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The Monitored Atherosclerosis Regression Study (MARS). Design, methods and baseline results
L Cashin-Hemphill1, D M Kramsch, S P Azen
1Atherosclerosis Research Institute, University of Southern California School of Medicine, Los Angeles 90033.
Insights
The Monitored Atherosclerosis Regression Study (MARS) evaluated lovastatin
Area of Science:
- Cardiology
- Pharmacology
- Medical Research
Background:
- Atherosclerosis is a significant contributor to coronary artery disease.
- Statins, such as HMG-CoA reductase inhibitors, are widely used for cholesterol lowering.
- The Monitored Atherosclerosis Regression Study (MARS) was initiated to investigate the impact of statin monotherapy on atherosclerosis progression.
Purpose of the Study:
- To evaluate the effect of cholesterol lowering by monotherapy with an HMG-CoA reductase inhibitor on atherosclerosis progression and regression.
- To present the design, methods, and baseline results of the MARS trial.
Main Methods:
- A prospective, randomized, double-blind, placebo-controlled trial.
- 270 participants with angiographically documented coronary artery disease received either lovastatin (40 mg b.i.d.) or placebo, alongside a low-fat, low-cholesterol diet.
- Primary endpoint: average change in percent diameter stenosis (%S) by quantitative coronary angiography (QCA); secondary endpoints included categorical progression and minimum lumen diameter (MLD) changes.
Main Results:
- Baseline characteristics of the 270 participants (91.5% male, mean age 57.9 years) were comparable between lovastatin and placebo groups.
- Mean baseline lipid levels included Total Cholesterol (TC) 231 mg/dL, LDL-C 157 mg/dL, HDL-C 43 mg/dL, and triglycerides 160 mg/dL.
- No significant differences in baseline lipid levels or angiographic characteristics were observed between the treatment groups.
Conclusions:
- The baseline data from MARS confirm successful randomization.
- The lovastatin and placebo groups demonstrated comparability in demographic, lipid, and angiographic profiles.
- This comparability supports the validity of the study's design for evaluating the efficacy of lovastatin in atherosclerosis.
Objective:
The Monitored Atherosclerosis Regression Study (MARS) was designed to evaluate the effect of cholesterol lowering by monotherapy with an HMG-CoA reductase inhibitor on progression/regression of atherosclerosis in subjects with angiographically documented coronary artery disease. The purpose of this paper is to present the design, methods, and baseline results of MARS.
Design:
MARS is a prospective, randomized, double-blind, placebo-controlled trial with baseline, 2-year, and 4-year coronary angiography as well as carotid, brachial, and popliteal ultrasonography.
Setting:
Outpatient clinics at the University of Southern California School of Medicine and the University of Wisconsin School of Medicine.
Subjects:
Two hundred seventy participants of both sexes were recruited directly from the cardiac catheterization laboratory or by chart review of patients having undergone cardiac catheterization in the past. Subjects were considered eligible if they had angiographically demonstrable atherosclerosis in 2 or more coronary artery segments, unaltered by angioplasty, with at least 1 lesion > or = 50% but < 100% diameter stenosis (%S). The inclusion range for total cholesterol (TC) was between 190 and 295 mg/dL. Exclusion factors were: triglycerides > or = 500 mg/dL; premenopausal females; uncontrolled hypertension; diabetes mellitus; untreated thyroid disease; liver dysfunction; renal insufficiency; congestive heart failure; major arrhythmia; left ventricular conduction defects; or any life-threatening disease.
Intervention:
Subjects were placed on a low-fat, low-cholesterol diet and either 40 mg b.i.d. lovastatin (Mevacor) or placebo. Randomization was stratified by sex, smoking status, and TC.
Main Outcome Measures:
Per-subject average change in %S as determined by quantitative coronary angiography (QCA) is the primary angiographic endpoint. Secondary endpoints are: categorical analyses of the proportion of subjects with progression; human panel reading of coronary angiograms; and change in minimum lumen diameter (MLD) in mm by QCA. Carotid, brachial, and popliteal ultrasonography is also being performed.
Results:
The subjects randomized into MARS are 91.5% male with an age range of 37 to 67 years (mean age 57.9 years). For the cohort, baseline lipids are (mean +/- SD): TC, 231 +/- 24 mg/dL; low-density lipoprotein cholesterol (LDL-C) by ultracentrifugation, 153 +/- 24 mg/dL; LDL-C, by calculation, 157 +/- 23 mg/dL; high-density lipoprotein cholesterol (HDL-C), 43 +/- 10 mg/dL; and triglycerides, 160 +/- 73 mg/dL. There were no significant differences between treatment groups in baseline lipid levels or baseline angiographic characteristics.
Conclusions:
MARS baseline data show adequacy of randomization with comparability of lovastatin and placebo groups in demographic, lipid, and angiographic characteristics.
