Americans have end-stage renal disease, and most are treated with hemodialysis. 1 A major challenge in caring for patients undergoing hemodialysis is maintaining a functioning vascular access, which is essential for performing the dialysis procedure. The effect of vascular access dysfunction is substantial-it is a leading reason for hospitalization among patients with end-stage renal disease and has associated annual costs in the United States that exceed $1 billion. 2,3 For editorial comment see p 2205.Author Affiliations and Members of the Dialysis Access Consortium Study Group are listed at the end of this article.

Fistula maturation requires a compliant and responsive vasculature capable of dilating in response to the increased velocity of blood flowing into the newly created low-resistance circuit. Successful maturation to a high volume flow circuit capable of sustaining hemodialysis typically occurs within the first few weeks after creation. Failure to achieve maturation within 4-8 weeks should prompt a search for reversible etiologies; however, an accepted definition of maturation, particularly for patients not yet on dialysis remains elusive. The most commonly identified etiology is neointimal hyperplasia typically occurring in the juxta-anastomotic vein. However, failed maturation has also been reported secondary to impaired arterial and venous dilation and accessory veins. The exact frequency of each of these etiologies is unclear. Understanding the etiologies of impaired fistula maturation will focus future studies of targeted interventions to improve the rate of fistula maturation and increase the number of dialysis patients with a functioning autogenous fistula.

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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.)