Ashley B Irish1, Andrea K Viecelli2, Carmel M Hawley2, Lai-Seong Hooi3, Elaine M Pascoe4, Peta-Anne Paul-Brent4, Sunil V Badve5, Trevor A Mori6, Alan Cass7, Peter G Kerr8, David Voss9, Loke-Meng Ong10, Kevan R Polkinghorne11. 1. Department of Nephrology, Fiona Stanley Hospital, Perth, Australia2School of Medicine and Pharmacology, University of Western Australia, Perth, Australia. 2. Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia4Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Australia. 3. Department of Medicine and Hemodialysis Unit, Hospital Sultanah Aminah, Johor Bahru, Malaysia. 4. Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Australia. 5. Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Australia6Department of Nephrology, St George Hospital, Sydney, Australia7The George Institute for Global Health, Sydney, Australia. 6. School of Medicine and Pharmacology, University of Western Australia, Perth, Australia. 7. Menzies School of Health Research, Charles Darwin University, Darwin, Australia. 8. Department of Nephrology, Monash Medical Centre, Melbourne, Australia10Department of Medicine, Monash University, Melbourne, Australia. 9. Middlemore Renal Department, Counties-Manukau Health, Auckland, New Zealand. 10. Department of Nephrology, Penang Hospital, Georgetown, Malaysia. 11. Department of Nephrology, Monash Medical Centre, Melbourne, Australia10Department of Medicine, Monash University, Melbourne, Australia13School of Public Health and Preventive Medicine, Monash University, Melbourne, 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.
RCT Entities:
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 aspirinimpairs 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.
Authors: Emma Aitken; Rachel Kearns; Lucian Gaianu; Andrew Jackson; Mark Steven; John Kinsella; Marc Clancy; Alan Macfarlane Journal: J Am Soc Nephrol Date: 2020-07-24 Impact factor: 10.121
Authors: Yong Pey See; Yeoungjee Cho; Elaine M Pascoe; Alan Cass; Ashley Irish; David Voss; Kevan R Polkinghorne; Lai Seong Hooi; Loke-Meng Ong; Peta-Anne Paul-Brent; Peter G Kerr; Trevor A Mori; Carmel M Hawley; David W Johnson; Andrea K Viecelli Journal: Kidney360 Date: 2020-09-14
Authors: Jie Cui; Chase W Kessinger; Harkamal S Jhajj; Madeleine S Grau; Sanjay Misra; Peter Libby; Jason R McCarthy; Farouc A Jaffer Journal: J Am Soc Nephrol Date: 2020-03-09 Impact factor: 10.121
Authors: Christoph B Olivier; Vandana Sundaram; Glenn M Chertow; Sumana Shashidhar; Lori K McDonnell; Victoria Y Ding; Manisha Desai; Kenneth W Mahaffey; Matthew Mell Journal: J Vasc Access Date: 2019-11-27 Impact factor: 2.283