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BEzafibrate Coronary Atherosclerosis Intervention Trial - BECAIT
Description:
The Bezafibrate Coronary Atherosclerosis Intervention Trial (BECAIT) was a double-blind, placebo-controlled intervention trial, designed to assess the feasibility of retarding or preventing the progression of atherosclerotic lesions in young male survivors of myocardial infarction (MI) by dietary intervention and administration of bezafibrate.
Hypothesis:
Treatment with bezafibrate (200 mg three times daily) would retard or prevent the progression of atherosclerotic lesions in dyslipidemic male survivors of MI who were younger than 45 years at the time of the event.
Study Design
Study Design:
Patients Screened: 278
Patients Enrolled: 81
Mean Follow Up: 2-5 years
Mean Patient Age: 45 or less
Female: 0
Patient Populations:
Dyslipidemic male survivors of MI who were younger than 45 years at the time of the event. Patients who had mean serum cholesterol of at least 5.2 mmol/l, a mean serum triglyceride of at least 1.6 mmol/l, or both on two occasions after the three-month dietary intervention were selected for coronary angiography. Those with visually detectable lesions up to 90% were randomized for the study.
Exclusions:
See inclusion criteria.
Primary Endpoints:
Change in mean minimum lumen diameter
Secondary Endpoints:
Coronary events (death, reinfarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft), serum cholesterol, HDL-C, LDL-C, triglyceride, and fibrinogen levels
Drug/Procedures Used:
A total of 92 patients completed an initial three-month period of dietary intervention and were randomly assigned to treatment with bezafibrate (200 mg three times daily) or placebo. Dietary intervention continued throughout the study. Alcohol consumption was limited, overweight patients were encouraged to lose weight, and patients were advised to stop smoking.
Coronary angiography was performed at baseline and after two and five years. A total of 81 patients (42 bezafibrate-treated and 39 placebo-treated) who underwent baseline angiography and at least one post-treatment angiogram were included in the efficacy analysis. Venous blood samples were drawn every four months for the measurement of serum cholesterol, high-density lipoprotein cholesterol (HDL-C), and triglyceride; serum apolipoproteins A-I and B and fibrinogen were also measured.
Concomitant Medications:
Cardioselective beta-blockers, low-dose aspirin, and angiotensin-converting enzyme inhibitors
Principal Findings:
The mean minimum lumen diameter decreased from baseline to the last angiographic assessment (two or five years) by 0.06 mm (95% confidence interval [CI] 0.15 reduction to 0.01 increase) in the bezafibrate group and by 0.17 mm (0.33 reduction to 0.09 increase) in the placebo group. The treatment effect was therefore 0.13 mm (95% CI 0.10-0.15, p=0.049).
The cumulative coronary event rate was significantly lower among bezafibrate-treated than among placebo-treated patients (3 vs. 11 patients, p=0.02). There were significant treatment effects of bezafibrate for serum concentrations of cholesterol (-9%, p<0.001), very-low-density lipoprotein cholesterol (VLDL-C) (-35%, p<0.001), serum triglycerides (-31%, p<0.001), and plasma fibrinogen (-12%, p=0.001), whereas LDL-C concentrations did not change. HDL-C increased significantly in the bezafibrate group (9%; p=0.02). The frequency of adverse events (except for cardiovascular events) was similar in the two groups.
Interpretation:
Among dyslipidemic young male survivors of an acute MI, treatment with bezafibrate improves dyslipidemia, lowers plasma fibrinogen, slows the progression of focal coronary atherosclerosis, and reduces coronary events.
References:
Ericsson CG, Hamsten A, Nilsson J, Grip L, Svane B, de Faire. Angiographic assessment of effects of bezafibrate on progression of coronary artery disease in young male postinfarction patients. The BECAIT Trial. Lancet 1996;347:849-53.
Keywords: Myocardial Infarction, Overweight, Lipoproteins, VLDL, Smoking, Survivors, Cholesterol, Dyslipidemias, Coronary Angiography, Hypolipidemic Agents, Bezafibrate, Fibrinogen, Confidence Intervals, Lipoproteins, HDL, Triglycerides
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