Angiographic Intervention Trial Using Hmg Coa Reductase Inhibitor to Evaluate Retardation of Obstructive Multiple Atheroma in West Japan (ATHEROMA Study): Rationale,Design and Baseline

Abstract

The ATHEROMA study is a prospective, multicentre, randomized controlled study in Japan to assess the changes of coronary atherosclerosis of patients with pre-existing coronary artery disease (CAD) by cholesterol-lowering therapy (CLT) using pravastatin 10–20mg per day for 3 years. The primary objective is to evaluate the changes in coronary minimum lumen diameters by quantitative coronary arteriography, and the secondary outcome is to observe morphological changes of plaques and clinical events including mortality, recurrence of CAD and the requirement of any coronary intervention. The primary objective will test the hypothesis that CLT results in a beneficial effect on coronary vessels in patients with coronary atherosclerosis in Japan, where the incidence of CAD is the lowest among industrialized countries. A total of 373 eligible patients were recruited from 799 patients and allocated to a dietary (n=187) and pravastatin regimen (n=186) by the minimization method. Clinical characteristics in the two groups were well matched and there were no differences in serum lipids and coronary status between them. The average ± SD (range) of total, LDL and HDL cholesterol were 225.6 ± 17.3 mg/dl, 141.9 ± 21.2 mg/dl and 49.4 ± 12.0 mg/dl, respectively. Three years of follow-up were completed in late 2000, and cine angiograms blinded through the study coordinating centre were interpreted at the angiographic core laboratory. The final results, which are due to be published in 2002, will reveal whether or not specifically designed prophylactic strategy based on different cultural background is required.