Randomized controlled trial2017

Effect of Fish Oil Supplementation and Aspirin Use on Arteriovenous Fistula Failure in Patients Requiring Hemodialysis: A Randomized Clinical Trial

Irish AB, Viecelli AK, Hawley CM, Hooi LS, Pascoe EM, Paul-Brent PA, Badve SV, Mori TA, Cass A, Kerr PG, Voss D, Ong LM, Polkinghorne KR, Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) Study Collaborative Group

JAMA internal medicine · 79 citations

Review labels

Funding not disclosed

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Clinical events such as disease or death

Who paid for it

Funding
Funding not disclosed

Publication

Published
2017-01-05 · JAMA Intern Med · vol. 177 · issue 2 · p. 184
Publisher
American Medical Association
Cited
105 citations · more than 100% of similar papers · 19.0× the field average
Impact
Top 10% most cited in its field
References
89 works
Access
Free to read
Research areas
Central Venous Catheters and Hemodialysis · Coconut Research and Applications · Fatty Acid Research and Health
Keywords
Medicine, Hemodialysis, Aspirin, Arteriovenous fistula, Fish oil, Surgery, Intensive care medicine, Internal medicine, Fish <Actinopterygii>, Cardiology, Fishery
MeSH
humans, kidney failure, chronic, constriction, pathologic, graft occlusion, vascular, aspirin, fish oils, fibrinolytic agents, treatment outcome, renal dialysis, arteriovenous shunt, surgical, administration, oral, double-blind method, vascular patency, dietary supplements, adult, middle aged, female, male

14 authors

From AU, MY, NZ

  • Ashley Bruce Irish · correspondingThe University of Western Australia; Fiona Stanley Hospital
  • Andrea Katharina ViecelliThe University of Queensland; Princess Alexandra Hospital
  • Carmel Mary HawleyThe University of Queensland; Princess Alexandra Hospital
  • Lai Seong HooiSultanah Aminah Hospital
  • Elaine M. PascoeThe University of Queensland; Kidney Health Australia
  • Peta‐Anne Paul‐BrentThe University of Queensland; Kidney Health Australia

Abstract

Importance

Vascular access dysfunction is a leading cause of morbidity and mortality in patients requiring hemodialysis. Arteriovenous fistulae are preferred over synthetic grafts and central venous catheters due to superior long-term outcomes and lower health care costs, but increasing their use is limited by early thrombosis and maturation failure. ω-3 Polyunsaturated fatty acids (fish oils) have pleiotropic effects on vascular biology and inflammation and aspirin impairs platelet aggregation, which may reduce access failure.

Objective

To determine whether fish oil supplementation (primary objective) or aspirin use (secondary objective) is effective in reducing arteriovenous fistula failure.

Design, setting, and participants

The Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) study was a randomized, double-blind, controlled clinical trial that recruited participants with stage 4 or 5 chronic kidney disease from 2008 to 2014 at 35 dialysis centers in Australia, Malaysia, New Zealand, and the United Kingdom. Participants were observed for 12 months after arteriovenous fistula creation.

Interventions

Participants were randomly allocated to receive fish oil (4 g/d) or matching placebo. A subset (n = 406) was also randomized to receive aspirin (100 mg/d) or matching placebo. Treatment started 1 day prior to surgery and continued for 12 weeks.

Main outcomes and measures

The primary outcome was fistula failure, a composite of fistula thrombosis and/or abandonment and/or cannulation failure, at 12 months. Secondary outcomes included the individual components of the primary outcome.

Results

Of 1415 eligible participants, 567 were randomized (359 [63%] male, 298 [53%] white, 264 [47%] with diabetes; mean [SD] age, 54.8 [14.3] y). The same proportion of fistula failures occurred in the fish oil and placebo arms (128 of 270 [47%] vs 125 of 266 [47%]; relative risk [RR] adjusted for aspirin use, 1.03; 95% CI, 0.86-1.23; P = .78). Fish oil did not reduce fistula thrombosis (60 [22%] vs 61 [23%]; RR, 0.98; 95% CI, 0.72-1.34; P = .90), abandonment (51 [19%] vs 58 [22%]; RR, 0.87; 95% CI, 0.62-1.22; P = .43), or cannulation failure (108 [40%] vs 104 [39%]; RR, 1.03; 95% CI, 0.83-1.26; P = .81). The risk of fistula failure was similar between the aspirin and placebo arms (87 of 194 [45%] vs 83 of 194 [43%]; RR, 1.05; 95% CI, 0.84-1.31; P = .68).

Conclusions and relevance

Neither fish oil supplementation nor aspirin use reduced failure of new arteriovenous fistulae within 12 months of surgery.

Trial registration

anzctr.org.au Identifier: CTRN12607000569404.

Abstract via Europe PMC. Copyright remains with the authors or publisher.

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