St. Thomas Atherosclerosis Regression Study - STARS-Atherosclerosis

Description:

Lipid-lowering therapy for angiographic progression and mortality in CAD.

Hypothesis:

Reduction of plasma cholesterol concentrations using either a lipid-lowering diet, or a lipid-lowering diet plus lipid-lowering drugs would retard the progression and increase the regression of coronary artery disease.

Study Design

Study Design:

Patients Screened: Not giveen
Patients Enrolled: 90
Mean Follow Up: 39 months
Mean Patient Age: Controls: 53.9 years Diet only: 48.9 years Diet pl
Female: 0

Patient Populations:

Men referred for coronary angiography to investigate angina pectoris or other findings suggestive of CHD
Under 66 years of age
Plasma cholesterol concentrations above 6.0 mmol/L in two consecutive blood samples while on their usual diet

Exclusions:

Plasma cholesterol concentrations above 1.0 mmol/L
Patients already treated with lipid-lowering drugs
Fasting plasma triglyceride concentrations above 4 mmol/L
Remnant hyperlipidemia
Fasting glucose above 7 mmol/L
Cardiac failure
Myocardial infarction in the previous 8 weeks
Malignancy or other major organ disease
Accelerated hypertension
Initial angiographic or clinical findings indicating a need for coronary artery revascularization, or recent receipt of coronary artery revascularization

Primary Endpoints:

Change in mean absolute width of the coronary segment (MAWS).

Secondary Endpoints:

Death (by any cause)
Non-fatal myocardial infarction
Coronary artery bypass surgery or angioplasty during the trial
Stroke
Frequency and degree of angina
Change in antianginal medication

Drug/Procedures Used:

Diet-plus-cholestyramine group also received 8 g cholestyramine bid with meals.

Diet and diet-plus-cholestyramine groups received lipid-lowering diet, consisting of:
total fat intake: 27% of total energy
saturated fatty acid content: 8-1

Concomitant Medications:

β-blockers (35%)
Calcium agonists (34%)
Long-acting oral nitrates (24%)
Diuretics (19%)
Aspirin (18%)
Dipyridamole (13%)

Principal Findings:

MAWS of coronary segments increased by 0.003 mm in diet-only group, and by 0.103 mm in diet-plus-cholestyramine group, compared with decrease in controls.

Change in MAWS was independently and significantly correlated with LDL cholesterol concentration and LDL/HDL ratio during the trial period.

Dietary intervention alone and with cholestyramine significantly reduced the frequency of cardiovascular events.

Dietary change alone retarded overall progression and increased overall regression of coronary artery disease.

Interpretation:

The findings support the use of a lipid-lowering diet and if necessary, of appropriate drug treatment in men with CHD who have even mildly raised serum cholesterol levels.

References:

1. Lancet 1992;339:563-9. Final results

Clinical Topics: Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Lipid Metabolism, Nonstatins, Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Nuclear Imaging, Diet

Keywords: Cholestyramine Resin, Coronary Artery Disease, Food Habits, Cholesterol, LDL, Coronary Angiography, Fatty Acids, Diet


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