Prevention of postcoronary angioplasty restenosis by omega-3 fatty acids: main results of the Esapent for Prevention of Restenosis ITalian Study (ESPRIT)

Abstract Background and Objective Previous trials of omega-3 fatty acids (ω-3 FA) for restenosis prevention after percutaneous transluminal coronary angioplasty (PTCA) have yielded conflicting results. We tested the hypothesis that long-term administration of ω-3 FA before PTCA may have significant effects on restenosis. Methods We randomized 339 patients in a double-blind, placebo-controlled study of ω-3 FA (as an ethyl ester preparation given as 6 1-g capsules providing 3 g eicosapentaenoic acid and 2.1 g docosahexaenoic acid/d started 1 month before PTCA and given for 1 month thereafter, then continued at half-dose for 6 months) versus an olive oil placebo. Of these, 257 patients (125 on ω-3 FA, 132 on placebo) well matched for risk factors underwent successful balloon-only PTCA (280 total lesions) and were evaluable at 6 months with repeat angiography. Restenosis was defined at quantitative angiography as a recurrence of >50% diameter stenosis in the dilated vessel (Definition I) and as >50% loss of the short-term gain immediately after PTCA (Definition II). Results Restenosis rates per vessel were 29.4% and 31.6% in the ω-3 FA group, and 39.6% and 35.4% in the placebo group according to Definitions I ( P =.04) and II ( P = not significant), respectively. Restenosis rates per patient were 31.2% and 33.6% in the ω-3 FA group, and 40.9% and 37.1% in the placebo group according to Definitions I ( P =.05) and II ( P = not significant), respectively. Conclusions With a long treatment before PTCA, ω-3 FA produced a small but significant decrease in the restenosis rate compared with placebo. (Am Heart J 2002;143:e5.)