Haskal ZJ,Trerotola S,Dolmatch B,et al. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med. 2010;362:494-503

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.)

Keywords

Hemodialysis fistula graft vascular access dialysis access stent-graft failing thrombosed balloon angioplasty

References

Georgiadis GS , Lazarides MK , Panagoutsos SA , et al. Surgical revision of complicated false and true vascular access-related aneurysms. J Vasc Surg. 2008;47:1284-1291.

Hingorani A. , Ascher E. , Kallakuri S. , Greenberg S. , Khanimov Y. Impact of reintervention for failing upper-extremity arteriovenous autogenous access for hemodialysis. J Vasc Surg. 2001 ;34:1004-1009.

Georgiadis GS , Lazarides MK , Lambidis CD , et al. Use of short PTFE segments (<6 cm) compares favorably with pure autologous repair in failing or thrombosed native arteriovenous fistulas. J Vasc Surg. 2005;41:76-81.

Vesely TM Use of stent grafts to repair hemodialysis graft-related pseudoaneurysms. J Vasc Interv Radiol. 2005;16: 1301-1307.

Haskal ZJ , Trerotola S. , Dolmatch B. , et al. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med. 2010;362:494-503.

Clinical practice guidelines for hemodialysis adequacy, update 2006. Am J Kidney Dis. 2006;48(suppl 1): S176-S247.

Brooks JL , Sigley RD , May KJJr , Mack RM Transluminal angioplasty versus surgical repair for stenosis of hemodialysis grafts. A randomized study. Am J Surg. 1987 ;153: 530-531.

Sands JJ , Miranda CL Prolongation of hemodialysis access survival with elective revision. Clin Nephrol. 1995;44: 329-333.

Beathard GA Percutaneous angioplasty for the treatment of venous stenosis: a nephrologists view. Semin Dial. 1995;8: 166-170.

10.

Roberts AB , Kahn MB , Bradford S. , et al. Graft surveillance and angioplasty prolongs dialysis graft patency . J Am Coll Surg. 1996;183:486-492.

11.

Hodges TC , Fillinger MF , Zwolak RM , Walsh DB , Bech F. , Cronenwett JL Longitudinal comparison of dialysis access methods: risk factors for failure . J Vasc Surg. 1997;26:1009-1019.

12.

Polo JR , Echenagusia A. , Menarguez C. , Polo J. , Sanabia J. , Jimenez P. Bypass to a proximal vein to treat peripheral venous stenosis in PTFE grafts for hemodialysis. In: Henry ML , Ferguson RM , eds. Vascular Access for Hemodialysis . 1st ed. Tucson, AZ: W. L. Gore & Associates, Inc and Precept Press; 1997 :127-136.

13.

Dember LM , Holmberg EF , Kaufman JS Randomized controlled trial of prophylactic repair of hemodialysis arteriovenous graft stenosis. Kidney Int. 2004;66:390-398.

14.

Green LD , Lee DS , Kucey DS A meta-analysis comparing surgical thrombectomy, mechanical thrombectomy, and pharmacomechanical thrombolysis for thrombosed dialysis grafts. J Vasc Surg. 2002;36:939-945.

15.

Uflacker R. , Rajagopalan PR , Selby JB , Hannegan C. ; Investigators of the Clinical Trial Sponsored by Microvena Corporation. Thrombosed dialysis access grafts: randomized comparison of the Amplatz thrombectomy device and surgical thromboembolectomy . Eur Radiol. 2004;14: 2009-2014.

16.

Tordoir JH , Bode AS , Peppelenbosch N. , van der Sande FM , de Haan MW Surgical or endovascular repair of thrombosed dialysis vascular access: is there any evidence? J Vasc Surg. 2009;50:953-956.

17.

Allon M. , Robbin ML Hemodialysis vascular access monitoring: current concepts. Hemodial Int. 2009;13:153-162.

18.

Casey ET , Murad MH , Rizvi AZ , et al. Surveillance of arteriovenous hemodialysis access: a systematic review and meta-analysis. J Vasc Surg. 2008 ;48(5 suppl):48S-54S.

19.

Kerlan RK Jr , LaBerge JM Fistula first, stent graft second. N Engl J Med. 2010;362:550-552.

20.

Schuman E. , Quinn S. , Standage B. , Gross G. Thrombolysis versus thrombectomy for occluded hemodyalisis grafts. Am J Surg. 1994;167:473-476.

21.

Vesely TM , Idso MC , Audrain J. , Windus DW , Lowell JA Thrombolysis versus surgical thrombectomy for the treatment of dialysis graft thrombosis: pilot study comparing costs. J Vasc Interv Radiol . 1996;7:507-512.

22.

Marston WA , Criado E. , Jaques PF , Mauro MA , Burnham SJ , Keagy BA Prospective randomized comparison of surgical versus endovascular management of thrombosed dialysis access grafts. J Vasc Surg. 1997;26:373-380.

23.

Vesely TM , Williams D. , Weiss M. , et al. Comparison of the angiojet rheolytic catheter to surgical thrombectomy for the treatment of thrombosed hemodialysis grafts. Peripheral AngioJet Clinical Trial. J Vasc Interv Radiol. 1999;10: 1195-1205.