CIS (Coronary Intervention Study)

18 Mar, 14

The effect of simvastatin on progression of coronary artery disease.

Purpose

To assess the effects of 40 mg/d simvastatin therapy on progression of coronary artery disease in young male patients with coronary artery disease and hyperlipidemia.

Design

Randomized, double-blind, placebo-controlled, multicenter.

254 men, aged 30-55 years, with total plasma cholesterol 207-350 mg/dL and total triglycerides <330 mg/dL, and known coronary artery disease by angiography. Patients with hypertension, diabetes, LVEF <30%, myocardial infarction within 4 weeks, PTCA within 4 months, CABG in the past, or scheduled for coronary interventions were excluded.

Follow-up

Coronary angiography at baseline and at follow-up (up to 4 years, an average of 2.3 years).

Treatment Regimen

Simvastatin 20 mg/d (n=129) or placebo (n=125). After 6 weeks if LDL cholesterol >90 mg/dL, the simvastatin dose was increased to 40 mg/d.

Additional Therapy

Lipid lowering diet. An ion-exchange resin was added after 12 weeks if LDL cholesterol was 120 mg/dL or 250 mg/dL in the simvastatin and placebo groups, respectively.

Results

Simvastatin therapy resulted in 35% reduction of LDL cholesterol compared with placebo (p=0.0001).
Coronary artery disease progressed slower in the simvastatin group. The mean global change score [visual evaluation by the method of Blankenhorn, a 7 point scale from-3 (strong regression) to + 3 (strong progression)] was-0.20-0.08 in the simvastatin and +0.58-0.10 in the placebo group (p=0.02). 34.6% of the simvastatin and 53.5% of the placebo-treated patients had progression.
Minimum lumen diameter decreased by 0.02-0.014 mm in the simvastatin vs 0.10-0.02 mm in the placebo group (p=0.002). In patients receiving simvastatin, there was significant correlation between LDL cholesterol levels during therapy and the per patient mean loss of minimum lumen diameter (r=0.29; p=0.003).
There was no difference between the groups in the incidence of serious cardiac events.

Conclusion

Simvastatin therapy, 40 mg/d for an average of 2.3 years reduced serum cholesterol and slowed the progression of coronary artery disease in young men with hypercholesterolemia and known coronary artery disease.

Eur Heart J 1997;18:226-34