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Study Title and Description

Effect of dietary supplementation with n-3 fatty acids on coronary artery bypass graft patency.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effect of dietary supplementation with n-3 fatty acids on coronary artery bypass graft patency.
Author Eritsland J., Arnesen H., Grønseth K., Fjeld NB., Abdelnoor M.
Country Department of Cardiology, Ullevål University Hospital, Oslo, Norway.
Year 1996
Numbers Pubmed ID: 8540453
16794 (internal)

Secondary Publication Information
UI Title Author Country Year
Long-term metabolic effects of n-3 polyunsaturated fatty acids in patients with coronary artery disease. Eritsland J., Arnesen H., Seljeflot I., Høstmark AT. Department of Cardiology, Ullevål University Hospital, Oslo, Norway. 1995
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA) with aspirin or warfarin
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2 No intervention with warfarin or aspirin
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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What is the name of this study? (e.g. DART, Physician's Health Study) Shunt Occlusion Trial (SHOT)
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Country in which study conducted (where subjects live) Norway
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Funding source Industry funded
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Eligibility Criteria: consecutive patients admitted for coronary artery bypass grafting without concomitant cardiac surgery, such as valve implantation or aneurysmectomy. Exclusion criteria: medical contraindications to any of the treatment principles (n = 109), refused participation (n = 57), early (~2 days) perioperative death (n = 13) or complications (n = 32), presumed lack of compliance (n = 29), indication for anticoagulation (n = 27), and administrative reasons (n = 38).
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Study Population Secondary Prevention (history of CVD event)
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Duration of Intervention 1 year
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Cardiac disease ... coronary artery bypass grafting without concomitant cardiac surgery
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Conflict of interest No Data regarding conflict of interest
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Does the study report a subgroup analysis for an outcome of interest? No
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Does the study report a regression analysis with interaction terms for an outcome of interest? No
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Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
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Study start date(s) 1989
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 4.2 9.6
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20 24.7
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Baseline characteristics, continuous 59.9 59.4
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8.7 8.8
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144 146
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88 88
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nd nd
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6.54 6.55
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mmol/L mmol/L
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1.14 1.16
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4.59 4.61
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mmol/L mmol/L
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0.97 1.09
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1.06 1.00
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mmol/L mmol/L
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0.31 0.27
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1.94 2.09
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mmol/L mmol/L
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1.05 1.07
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25.4 25.5
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2.7 2.8
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Male, percent 85.8 87.6
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Race nd nd
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Comments about baseline data No data entered.
Baseline diet description See table 2 See table 2
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Baseline omega-3 intake Total n-3: 2.7 g/d (1.4) Total n-3: 2.5 g/d (1.4)
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Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons


Results Data
Outcome: Death      Population: 51524
Time Point Measure "Fish oil" (DHA+EPA) No intervention


1 years

N Enrolled 317 293
Counts 8 6
Outcome: lipid      Population: 51525
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed 260 251
Mean 1.06 1.00
SD 0.31 0.27


9 months

N Analyzed 260 251
Mean 1.16 1.08
SD 0.33 0.28
Outcome: lipid      Population: 51526
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed 260 251
Mean 4.59 4.61
SD 0.97 1.09


9 months

N Analyzed 260 251
Mean 5.11 5.03
SD 1.18 1.25
Outcome: lipid      Population: 51527
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed 260 251
Mean 1.94 2.09
SD 1.05 1.07


9 months

N Analyzed 260 251
Mean 1.57 2.08
SD 0.86 1.26

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? UNCLEAR
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Was ALLOCATION adequately concealed (prior to assignment)? LOW
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Were PARTICIPANTS adequately BLINDED? UNCLEAR
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Were OUTCOME ASSESSORS adequately BLINDED? UNCLEAR
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data LOW
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
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INTENTION-TO-TREAT analysis? (Yes/No) No Yes for deaths, but lipid outcomes are based on completers only
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Group SIMILARITY AT BASELINE (**GENERAL**) LOW
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Was there incomplete COMPLIANCE with interventions across groups? LOW
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Group SIMILARITY AT BASELINE (**OMEGA-3**) LOW
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes
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If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes
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Quality Rating
No quality rating data was found.