Title

Effect of simvastatin on coronary atheroma: The Multicentre Anti-Atheroma Study (MAAS) .

Purpose

To evaluate the effects of simvastatin on coronary atheroma in patients with moderate hypercholesterolemia and coronary artery disease.

Design

Randomized, double blind, placebo controlled, multicenter.

Patients

381 patients, age 30-67 years, with documented coronary artery disease, serum cholesterol 5.5-8.0 mmol/l and triglyceride < 4.0 mmol/l were included. Patients with unstable angina or myocardial infarction within 6 weeks, angioplasty or surgery within 3 months, treated diabetes mellitus, or patients with congestive heart failure or ejection fraction <30%were excluded.

Follow-up

Clinical follow-up for 4 years. Coronary angiography before therapy was started and after 2 and 4 years.

Treatment regimen

Simvastatin 20 mg/d or placebo

Additional therapy

Lipid lowering diet

Results

• Patients receiving simvastatin had 23% reduction of serum cholesterol, 31% reduction of LDL cholesterol, and a 9% increase in HDL cholesterol compared with placebo after 4 years.
• Mean luminal diameter was reduced by 0.08 ± 0.26 mm vs. 0.02 ± 0.23 mm in the placebo and simvastatin groups (treatment effect 0.06), and minimal luminal diameter was reduced by 0.13 ± 0.27 mm vs 0.04 ± 0.25 mm (treatment effect 0.08) (combined p = 0.006).
• Diameter stenosis was increased by 3.6 ± 9.0% vs. 1.0 ± 7.9%, respectively (treatment effect -2.6%).
• The beneficial effect of simvastatin was observed regardless of the initial diameter stenosis.
• Angiographic progression occurred in 32.3% vs. 23.0% of the placebo and simvastatin groups, and regression in 12.0% vs 18.6%, respectively (combined p=0.02).
• New lesions developed in 3.7% vs. 2.0% of the segments studied, respectively. More patients in the placebo than simvastatin group (34 vs. 23 patients) underwent coronary revascularization.

Conclusion

Simvastatin 20 mg/d reduced hyperlipidemia and slowed the progression of diffuse and focal coronary artery disease.