Journal article
Effect of Dipyridamole plus Aspirin on Hemodialysis Graft Patency
The New England journal of medicine, Vol.360(21), pp.2191-2201
2009
DOI: 10.1056/NEJMoa0805840
PMCID: PMC3929400
PMID: 19458364
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.
Details
- Title: Subtitle
- Effect of Dipyridamole plus Aspirin on Hemodialysis Graft Patency
- Creators
- Bradley S DIXON - University of lowa and the Veterans Affairs Medical Center, lowa City, United StatesGerald J BECK - Cleveland Clinic Foundation, Cleveland, United StatesMilena K RADEVA - Cleveland Clinic Foundation, Cleveland, United StatesIngemar J DAVIDSON - University of Texas Southwestern Medi- cal Center, United StatesT Alp Ikizler - Vanderbilt University, Nashville, United StatesGregory L BRADEN - Baystate Medical Center, Spring- field, MA, United StatesDAC Study GroupJames S KAUFMAN - Boston University, Boston, United StatesJames R COTTON - Tyler Nephrology Associates, Tyler, TX, United StatesKevin J MARTIN - Saint Louis University, St. Louis, United StatesJames W MCNEIL - Vascular Surgery Asso- ciates, Baton Rouge, LA, United StatesAsif RAHMAN - Charles- ton Area Medical Center, Charleston, WV, United StatesMiguel A VAZQUEZ - University of Texas Southwestern Medi- cal Center, United StatesJeffery H LAWSON - Duke University, Durham, NC, United StatesJames F WHITING - Maine Medical Center, Portland, United StatesBo Hu - Cleveland Clinic Foundation, Cleveland, United StatesCatherine M MEYERS - National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, United StatesJohn W KUSEK - National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, United StatesHarold I FELDMAN - University of Penn- sylvania, Philadelphia, United StatesArthur GREENBERG - Duke University, Durham, NC, United StatesJames A DELMEZ - Washington University, St. Louis, United StatesMichael ALLON - University of Alabama at Birmingham, Birmingham, United StatesLaura M DEMBER - Boston University, Boston, United StatesJonathan HIMMELFARB - Maine Medical Center, Portland, United StatesJennifer J GASSMAN - Cleveland Clinic Foundation, Cleveland, United StatesTom GREENE - University of Utah, Salt Lake City, United StatesDAC Study Grp
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.360(21), pp.2191-2201
- Publisher
- Massachusetts Medical Society
- DOI
- 10.1056/NEJMoa0805840
- PMID
- 19458364
- PMCID
- PMC3929400
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Language
- English
- Date published
- 2009
- Academic Unit
- Anatomy and Cell Biology; Nephrology; Internal Medicine
- Record Identifier
- 9984094664002771
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