The Lipoprotein and Coronary Atherosclerosis Study (LCAS): Design, methods, and baseline data of a trial of fluvastatin in patients without severe hypercholesterolemia

Few direct clinical data are available regarding whether cholesterol-lowering therapy should be extended to patients with coronary heart disease (CHD) and normal or only slightly elevated plasma cholesterol concentrations. The one published angiographic trial designed to examine this question found...

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Bibliographic Details
Published in:	Controlled clinical trials Vol. 17; no. 6; pp. 550 - 583
Main Authors:	Stewart West, M., Alan Herd, J, M.Ballantyne, Christie, J. Pownall, Henry, Simpson, Suzanne, Lance Gould, K., M. Gotto, Antonio
Format:	Journal Article
Language:	English
Published:	New York, NY Elsevier Inc 01-12-1996 Elsevier Science
Subjects:	Adult Aged angiography Anticholesteremic Agents - therapeutic use atherosclerosis Biological and medical sciences Blood Coagulation Factors - metabolism cholesterol Coronary Angiography Coronary Artery Disease - blood Coronary Artery Disease - drug therapy Coronary Artery Disease - pathology Coronary disease Double-Blind Method emission-computed Fatty Acids, Monounsaturated - therapeutic use Female General and cellular metabolism. Vitamins Humans hydroxymethylglutaryl coenzyme A reductases/antagonists and inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypercholesterolemia - drug therapy Indoles - therapeutic use Lipids - blood Male Medical sciences Middle Aged Multicenter Studies as Topic Multivariate Analysis Patient Selection Pharmacology. Drug treatments Prospective Studies Random Allocation Randomized Controlled Trials as Topic - methods Regression Analysis Research Design Severity of Illness Index tomography Tomography, Emission-Computed atherosclerosis emission-computed tomography cholesterol hydroxymethylglutaryl coenzyme A reductases/antagonists and inhibitors Coronary disease angiography Human Angiography Enzyme Treatment efficiency Enzyme inhibitor Cardiovascular disease Exploration Coronary heart disease Cholesterol Vascular disease Chemotherapy Randomization Fluvastatin Investigation method Atherosclerosis Double blind study Hydroxymethylglutaryl-CoA reductase Oxidoreductases Antilipemic agent Emission tomography
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Summary:	Few direct clinical data are available regarding whether cholesterol-lowering therapy should be extended to patients with coronary heart disease (CHD) and normal or only slightly elevated plasma cholesterol concentrations. The one published angiographic trial designed to examine this question found no benefit. Additional prospective data will be provided by the Lipoprotein and Coronary Atherosclerosis Study (LCAS), a randomized, double-blind, placebo-controlled trial of fluvastatin therapy (20 mg twice daily) monitored by both quantitative coronary angiography (QCA) and, in a subset of patients, positron-emission tomography (PET). Eligible subjects in LCAS were men and women 35–75 years of age with low-density lipoprotein (LDL) cholesterol of 115–190 mg/dL on stable dietary therapy and with angiographic evidence by caliper measurement of at least one coronary atherosclerotic lesion causing 30–75% diameter stenosis. Among the 429 patients randomized (mean age 58.8, 81% male), mean baseline LDL cholesterol was only 145.6 mg/dL. Any patient with mean prerandomization LDL cholesterol of 160 mg/dL or higher also received open-label adjunctive cholestyramine. The primary endpoint is within-patient per-lesion change in minimum lumen diameter (MLD) as measured by QCA at baseline and 2.5-year follow-up. All evaluable lesions had MLD at least 0.8 mm less than the reference lumen diameter at either baseline or follow-up and MLD at least 25% of the reference lumen diameter at baseline. Data obtained on myocardial perfusion changes (99 patients underwent initial PET), special lipid particles, and coagulation factors may help define which patients with CHD and relatively low LDL cholesterol will benefit from lipid-lowering treatment.
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ISSN:	0197-2456 1879-050X
DOI:	10.1016/S0197-2456(96)00178-X