Randomized, controlled trial of secondary prevention of coronary sclerosis in normocholesterolemic patients using pravastatin: final 5-year angiographic follow-up of the Prevention of Coronary Sclerosis (PCS) study

Background: The potential benefit of cholesterol-lowering therapy for normocholesterolemic patients with coronary artery disease (CAD) has not been clarified. The Prevention of Coronary Sclerosis (PCS) Study was designed to evaluate the effect of pravastatin on secondary prevention of progression of CAD in normocholesterolemic patients for a period of 5 years. Methods: A total of 329 patients with CAD were enrolled. Normocholesterolemic patients were defined by a serum total cholesterol (TC) level of 180–219 mg/dl. Patients in this group were randomized into pravastatin and dietary control groups. Patients whose serum TC level fell outside the normal range were divided into a high-cholesterol reference group (TC≥220 mg/dl) and a low-cholesterol reference group (TC<180 mg/dl). Patients in the pravastatin and high-cholesterol groups received pravastatin 10 mg/day. Coronary angiography was performed at baseline, 2 years, and 5 years and analyzed by quantitative coronary arteriography. Angiographic coronary progression was evaluated by minimum obstruction diameter (MOD) and mean segment diameter (MSD). Results: At 5 years, change in MOD was significantly (change, P=0.033; change/years, P=0.032) less in the pravastatin group (−0.04±0.17 mm) than in the dietary control group (−0.16±0.27 mm). Although a similar trend was observed in the MSD results, the differences were not significant. Conclusion: Long-term angiographic data show that cholesterol-lowering therapy by pravastatin prevents progression of coronary atherosclerosis in normocholesterolemic patients with CAD.