylene endovascular stent graft for revision of venous anastomotic stenosis in failing hemodialysis grafts. METHODS: We conducted a prospective, multicenter trial, randomly assigning 190 patients who were undergoing hemodialysis and who had a venous anastomotic stenosis to undergo either balloon angioplasty alone or balloon angioplasty plus placement of the stent graft. Primary end points included patency of the treatment area and patency of the entire vascular access circuit. RESULTS: At 6 months, the incidence of patency of the treatment area was significantly greater in the stent-graft group than in the balloon-angioplasty group (51% vs. 23%, P<0.001), as was the incidence of patency of the access circuit (38% vs. 20%, P = 0.008). In addition, the incidence of freedom from subsequent interventions at 6 months was significantly greater in the stent-graft group than in the balloon-angioplasty group (32% vs. 16%, P = 0.03 by the log-rank test and P = 0.04 by the Wilcoxon rank-sum test). The incidence of binary restenosis at 6 months was greater in the balloon-angioplasty group than in the stent-graft group (78% vs. 28%, P<0.001). The incidences of adverse events at 6 months were equivalent in the two treatment groups, with the exception of restenosis, which occurred more frequently in the balloon-angioplasty group (P<0.001). Conclusions: In this study, percutaneous revision of venous anastomotic stenosis in patients with a prosthetic hemodialysis graft was improved with the use of a stent graft, which appears to provide longer-term and superior patency and freedom from repeat interventions than standard balloon angioplasty. (ClinicalTrials.gov number, NCT00678249.)

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