Journal article
Effect of Clopidogrel on Early Failure of Arteriovenous Fistulas for Hemodialysis : A Randomized Controlled Trial
JAMA : the journal of the American Medical Association, Vol.299(18), pp.2164-2171
2008
DOI: 10.1001/jama.299.18.2164
PMCID: PMC4943222
PMID: 18477783
Abstract
Context The arteriovenous fistula is the preferred type of vascular access for hemodialysis because of lower thrombosis and infection rates and lower health care expenditures compared with synthetic grafts or central venous catheters. Early failure of fistulas due to thrombosis or inadequate maturation is a barrier to increasing the prevalence of fistulas among patients treated with hemodialysis. Small, inconclusive trials have suggested that antiplatelet agents may reduce thrombosis of new fistulas.
Objective To determine whether clopidogrel reduces early failure of hemodialysis fistulas.
Design, Setting, and Participants Randomized, double-blind, placebo-controlled trial conducted at 9 US centers composed of academic and community nephrology practices in 2003-2007. Eight hundred seventy-seven participants with end-stage renal disease or advanced chronic kidney disease were followed up until 150 to 180 days after fistula creation or 30 days after initiation of dialysis, whichever occurred later.
Intervention Participants were randomly assigned to receive clopidogrel (300-mg loading dose followed by daily dose of 75 mg; n = 441) or placebo (n = 436) for 6 weeks starting within 1 day after fistula creation.
Main Outcome Measures The primary outcome was fistula thrombosis, determined by physical examination at 6 weeks. The secondary outcome was failure of the fistula to become suitable for dialysis. Suitability was defined as use of the fistula at a dialysis machine blood pump rate of 300 mL/min or more during 8 of 12 dialysis sessions.
Results Enrollment was stopped after 877 participants were randomized based on a stopping rule for intervention efficacy. Fistula thrombosis occurred in 53 (12.2%) participants assigned to clopidogrel compared with 84 (19.5%) participants assigned to placebo (relative risk, 0.63; 95% confidence interval, 0.46-0.97; P = .018). Failure to attain suitability for dialysis did not differ between the clopidogrel and placebo groups (61.8% vs 59.5%, respectively; relative risk, 1.05; 95% confidence interval, 0.94-1.17; P = .40).
Conclusion Clopidogrel reduces the frequency of early thrombosis of new arteriovenous fistulas but does not increase the proportion of fistulas that become suitable for dialysis.
Details
- Title: Subtitle
- Effect of Clopidogrel on Early Failure of Arteriovenous Fistulas for Hemodialysis : A Randomized Controlled Trial
- Creators
- Laura M DEMBER - Boston University, United StatesGerald J BECK - Cleveland Clinic Foundation, Cleveland, Ohio, United StatesMilena K RADEVA - Cleveland Clinic Foundation, Cleveland, Ohio, United StatesGregory L BRADEN - Baystate Medical Center, Springfield, Massachusetts, United StatesT Alp Ikizler - Vanderbilt University, Nashville, Tennessee, United StatesMichael V ROCCO - Wake Forest University, Winston-Salem, North Carolina, United StatesIngemar J DAVIDSON - University of Texas-Southwestern, Dallas, United StatesJames S KAUFMAN - Boston University, United StatesCatherine M MEYERS - National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, United StatesJohn W KUSEK - National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, United StatesHarold I FELDMAN - University of Pennsylvania, Philadelphia, United StatesMichael ALLON - University of Alabama, Birmingham, United StatesJames A DELMEZ - Washington University in St Louis, St Louis, Missouri, United StatesBradley S DIXON - University of Iowa, Iowa City, United StatesArthur GREENBERG - Duke University, Durham, North Carolina, United StatesJonathan HIMMELFARB - Maine Medical Center, Portland, United StatesMiguel A VAZQUEZ - University of Texas-Southwestern, Dallas, United StatesJennifer J GASSMAN - Cleveland Clinic Foundation, Cleveland, Ohio, United StatesTom GREENE - University of Utah, Salt Lake City, United StatesDialysis Access Consortium (DAC) Study Group
- Resource Type
- Journal article
- Publication Details
- JAMA : the journal of the American Medical Association, Vol.299(18), pp.2164-2171
- Publisher
- American Medical Association
- DOI
- 10.1001/jama.299.18.2164
- PMID
- 18477783
- PMCID
- PMC4943222
- ISSN
- 0098-7484
- eISSN
- 1538-3598
- Language
- English
- Date published
- 2008
- Academic Unit
- Nephrology; Internal Medicine
- Record Identifier
- 9984094874602771
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