FISH OILS AND LOW-MOLECULAR-WEIGHT HEPARIN FOR THE REDUCTION OF RESTENOSIS AFTER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY - THE EMPARSTUDY

Background Percutaneous transluminal coronary angioplasty (PTCA) is co mplicated by restenosis within 6 months in >40% of patients. Theoretic al, animal experimental, and human epidemiological and clinical trial findings have suggested that fish oils (n-3) might reduce restenosis. Low-molecular-weight heparin (LMWH) has reduced cellular proliferation and restenosis in several experimental systems. Methods and Results W e randomized 814 patients to fish oils (5.4 g n-3 fatty acids) or plac ebo a median of 6 days before PTCA and continued for 18 weeks. At the time of sheath removal, 653 patients with at least one successfully di lated lesion were randomized to LMWH (30 mg SC BID) or control for 6 w eeks in a 2 x 2 factorial design. Follow-up with quantitative coronary angiography (QCA; target, 18 weeks) was interpretable on 96% of these patients. Restenosis rates per patient were for n-3, 46.5%; placebo, 44.7%; LMWH, 45.8%; and control, 45.4%. Restenosis rates per lesion we re for n-3, 39.7%; placebo, 38.7%; LMWH, 38%; and control, 40.4%. At f ollow-up QCA, mean minimal lumen diameters were (mm) for n-3, 1.12; pl acebo, 1.10; LMWH, 1.12; and control, 1.10. Fifteen percent of patient s permanently discontinued n-3/placebo before study completion, and 21 % of patients discontinued LMWH early. There were no significant diffe rences in the occurrences of ischemic events. Bleeding was more common with LMWH, usually was mild, and led to early discontinuation of stud y medication in only 0.9% of patients. Gastrointestinal side effects w ere more common in patients receiving n-3 than placebo. Conclusions Th ere is no evidence for a clinically important reduction of PTCA resten osis in this trial by either n-3 or LMWH. Evaluation of the results fo r n-3 in the context of previously published data on the reduction of PTCA restenosis indicates that n-3 is not efficacious and that further trials are unwarranted.