Prevention of postcoronary angioplasty restenosis by omega-3 fatty acids: Main results of the Esapent for Prevention of Restenosis ITalian Study (ESPRIT)  Aleardo Maresta, MDa, Marco Balduccelli, MDa, Elisabetta Varani, MDa, Mario Marzilli, MDb, Claudio Galli, MDd, Franca Heiman, DState, Maurizio Lavezzari, MDe, Eduardo Stragliotto, MDe, Raffaele De Caterina, MD, PhDb,c  American Heart Journal  Volume 143, Issue 6, Pages 1-10 (June 2002) DOI: 10.1067/mhj.2002.121805 Copyright © 2002 Mosby, Inc. Terms and Conditions

Fig. 1 ESPRIT timeline. American Heart Journal 2002 143, 1-10DOI: (10.1067/mhj.2002.121805) Copyright © 2002 Mosby, Inc. Terms and Conditions

Fig. 2 Status of patients throughout the study. Patients disqualified before PTCA (16) include mostly those whose clinical course demanded early PTCA (without the prolonged pre-PTCA administration required) or alternative treatments (coronary bypass surgery or medical treatment). A few patients discontinued treatment after earlier consent (15). Disqualification at PTCA resulted mostly from stent application at the time of PTCA (17) or unsuccessful PTCA (3). Of the 287 in whom a successful PTCA was performed, 23 were designated “unevaluable dropouts,” mostly because of loss to follow-up (7), refusal of final angiography (7), or adverse events (sudden death, 3). Of the remaining 264 patients, QCA was not possible in 7 because of angiogram quality. Final dropout rate was 10.5% of patients qualified for follow-up after PTCA and 24.2% of patients originally randomized. The 2 treatment groups remained numerically balanced throughout the selection process. American Heart Journal 2002 143, 1-10DOI: (10.1067/mhj.2002.121805) Copyright © 2002 Mosby, Inc. Terms and Conditions

Fig. 3 Cumulative frequency distribution curves of minimal lumen diameters (MLD) (ie, lumen diameter in mm at the site of maximum stenosis) at the 1-month qualifying angiogram (pre-PTCA, I, curves to the left), the immediate post-PTCA angiogram (II, curves to the right), and the exit follow-up angiogram (III, curves in the middle) in placebo (filled squares) and ω-3 fatty acid (open squares) treatment groups, by lesion. The degrees of stenosis under the 2 treatments were comparable at the pre-PTCA and immediate post-PTCA angiogram but tended to diverge at the exit follow-up angiogram. American Heart Journal 2002 143, 1-10DOI: (10.1067/mhj.2002.121805) Copyright © 2002 Mosby, Inc. Terms and Conditions

Fig. 4 Plot of relation of “late loss” (restenosis) to “acute gain” resulting from PTCA per lesion. Triangles denote lesions in the ω-3 fatty acid group, and circles denote lesions in the placebo group. The regression line of the scattergram would have a slope of 1 mm if restenosis occurred in all lesions and no slope if no restenosis occurred. The slopes for the 2 treatments are intermediate indicating some occurrence of restenosis. The slope for ω-3 fatty acids (n-3 FA) is smaller (although not significantly) than for placebo, suggesting less restenosis in the ω-3 fatty acid group. American Heart Journal 2002 143, 1-10DOI: (10.1067/mhj.2002.121805) Copyright © 2002 Mosby, Inc. Terms and Conditions

Fig. 5 Ratio of total ω-3 (α-linolenic + eicosapentaenoic + docosahexaenoic acids) to total ω-6 fatty acids (linoleic + arachidonic acids) in the active treatment and placebo groups in the various phases of the study. Asterisks denote significant differences (P <.01) from baseline at repeated analyses of variance in the ω-3 fatty acid group. The points marked by the asterisks also are significantly different (P <.05) in the comparison between the active treatment and placebo groups. American Heart Journal 2002 143, 1-10DOI: (10.1067/mhj.2002.121805) Copyright © 2002 Mosby, Inc. Terms and Conditions