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Effect of dipyridamole plus aspirin on hemodialysis graft patency.

Publication ,  Journal Article
Dixon, BS; Beck, GJ; Vazquez, MA; Greenberg, A; Delmez, JA; Allon, M; Dember, LM; Himmelfarb, J; Gassman, JJ; Greene, T; Radeva, MK; Rahman, A ...
Published in: N Engl J Med
May 21, 2009

BACKGROUND: Arteriovenous graft stenosis leading to thrombosis is a major cause of complications in patients undergoing hemodialysis. Procedural interventions may restore patency but are costly. Although there is no proven pharmacologic therapy, dipyridamole may be promising because of its known vascular antiproliferative activity. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of extended-release dipyridamole, at a dose of 200 mg, and aspirin, at a dose of 25 mg, given twice daily after the placement of a new arteriovenous graft until the primary outcome, loss of primary unassisted patency (i.e., patency without thrombosis or requirement for intervention), was reached. Secondary outcomes were cumulative graft failure and death. Primary and secondary outcomes were analyzed with the use of a Cox proportional-hazards regression with adjustment for prespecified covariates. RESULTS: At 13 centers in the United States, 649 patients were randomly assigned to receive dipyridamole plus aspirin (321 patients) or placebo (328 patients) over a period of 4.5 years, with 6 additional months of follow-up. The incidence of primary unassisted patency at 1 year was 23% (95% confidence interval [CI], 18 to 28) in the placebo group and 28% (95% CI, 23 to 34) in the dipyridamole-aspirin group, an absolute difference of 5 percentage points. Treatment with dipyridamole plus aspirin significantly prolonged the duration of primary unassisted patency (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P=0.03) and inhibited stenosis. The incidences of cumulative graft failure, death, the composite of graft failure or death, and serious adverse events (including bleeding) did not differ significantly between study groups. CONCLUSIONS: Treatment with dipyridamole plus aspirin had a significant but modest effect in reducing the risk of stenosis and improving the duration of primary unassisted patency of newly created grafts. (ClinicalTrials.gov number, NCT00067119.)

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 21, 2009

Volume

360

Issue

21

Start / End Page

2191 / 2201

Location

United States

Related Subject Headings

  • Thrombosis
  • Renal Dialysis
  • Proportional Hazards Models
  • Platelet Aggregation Inhibitors
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Incidence
  • Humans
  • Graft Occlusion, Vascular
 

Citation

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Dixon, B. S., Beck, G. J., Vazquez, M. A., Greenberg, A., Delmez, J. A., Allon, M., … DAC Study Group, . (2009). Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med, 360(21), 2191–2201. https://doi.org/10.1056/NEJMoa0805840
Dixon, Bradley S., Gerald J. Beck, Miguel A. Vazquez, Arthur Greenberg, James A. Delmez, Michael Allon, Laura M. Dember, et al. “Effect of dipyridamole plus aspirin on hemodialysis graft patency.N Engl J Med 360, no. 21 (May 21, 2009): 2191–2201. https://doi.org/10.1056/NEJMoa0805840.
Dixon BS, Beck GJ, Vazquez MA, Greenberg A, Delmez JA, Allon M, et al. Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med. 2009 May 21;360(21):2191–201.
Dixon, Bradley S., et al. “Effect of dipyridamole plus aspirin on hemodialysis graft patency.N Engl J Med, vol. 360, no. 21, May 2009, pp. 2191–201. Pubmed, doi:10.1056/NEJMoa0805840.
Dixon BS, Beck GJ, Vazquez MA, Greenberg A, Delmez JA, Allon M, Dember LM, Himmelfarb J, Gassman JJ, Greene T, Radeva MK, Davidson IJ, Ikizler TA, Braden GL, Fenves AZ, Kaufman JS, Cotton JR, Martin KJ, McNeil JW, Rahman A, Lawson JH, Whiting JF, Hu B, Meyers CM, Kusek JW, Feldman HI, DAC Study Group. Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med. 2009 May 21;360(21):2191–2201.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 21, 2009

Volume

360

Issue

21

Start / End Page

2191 / 2201

Location

United States

Related Subject Headings

  • Thrombosis
  • Renal Dialysis
  • Proportional Hazards Models
  • Platelet Aggregation Inhibitors
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Incidence
  • Humans
  • Graft Occlusion, Vascular