The lipoprotein and coronary atherosclerosis study (LCAS): Design, methods, and baseline data of a trial of fluvastatin in patients without severe hypercholesterolemia

M. Stewart West, J. Alan Herd, Christie M. Ballantyne, Henry J. Pownall, Suzanne Simpson, K. Lance Gould, Antonio M. Gotto

Research output: Contribution to journalArticle

31 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)550-583
Number of pages34
JournalControlled Clinical Trials
Volume17
Issue number6
DOIs
StatePublished - 1996

Keywords

  • Angiography
  • Atherosclerosis
  • Cholesterol; hydroxymethylglutaryl coenzyme A reductases/antagonists and inhibitors
  • Coronary disease
  • Emission-computed
  • Tomography

ASJC Scopus subject areas

  • Pharmacology

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