Doi 2014.
| Methods | RCT, parallel, (n3 EPA vs nil, both with statins), 12 months Summary risk of bias: moderate or high |
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| Participants | Patients having PCI after acute MI N: 119 intervention, 119 control analysed Level of risk for CVD: high Male: 77% intervention, 76% control Mean age (SD): 70 (11) intervention, 71 (12) control Age range: unclear Smokers: 28% intervention, 32% control Hypertension: 71% intervention, 69% control Medications taken by ≥ 50% of those in the control group: aspirin, ticlopidine, ß‐blockers, statins (as part of treatment) Medications taken by 20%‐49% of those in the control group: ARB/ ACE inhibitors Medications taken by some, but < 20% of the control group: none Location: Japan Ethnicity: not reported |
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| Interventions | Type: supplement (EPA) Comparison: EPA vs nil Intervention: purified EPA ethyl esters (> 98%) 1.8 g/d EPA within 24 h after PCI plus statins Control: statins with no EPA Dose aim: increase 1.8 g/d EPA + DHA, 0.8% E n‐3, 0.8 %E PUFA Baseline PUFA: unclear Compliance by biomarkers: plasma EPA reported at 6‐8 months, higher in intervention (162.8 mg/L) than control (65.5 mg/L). No further biomarker or TC data reported Compliance by dietary intake: not reported
Compliance, other measures: not reported Inclusion basis: no intention to increase total PUFA. Intention was to increase omega‐3 by 0.8% E. Total PUFA appear to be 0.8% E higher in intervention, > 10% more than assumed 6% E baseline PUFA dose: 0.8% E Length of intervention: 12 months |
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| Outcomes | Main trial outcome: CV events Dropouts: 1 intervention, 2 control Available outcomes: mortality, stroke, MI, sudden death, CV death, revascularisation Response to contact: contact attempted but no response to date. |
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| Notes | Trial funding: trial registry states "self‐funded". The trial authors received honoraria from Mochida Pharmaceutical Co. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computer‐generated randomisation plan, which included stratification by age and sex. |
| Allocation concealment (selection bias) | Unclear risk | Carried out by research technician but unclear |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label but blind endpoint |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Data on outcomes were collected from clinical charts. Unclear if blinded. Diagnoses were confirmed by investigator blind to treatment allocation. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 3 dropouts, similar rates between the groups and reasons given |
| Selective reporting (reporting bias) | High risk | Data collection completed before trial registry entry. Only 1% dropout |
| Attention bias | Low risk | Timing of follow‐ups similar |
| Compliance | Unclear risk | Plasma EPA reported at 6‐8 months, higher in intervention (162.8 mg/L) than control (65.5 mg/L). No further biomarker or TC data reported |
| Other bias | Low risk | None observed |