Fish oil and aspirin effects on arteriovenous fistula function: Secondary outcomes of the randomised omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) trial

Abstract

BackgroundArteriovenous fistulas (AVF) for haemodialysis often experience early thrombosis and maturation failure requiring intervention and/or central venous catheter (CVC) placement. This secondary and exploratory analysis of the FAVOURED study determined whether omega-3 fatty acids (fish oils) or aspirin affected AVF usability, intervention rates and CVC requirements.MethodsIn 567 adult participants planned for AVF creation, all were randomised to fish oil (4g/d) or placebo, and 406 to aspirin (100mg/d) or placebo, starting one day pre-surgery and continued for three months. Outcomes evaluated within 12 months included AVF intervention rates, CVC exposure, late dialysis suitability failure, and times to primary patency loss, abandonment and successful cannulation.ResultsFinal analyses included 536 participants randomised to fish oil or placebo (mean age 55 years, 64% male, 45% diabetic) and 388 randomised to aspirin or placebo. Compared with placebo, fish oil reduced intervention rates (0.82 vs 1.14/1000 patient-days, incidence rate ratio [IRR] 0.72, 95% confidence interval [CI] 0.54–0.97), particularly interventions for acute thrombosis (0.09 vs 0.17/1000 patient-days, IRR 0.53, 95% CI 0.34–0.84). Aspirin significantly reduced rescue intervention rates (IRR 0.45, 95% CI 0.27–0.78). Neither agent significantly affected CVC exposure, late dialysis suitability failure or time to primary patency loss, AVF abandonment or successful cannulation.ConclusionAlthough fish oil and low-dose aspirin given for 3 months reduced intervention rates in newly created AVF, they had no significant effects on CVC exposure, AVF usability and time to primary patency loss or access abandonment. Reduction in access interventions benefits patients, reduces costs and warrants further study.

Trends in Adaptive Design Methods in Dialysis Clinical Trials: A Systematic Review

“…Group sequential designs were the most common type of adaptive design method used; 35 (61.4%) trials (22 [71%] in dialysis populations and 13 [50%] in dialysis outcome trials; Table 1 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 ). The O’Brien-Fleming stopping boundary was the most common stopping rule, used in 9 trials (25.7%), followed by Lan DeMets, used in 8 trials (22.9%).…”

“…of end points Patients with ADPKD Lisinopril and telmisartan Medication Time to death, ESKD, or 50% reduction from baseline eGFR. HD 486 US Public NIDDK Phase 3 Knoll et al 58 , 59 (2015) O Brien-Fleming boundary Extended follow-up to 4 y to increase statistical power due to slower-than-expected recruitment Kidney transplant patients with proteinuria and eGFR of 20-55 mL/min/1.73 m 2 Ramipril Medication Doubling of Scr, ESKD, or death HD 528 Canada Public Canadian Institutes of Health Research Phase 3 PAVE 60 (2016) Lan DeMets Trial not complete Patients with native arteriovenous fistula Paclitaxel-coated balloons Medical device Time to end of target lesion primary patency HD 211 UK Public National Institute for Health Research EME programme Phase 3 OPN-305 (NCT01794663) (2016) NR Unknown Kidney transplant recipients with delayed graft function OPN-305 (tomaralimab) Medication Measure of early graft function HD 252 Ireland Industry Opsona Therapeutics Ltd Phase 2 FAVOURED 61 , 62 (2017) Haybittle-Peto rule Early cessation of recruitment, only interim analysis 1 was performed Participants with stage 4 or 5 CKD after arteriovenous fistula creation Fish oil supplementation Medication Fistula failure, a composite of fistula thrombosis and/or abandonment and/or cannulation failure, at 12 mo HD 567 Australia Public and private National Health and Medical Research Council of Australia; Amgen Australia Pty Ltd; Mylan EPD Phase...…”

Monitoring the Patient Following Radio-Cephalic Arteriovenous Fistula Creation: Current Perspectives

“…The drugs analysed are antiplatelet/anticoagulant, calcium channel blockers (CCB) angiotensin converting enzyme inhibitor (ACE-I) and angiotensin II receptor blockers (ARB), statins, fish oil, prednisolone or phytochemical constituents (iontophoretic injection of Salvia miltiorrhiza). [30][31][32] Currently there are not enough evidence to recommend antiplatelet treatment to reduce AVF thrombosis or improve maturation. Double therapy (aspirin plus clopidogrel) and monotherapy with warfarin significantly increased the risk of bleeding.…”

“…As to use of statins, fish oil, prednisolone or phytochemical constituents (iontophoretic injection of Salvia miltiorrhiza), clinical studies are not conclusive and their use is not recommended by European Renal Best Practice (ERBP) 4 guideline vascular access. [30][31][32] Some interesting results have been obtained in the field of exercise on the AVF hand.…”

Expert consensus on the establishment and maintenance of native arteriovenous fistula

“…Similarly, the use of fish oil (HR = 0.92, 95% CI: 0.69–1.21, P = 0.53) or aspirin (HR = 1.01, 95% CI: 0.73–1.42, P = 0.94) did not change the time to primary failure or time to abandonment of AVF. 60 A domestic prospective cohort study 61 included 406 HD patients with an observation period of 5 years. The patients were divided into aspirin (100 mg/d) group and non-aspirin group.…”