Usefulness of fish oil supplements in preventing clinical evidence of restenosis after percutaneous transluminal coronary angioplasty.
This study assesses the effect of dietary supplements with high dose omega-3 fatty acid (N3FA) on the frequency of clinical restenosis during the 6 months after successful percutaneous transluminal coronary angioplasty (PTCA). One hundred ninety-four patients (214 significant coronary narrowings) were randomized after successful PTCA to receive conventional medical therapy or to an identical regimen supplemented by high dose N3FA (4.5 g/day). Enrollment required angina pectoris and successful dilatation of all significant coronary narrowings. The subjects were randomly assigned to either no N3FA (control, n = 99) or N3FA supplementation (n = 95). After a 1-week trial period, 11 (group 2) declined further treatment because of side effects. The remaining 84 subjects (group 1) continued N3FA throughout the 6-month period. Monthly clinical follow-up was obtained in all patients. Ninety-two percent of patients had cardiac testing for evaluation of recurrent ischemia. Except for a greater percentage of women in the group refusing N3FA supplementation (group 2), the 3 groups were similar in demographic data, medical history, dietary habits, history of previous PTCA and angiographic characteristics. Of the 194 subjects, 56 had clinical restenosis (45 by cardiac catheterization, 8 by exercise testing and 3 by symptoms alone [refused further clinical testing]). Reocclusion rates were: group 1 19%, group 2 46%, and control 35%. Analysis both in accordance with the principle of intention to treat and for subjects who actually received N3FA revealed a significant effect of N3FA on preventing clinical restenosis (p less than 0.04 and p = 0.008, respectively). These data suggest that high dose N3FA supplements reduce the clinical restenosis rate after successful PTCA.
Milner
M R
MR
Department of Medicine, Washington Hospital Center, Washington, DC 20010.
Gallino
R A
RA
Leffingwell
A
A
Pichard
A D
AD
Brooks-Robinson
S
S
Rosenberg
J
J
Little
T
T
Lindsay
J
J
D000792:Angiography; D000800:Angioplasty, Balloon; D002986:Clinical Trials as Topic; D003251:Constriction, Pathologic / Q000628:therapy; D017023:Coronary Angiography; D003327:Coronary Disease / Q000628:therapy*; D005231:Fatty Acids, Unsaturated / Q000627:therapeutic use*; D005260:Female; D005395:Fish Oils / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D012008:Recurrence
D005231:Fatty Acids, Unsaturated; D005395:Fish Oils