769-3 Lipid Intervention and Progression of Coronary Atherosclerosis

Abstract

The Coronary Intervention Study, CIS, is a multicentre, randomized, doubleblind. placebo-controlled study to investigate the effects of lipid-modifying therapy on progression in 254 men with documented coronary artery disease (CAD) and hypercholesterolemia. Entry criteria were the presence of at least 3 coronary stenoses of ≥25% and a mean serum total cholesterol (C) of : ≥207 mg/dl after diet. Treatment with up to 40 mg simvastatin (S) or placebo (P) o.d. included diet and — as a reserve medication: — colestyramine, and was pursued for 2.3 years (S/P: 865/835 days). The two treatment groups (see below) were comparable with respect to baseline variables, e.g. average age (49.9/49.1 y), height(175.4/175.2 cm), weight(80.1/80 kg), blood pressure (123,5/79.8 vs. 123.1/78.6 mmHg), diastolic hypertension ≥90 mmHg (9.6/9.1%), fasting serum glucose ≥120 mg/dl (2.9/5.1%), family history (47.1/48.0%), smoking (83.6/85.9), ventricular score (1.0/0.9), coronary score (2.12/1.93 — vessel-disease), and lipid values, with a baseline LDL-C of 163.8/166.7 mg/dl. Treatment resulted in significant changes of serum lipids with a decrease of LDL-C by 33% and -1.5% in the Sand P group, respectively. 204 (81; 104/100) patients had a second angiography. Two primary end points were chosen: — the within-patient change in minimum diameter avenged over all assessable coronary segments (“ΔminD”, determined by quantitative analysis using the CAAS system), and—the visual Global Change Score (“GCS”, Blankenhorn), and calculated according to Bonferroni-Holme on a multiple significance level of 5%. The detailed results will be presented. Supported by MSD Sharp and Dohme, Munich, Germany.