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Regression growth evaluation statin study (REGRESS): study design and baseline characteristics in 600 patients. The
1Interuniversity Cardiology Institute Netherlands, Utrecht.
Insights
This study on coronary artery disease patients found low HDL cholesterol levels. Intervention choices by cardiologists were unclear, possibly influenced by angina severity.
Area of Science:
- Cardiology
- Clinical Trials
- Lipid Metabolism
Background:
- Symptomatic men with coronary artery disease (CAD) underwent diagnostic coronary arteriography.
- Significant stenosis (≥50%) in a major coronary segment was identified in the study population.
- Baseline characteristics were assessed in the Regression Growth Evaluation Statin Study (REGRESS) trial.
Purpose of the Study:
- To evaluate the effects of lipid-lowering therapy with pravastatin in men with symptomatic CAD.
- To analyze follow-up intervention strategies after coronary arteriography.
- To identify baseline cardiovascular risk factors influencing intervention decisions.
Main Methods:
- A multicentre, prospective, double-blind, randomized, placebo-controlled trial (REGRESS) was conducted.
- Baseline data from 600 normocholesterolemic patients with symptomatic CAD were analyzed.
- Follow-up interventions included angioplasty, bypass grafting, or medical management.
Main Results:
- Medical management was chosen for 44% of patients, bypass grafting for 32%, and angioplasty for 24%.
- No major cardiovascular risk factors explained the choice of follow-up intervention.
- Patients exhibited low serum high-density lipoprotein (HDL) cholesterol levels.
- Increased New York Heart Association (NYHA) classification for angina favored more aggressive interventions.
Conclusions:
- The REGRESS population had lower HDL cholesterol levels than the general Dutch population.
- The rationale for specific cardiologist-chosen interventions remains unclear.
- Angina severity appears to be a key factor in selecting more active intervention procedures.
Objective:
To assess the effects of lipid lowering, using a hydroxymethyl glutaryl coenzyme A reductase inhibitor (pravastatin) in symptomatic men with coronary artery disease. To assess follow-up intervention modes and baseline cardiovascular risk factors in men after routine diagnostic coronary arteriography which showed a significant stenosis (at least 50%) in a major segment.
Design:
Baseline characteristics are stated in a multicentre, prospective, double-blind, randomized, placebo-controlled trial entitled 'regression growth evaluation statin study' (REGRESS).
Setting:
Seven university hospitals and four referral hospitals in The Netherlands.
Patients:
The baseline characteristics are given for the initial 600 patients who entered the REGRESS trial. All patients were 'normocholesterolemic' and suffered from symptomatic coronary artery disease.
Intervention:
Initial follow-up treatment was analyzed after coronary arteriography, in accordance with standardized clinical practice (angioplasty, bypass grafting or medical management only).
Main Results:
In contrast to routine procedures, 44% of the patient population was found in the medical management only stratum, whereas 32% was found in the coronary bypass graft and 24% in the percutaneous transluminal coronary angioplasty stratum. No major coronary cardiovascular risk factor could explain the decision to perform a certain follow-up intervention. Overall patients showed a low serum high density lipoprotein (HDL) cholesterol level. A higher New York Heart Association classification for anginal complaints tended to favour a more aggressive follow-up approach.
Conclusions:
The total REGRESS population showed relatively low HDL cholesterol blood levels compared with the general Dutch population. The rationale to perform a specific follow-up intervention by the treating cardiologist is unclear. Severity of anginal complaints may lead to a more active intervention procedure.