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Randomized Controlled Trial
. 2009 May 21;360(21):2191-201.
doi: 10.1056/NEJMoa0805840.

Effect of dipyridamole plus aspirin on hemodialysis graft patency

Bradley S Dixon  1 , Gerald J Beck, Miguel A Vazquez, Arthur Greenberg, James A Delmez, Michael Allon, Laura M Dember, Jonathan Himmelfarb, Jennifer J Gassman, Tom Greene, Milena K Radeva, Ingemar J Davidson, T Alp Ikizler, Gregory L Braden, Andrew Z Fenves, James S Kaufman, James R Cotton Jr, Kevin J Martin, James W McNeil, Asif Rahman, Jeffery H Lawson, James F Whiting, Bo Hu, Catherine M Meyers, John W Kusek, Harold I Feldman; DAC Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Effect of dipyridamole plus aspirin on hemodialysis graft patency

Bradley S Dixon et al. N Engl J Med. .

Abstract

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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Conflict of interest statement

No other potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1. Study Enrollment and Follow-up
NSAID denotes nonsteroidal antiinflammatory drug.
Figure 2
Figure 2. Kaplan–Meier Estimates of the Cumulative Incidence of Loss of Primary Unassisted Graft Patency, According to Study Group
The median duration of patency was 5.8 months (95% confidence interval [CI], 4.3 to 7.1) in the extended-release dipyridamole (ERDP)–aspirin group and 4.3 months (95% CI, 3.6 to 5.4) in the placebo group.
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