Prevention of postcoronary angioplasty restenosis by omega-3 fatty acids: main results of the Esapent for Prevention of Restenosis ITalian Study (ESPRIT).
OBJECTIVE
Previous trials of omega-3 fatty acids (omega-3 FA) for restenosis prevention after percutaneous transluminal coronary angioplasty (PTCA) have yielded conflicting results. We tested the hypothesis that long-term administration of omega-3 FA before PTCA may have significant effects on restenosis.


METHODS
We randomized 339 patients in a double-blind, placebo-controlled study of omega-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 omega-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 omega-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 omega-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, omega-3 FA produced a small but significant decrease in the restenosis rate compared with placebo.
Maresta
Aleardo
A
Department of Cardiology, Ospedale S. Maria delle Croci, Ravenna, Italy.
Balduccelli
Marco
M
Varani
Elisabetta
E
Marzilli
Mario
M
Galli
Claudio
C
Heiman
Franca
F
Lavezzari
Maurizio
M
Stragliotto
Eduardo
E
De Caterina
Raffaele
R
D015906:Angioplasty, Balloon, Coronary; D023903:Coronary Restenosis / Q000517:prevention & control*; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069463:Olive Oil; D010349:Patient Compliance; D010938:Plant Oils / Q000627:therapeutic use
D015525:Fatty Acids, Omega-3; D000069463:Olive Oil; D010938:Plant Oils