To determine the safety and benefit of n-3 fatty acid therapy in the prevention of early restenosis after coronary angioplasty, we conducted a randomized, unblinded study comparing a conventional antiplatelet regimen (325 mg of aspirin and 225 mg of dipyridamole per day; control group) with a similar regimen supplemented with 3.2 g of eicosapentaenoic acid per day (treatment group). Treatment began seven days before angioplasty and continued for six months afterward. All angiographic analyses were blinded and performed by a method that was validated by comparison with quantitative coronary angiography. In 82 male patients, 103 coronary lesions were dilated. Both groups had similar base-line clinical and angiographic characteristics. The incidence of early vessel restenosis, as determined on a second angiogram three to four months after angioplasty, was 36 percent in the control group and 16 percent in the treatment group (P = 0.026). The incidence of restenosis per patient was also significantly lower in the treatment group (46 vs. 19 percent). Both multiple logistic regression and Mantel-Haenszel statistical analyses demonstrated a significant independent benefit of treatment with n-3 fatty acids. No important bleeding complications developed in the treated patients. These results, in a male population at relatively high risk for restenosis, suggest that a dietary supplement of n-3 fatty acids, administered for one week before and for six months after coronary angioplasty, is safe and reduces the occurrence of early restenosis after that procedure. Whether this beneficial effect also applies to other populations is unknown.
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Cardiac Catheterization Laboratory, Dallas Veterans Administration Medical Center, TX 75216.
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