Bezafibrate following acute myocardial infarction: important findings from the bezafibrate coronary atherosclerosis intervention trial

Abstract

Summary Objective : The study was designed to assess whether bezafibrate could retard or prevent the progression of atherosclerotic lesions in young male survivors of myocardial infarction. Design : The study was of a randomized, parallel group double-blind design. Setting : Patients were recruited into the trial from the ten hospitals in Stockholm County. Interventions : After 3 months diet, patients who fulfilled the entry criteria were randomized to treatment with bezafibrate (200 mg tid), or placebo, for 5 years. Diet was continued throughout the trial. Main outcome measures : Quantitative computer assisted coronary angiography was undertaken at baseline and after 2 and 5 years, blood lipids were assessed every 4 months, and plasma fibrinogen was monitored before treatment, at 2 and 5 years. Results : Progression as assessed by mean minimum lumen diameter (MLD) was less in the bezafibrate group then in the placebo group. The treatment effect was +0.13 mm for the primary endpoint MLD ( P = 0.049). Supportive parallel treatment effects, although not reaching statistical significance, were observed for the secondary angiographic endpoints: mean segment diameter +0.02 mm and percent stenosis −3.41%. There was a significantly lower cumulative coronary event rate amongs patientst treated with bezafibrate (3 vs. 11: P = 0.019). The angiographic effects of bezafibrate were accompanied by statistically significant treatment effects for serum cholesterol (−9%), VLDL-cholesterol (−35%), serum triglycerides (−31%), VLDL-triglycerides (−37%), and plasma fibrinogen levels (−12%). There was no net change in LDL-cholesterol and HDL-cholesterol increased significantly by 9%. Conclusions : By correcting the underlying dyslipidaemia and the haemostatic imbalance, bezafibrate is able to slow the progression of coronary atherosclerosis in a group of young post-myocardial infarction patients.