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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
[ClinicalTrials.gov]
.)
Source Information
From the University of Iowa and the Veterans Affairs Medical Center, Iowa City (B.S.D.); Cleveland Clinic Foundation, Cleveland (G.J.B., J.J.G., M.K.R., B.H.); University of Texas Southwestern Medical Center (M.A.V., I.J.D.) and Baylor Medical Center (A.Z.F.) — both in Dallas; Tyler Nephrology Associates, Tyler, TX (J.R.C.); Duke University, Durham, NC (A.G., J.H.L.); Washington University in St. Louis (J.A.D.) and Saint Louis University (K.J.M.) — both in St. Louis; University of Alabama at Birmingham, Birmingham (M.A.); Boston University, Boston (L.M.D., J.S.K.); Maine Medical Center, Portland (J.H., J.F.W.); University of Utah, Salt Lake City (T.G.); Vanderbilt University, Nashville (T.A.I.); Baystate Medical Center, Springfield, MA (G.L.B.); Vascular Surgery Associates, Baton Rouge, LA (J.W.M.); Charleston Area Medical Center, Charleston, WV (A.R.); National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD (C.M.M., J.W.K.); and University of Pennsylvania, Philadelphia (H.I.F.).
Address reprint requests to Dr. Dixon at the University of Iowa College of Medicine, E-300D GH, 200 Hawkins Dr., Iowa City, IA 52242-1081, or at bradley-dixon{at}uiowa.edu.
Related Letters:
Dipyridamole plus Aspirin and Hemodialysis Graft Patency
Weale A. R., Cooper D. G., Hentschel D. M., Dixon B. S., Feldman H. I.
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N Engl J Med 2009;
361:720-721, Aug 13, 2009.
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