Dipyridamole Plus Aspirin Prolongs Duration of Primary Unassisted Graft Patency
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Dipyridamole Plus Aspirin Prolongs Duration of Primary Unassisted Graft Patency

NEW YORK -- May 21, 2009 -- Treatment with dipyridamole plus aspirin has a significant but modest effect in reducing the risk of stenosis and improving the duration of primary unassisted patency of newly created grafts, according to a study published in the May 21 issue of the New England Journal of Medicine.

The Dialysis Access Consortium (DAC) trial found that the combination treatment decreased the rate of loss of primary unassisted graft patency by 18% and the rate of developing significant stenosis by 28%, compared with placebo.

Previous smaller trials of anti-clotting therapies failed to show that these drugs improve arteriovenous (AV) graft patency or that they could be used safely in patients on dialysis.

"Our trial results show that we now have a drug therapy that significantly prolongs the viability of AV grafts," said lead author Bradley S. Dixon, MD, University of Iowa College of Medicine, Iowa City, Iowa. "This is an important step forward as we proceed to develop therapies to improve dialysis patients' quality of life."

The study included 649 patients with new AV grafts from 13 clinical sites in the US who were randomly assigned to receive dipyridamole 200 mg plus aspirin 25 mg or to a placebo given twice daily after the placement of a new AV graft.

Treatment continued until loss of primary unassisted patency was reached (primary outcome). The trial took place over a period of 5 years.

The incidence of primary unassisted patency at 1 year was 23% (95% confidence interval [CI], 18-28) in the placebo group and 28% (95% CI, 23-34) in the dipyridamole/aspirin group.

Treatment with dipyridamole plus aspirin significantly prolonged the duration of primary unassisted patency (hazard ratio = 0.82; 95% CI, 0.68-0.98; P = .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.

"This drug combination provides a modest but important new therapy to keep AV grafts in good working order so patients can get the dialysis they need," said Griffin P. Rodgers, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, Rockville, Maryland. "But clearly more research is needed to extend the useful life of AV grafts."

SOURCE: National Institutes of Health

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