Aggressive versus moderate lipid-lowering therapy in postmenopausal women with hypercholesterolemia: Rationale and design of the Beyond Endorsed Lipid Lowering with EBT Scanning (BELLES) trial

Background Electron beam tomography (EBT) is a noninvasive technique that a llows the study of the entire coronary artery tree during a brief imaging s ession without the injection of any contrast media. Atherosclerosis is iden tified vicariously through the visualization of coronary calcific deposits. Quantitative assessments of calcium burden, such as calcium volume scores, have been shown to be a useful means to assess treatment-related changes i n the extent of atherosclerotic plaques. Historically, the elderly female p opulation has received less medical recognition regarding the risk and seve rity of coronary heart disease (CHD). Methods In the BELLES (Beyond Endorsed lipid Lowering with EBT Scanning) tr ial, the presence of asymptomatic CHD in 600 postmenopausal women will be a ssessed by EBT. In this 1-year, multicenter, randomized, double-blind, para llel-group study, aggressive lipid-lowering treatment will be compared with moderate lipid-lowering treatment in postmenopausal women with hypercholes terolemia. The hypothesis we will test is that aggressive lipid-lowering th erapy with 80 mg/d atorvastatin can produce greater reductions in atheroscl erotic plaque burden as assessed by volumetric calcium stores than a modera te treatment with 40 mg/d pravastatin. The primary outcome measure will be the percent change from baseline in fetal CVS determined by EBT at 12 month s. Conclusions The results of the BELLES trial will help assess the actual inc idence of CHD in postmenopausal women and the relative ability of two diffe rent lipid-lowering therapies to halt its progression.