Do fish oils prevent restenosis after coronary angioplasty?
What this study found
High-dose fish oil did not reduce restenosis after PTCA. At 6 months, restenosis was 52% with fish oil versus 46% with corn oil placebo among analyzable patients, with no significant difference (P=.37); the reported 95% confidence interval for the decrease in risk was -37% to +6%. Adverse events were similar between groups, and no fish-oil-related safety signal was identified. The authors concluded that fish oil supplementation did not prevent restenosis after PTCA.
- Study & population
- Multicenter randomized trial in adults scheduled for elective percutaneous transluminal coronary angioplasty of native coronary arteries.
- Intervention
- Fish oil was given orally as ten 1-g gelatin capsules daily for 6 months, providing 8 g/day of omega-3 fatty acids in ethyl ester form, including EPA 4.1 g/day and DHA 2.8 g/day.
- Key limitation
- The trial had only 6 months of follow-up and a moderate number of evaluable patients, with some dropouts and unevaluable cases.
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Open PDFOriginal abstract
BACKGROUND The omega-3 polyunsaturated fatty acids derived from fish oils have been shown to modulate many factors believed to affect the pathogenesis of atherosclerosis. Because certain features of restenosis following angioplasty mimic some of the early changes of atherogenesis, some researchers have suggested that fish oil might prevent restenosis following angioplasty. We report the effects of omega-3 fatty acids on the rate of restenosis following percutaneous intraluminal coronary angioplasty (PTCA). METHODS AND RESULTS From August 1989 through September 1992, 551 patients were randomized to start receiving a daily dietary supplement of ten 1.0-g capsules containing 80.6% ethyl esters of omega-3 fatty acids providing 4.1 g eicosapentaenoic acid (EPA) and 2.8 g docosahexaenoic acid (DHA) for 6 months or an equal amount of an ethyl ester of corn oil. Four hundred seventy subjects who were well matched for risk factors completed successful angioplasty of one or multiple lesions in native coronary vessels and constituted the study cohort, of whom 447 were evaluable at 6 months after PTCA. The criteria for restenosis were that the quantitative coronary angiography at 6 months show a > 30% increase in narrowing at the stenosis site or loss of at least half of the gain achieved at the time of PTCA and final restenosis with < 50% luminal diameter remaining. In 93% of the patients, the end point was determined by angiography and in all except 1% of these by quantitative coronary angiography. Compliance with the fish oil supplement was good as judged by incorporation of EPA and DHA in plasma and red blood cell phospholipids. The restenosis rate among analyzable patients was 46% for corn oil and 52% for fish oil (P = .37). The addition of 200 mg alpha-tocopherol for all subjects during the study had no effect on restenosis rates. CONCLUSIONS This was the largest of such trials to date, and a supplement of 8 g/d of omega-3 fatty acids failed to prevent the usual high rate of restenosis after PTCA. No adverse effects were attributable to this large daily supplement of omega-3 fatty acids.