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Journal of the American College of Nutrition, Vol 11, Issue 1 68-73, Copyright © 1992 by American College of Nutrition
CLINICAL TRIAL |
S. J. DeMaio, S. B. King 3rd, N. J. Lembo, G. S. Roubin, J. A. Hearn, H. N. Bhagavan and D. S. Sgoutas
Andreas Gruentzig Cardiovascular Center, Department of Internal Medicine (Cardiology), Atlanta, GA.
To test whether alpha-tocopherol prevents restenosis following percutaneous transluminal coronary angioplasty (PTCA), we enrolled patients in a double-blind, placebo-controlled trial. Patients were randomized after successful PTCA to receive vitamin E in the form of dl-alpha-tocopherol, 1200 IU/day, orally vs an inactive placebo for 4 months. Patients' blood was analyzed at baseline and at 4 months post-PTCA for differences in plasma lipids, lipoproteins, apolipoproteins, alpha-tocopherol, retinol, beta-carotene and lipoperoxide concentrations. One hundred patients completed the protocol. No significant difference was found in any parameter except alpha-tocopherol level between the vitamin E group and the placebo group, verifying compliance. Follow-up cardiac catheterization was obtained in 83% of the patients receiving placebo and in 86% of the patients receiving dl-alpha-tocopherol. Including thallium and exercise stress testing, objective information was obtained for practically all the patients receiving dl-alpha-tocopherol or placebo. Restenosis was defined as the presence of a lesion with greater than or equal to 50% stenosis in a previously dilated artery segment and results were analyzed with respect to pre- and post-PTCA artery diameter, vessel diameter at follow-up, and restenosis rate. Patients receiving dl-alpha-tocopherol had a 35.5% restenosis angiographically documented vs 47.5% restenosis in patients receiving the placebo. The overall incidence of restenosis defined by an abnormal angiogram or thallium test or exercise stress test was 34.6% in patients receiving dl-alpha-tocopherol and 50% in patients receiving the placebo. This difference (p = 0.06) did not reach significance because of an inadequate sample size.
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