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Armed Forces Regression Study - AFREGS
Description:
Aggressive lipid-lowering therapy for progression of coronary lesions by QCA.
Hypothesis:
Aggressive lipid-lowering therapy would decrease progression of fixed coronary lesions by QCA.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 143
Mean Follow Up: 2.5 years
Patient Populations:
Age <76 years
LDL cholesterol <160 mg/dL
HDL cholesterol <40 mg/dL after at least 8 weeks on the American Heart Association (AHA) Step-2 diet and exercise program
Measurable coronary stenosis (30% to 80%) at baseline, based on 2 independent quantitative angiographic views
Stable single- or double-vessel CHD
Exclusions:
Major vascular event within 6 months
Diabetes
Severe uncontrolled hypertension
Ejection fraction <40%
Serious complicating factors
Primary Endpoints:
Change in severity of coronary stenosis at study conclusion based on QCA; specifically, investigators measured percent stenosis of the worst lesion in each of nine proximal segments, then evaluating the proportion of patients in each group having at least one lesion progress during the course of study.
Drug/Procedures Used:
Intervention group (n=71): serial lipid assessments, plus gemfibrozil (600 mg twice daily) and, if necessary, niacin and/or cholestyramine to increase HDL by at least 25% and lower triglycerides to <100 mg/dL. Control (n=72): serial lipid assessment.
Principal Findings:
After 2.5 years, 63 of the intervention patients and 53 of the control group completed the study.
Combination therapy correlated with a significant 70% reduction in cardiac events. The intervention group experienced 3 (4.2%) cardiac events or interventions: 1 death following bypass surgery, 1 successful bypass surgery, and 1 angioplasty. The control group had a total of 10 cardiac events or interventions (13.9%), including 1 death following bypass, 6 successful bypass surgeries, and 3 angioplasty and/or stent interventions.
Compared to controls, intervention was associated with significant improvements (p=0.0001) in HDL-C (+38%) LDL-C (-24%), total cholesterol (TC) (-24%),and TG levels (-17%), and very low-density lipoprotein (VLDL) levels (48%), as well as improvements in the ratio of TC to HDL-C (+38%). The improvements were apparent at mid-study and remained at study conclusion. Throughout the 2.5 years of the study, the control group showed no significant improvement in any of these variables despite following the AHA diet and exercise program.
At baseline, there was no difference in the average angiographic stenosis for the 9 proximal segments evaluated: 33.99% for the intervention group vs. 33.71% for controls. At the end of the study, significantly fewer patients in the intervention groups showed angiographic progression compared to controls (34.72% vs 36.02%, p=0.0002). Significantly more patients in the intervention group showed no QCA change and fewer patients in this group showed progression at study end compared to controls.
There were increased co-morbidities in the intervention group, including increased abdominal pain, gastrointestinal bleeds, cholecystitis, skin rashes, and skin cancers.
Interpretation:
Low levels of high-density lipoprotein (HDL) levels are a strong independent risk factor for development of new or recurrent coronary heart disease (CHD) events (New Engl J Med 1990;322:1700-1707 Acta Med Scand 1987;221:357-62), and are often accompanied by central obesity, insulin resistance, high triglycerides (TG), hypertension, and diabetes. While the combination of low HDL-C and normal or mildly elevated low-density lipoprotein cholesterol (LDL-C) increases the risk for cardiovascular events, it is unclear whether therapies specifically designed to raise HDL-C are beneficial among these patients. Similarly, it remains unclear whether lowering triglycerides has a major impact on the angiographic or clinical course of these patients.
References:
1. Circulation 1998;98(Suppl I): I-450-1 Final results
Keywords: Obesity, Abdominal, Coronary Artery Disease, Skin Neoplasms, Gemfibrozil, Hypertriglyceridemia, Risk Factors, Constriction, Pathologic, Insulin Resistance, Angioplasty, Stents, Cholestyramine Resin, Cholesterol, Coronary Stenosis, Abdominal Pain, Cholecystitis, Niacin, Diet, Triglycerides, Hypertension, Diabetes Mellitus
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