Table 2.
Study Outcomes
| Outcomes | Fish Oil [95% CI] | Placebo [95% CI] | Group comparison [95% CI] (P-value) |
|---|---|---|---|
| Primary study outcome: Proportion of patients with loss of native patency1 | 48/99 (48%) [0.38–0.59] | 60/97 (62%) [0.51–0.72] | 2 RR = 0.78 [0.60–1.03] (0.064) |
| Secondary and tertiary AV-graft outcomes: | |||
| Primary event rate: primary events3 per 1,000 access days | 3.43 [2.78–4.19] | 5.95 [5.00–7.03] | 4 IRR = 0.58 [0.44–0.75] (<0.001) |
| Primary unassisted patency at 12-months (without loss of native patency) | 0.48 [0.38–0.58] | 0.32 [0.23–0.43] | 5 HR = 0.68 [0.46–0.99] (0.045) |
| Cumulative patency at 12-months | 0.72 [0.62–0.80] | 0.65 [0.54–0.74] | 5 HR = 0.76 [0.46–1.27] (0.30) |
| Thrombosis events | |||
| Proportion of patients with at least one thrombosis event | 33/99 (33%) [0.24–0.44] | 45/97 (46%) [0.36–0.57] | 2 RR = 0.72 [0.49–1.04] (0.080) |
| Thrombosis rate: thromboses per 1,000 access days | 1.71 [1.26–2.27] | 3.41 [2.70–4.24] | 4 IRR = 0.50 [0.35–0.72] (<0.001) |
| Thrombosis–free at 12-months | 0.64 [0.53–0.73] | 0.47 [0.36–0.58] | 5 HR = 0.62 [0.39–0.97] (0.033) |
| Radiological or surgical interventions | |||
| Proportion of patients with at least one intervention | 38/99 (38%) [0.29–0.49] | 48/97 (49%) [0.39–0.60] | 2 RR = 0.78 [0.55–1.09] (0.15) |
| Intervention rate: interventions per 1,000 access days | 2.89 [2.30–3.59] | 4.92 [4.06–5.90] | 4 IRR = 0.59 [0.44–0.78] (<0.001) |
| Intervention-free at 12-months | 0.56 [0.44–0.66] | 0.38 [0.27–0.50] | 5 HR = 0.68 [0.44–1.03] (0.069) |
| Cardiovascular Outcomes7 | |||
| Proportion of patients with at least one cardiovascular event | 9/99 (9%) [0.04–0.17] | 17/97 (18%) [0.11–0.27] | 2 RR = 0.52 [0.22–1.17] (0.10) |
| Cardiovascular event rate: events per 1,000 access days | 0.39 [0.20–0.70] | 0.95 [0.59–1.44] | 4 IRR = 0.41 [0.20–0.85] (0.017) |
| Cardiovascular event-free at 12-months | 0.88 [0.77–0.93] | 0.75 [0.63–0.84] | 5 HR = 0.43 [0.19–0.96] (0.035) |
| Blood pressure and anti-hypertensive medications | |||
| Mean change in SBP from baseline to 6 months | −5.11 [−9.90–−0.33] | +2.63 [−1.8–7.02] | 6 Mean = −7.74 [−14.2–−1.30] (0.018) |
| Mean change in SBP from baseline to 12 months | −3.61 [−8.73–1.52] | +4.49 [−0.72–9.71] | 6 Mean = −8.10 [−15.4–−0.85] (0.014) |
| Mean change in DBP from baseline to 6 months | −3.85 [−6.56–−1.13] | +0.63 [−2.04–3.29] | 6 Mean = −4.47 [−8.25–−0.70] (0.044) |
| Mean change in DBP from baseline to 12 months | −2.17 [−4.77–0.42] | +0.13 [−2.43–2.68] | 6 Mean = −2.30 [−5.91–1.31] (0.13) |
| Proportion of patients who had at least one reduction in dose or frequency of anti-hypertensive medications | 63/99 (64%) [0.53–0.73] | 41/97 (42%) [0.32–0.53] | 2 RR = 1.51 [1.13–2.01] (0.004) |
| Mean reduction in number of anti-hypertensive medications | 1.68 [1.25–2.10] | 0.62 [0.37–0.87] | 6 Mean = 1.06 [0.57–1.55] (<0.001) |
1
Experienced at least one of thrombosis or radiological intervention or surgical intervention
2
Relative risk group comparison, Fisher’s exact test P-value
3
Primary event is a thrombosis or radiological intervention or surgical intervention
4
Incidence rate ratio (IRR) group comparison of fish oil relative to placebo, Poisson regression P-value
5
Hazard ratio group comparison, Log-rank test P-value
6
Mean change from baseline to 6 and 12 month values are reported; Wilcoxon rank sum test P-value
7
Stroke, peripheral vascular disease, myocardial infarction, congestive heart failure, cardiac related death