n-3 fatty acids do not prevent restenosis after coronary angioplasty: Results from the CART study

OBJECTIVES The aim of the study was to investigate whether omega-3 fatty ac ids (n-3 FA) reduce the occurrence of restenosis after percutaneous translu minal coronary angioplasty. BACKGROUND Meta-analyses have shown significant reduction of restenosis aft er coronary angioplasty upon supplementation with n-3 FA. METHODS In a prospective, placebo-controlled, double-blind study, 500 patie nts were randomly allocated to treatment with n-3 FA (Omacor(TM), Pronova A S, Oslo, Norway) 5.1 g/day or corn oil (placebo) starting at least two week s prior to elective coronary angioplasty. The treatment was continued until restenosis evaluation by quantitative coronary angiography after six month s. Stenosis was defined as a minimal luminal diameter (MLD) <40% of the ref erence diameter. Successful coronary angioplasty was defined as greater tha n or equal to 20% acute gain in MLD and a residual stenosis <50%. Restenosi s was defined as greater than or equal to 20% late loss of diameter and ste nosis >50% or an increase in stenosis of 20.7 mm. Three-hundred ninety-two patients fulfilled the criteria for initial stenosis and successful coronar y angioplasty, and, except four patients who died, none were lost for follo w-up. RESULTS Restenosis occurred in 108/266 (40.6%) of the treated stenoses in t he Omacor group and in 93/263 (35.4%) in the placebo group (odds ratio [OR] 1.25, 95% confidence interval [CI] [0.87-1.80] p = 0.21). In the Omacor gr oup one or more restenoses occurred in 90/196 (45.9%) patients as compared with 86/192 (44.8%) in the placebo group (OR 1.05, 95% CI [0.69-1.59] p = 0 .82). CONCLUSIONS Supplementation with 5.1 g n-3 FA/day for six months, initiated at least two weeks prior to coronary angioplasty did not reduce the incide nce of restenosis. (C) 1999 by the American College of Cardiology.