Clinical Studies
B-Mode Ultrasound Assessment of Pravastatin Treatment Effect on Carotid and Femoral Artery Walls and Its Correlations With Coronary Arteriographic Findings: A Report of the Regression Growth Evaluation Statin Study (REGRESS)

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Abstract

Objectives. In this B-mode ultrasound study we assessed pravastatin treatment effects on carotid and femoral artery walls and investigated the correlations between the state and evolution of peripheral and coronary atherosclerosis.

Background. The Regression Growth Evaluation Statin Study (REGRESS) was an 11-center, 2-year, double-blind, placebo-controlled, prospective study of 885 men with coronary artery disease (CAD) (total cholesterol 4 to 8 mmol/liter). The study primarily investigated pravastatin treatment effects on the coronary lumen. This report focuses on the 255 patients who participated in the REGRESS ultrasound study.

Methods. Carotid and femoral artery walls were imaged at baseline and at 6, 12, 18 and 24 months. Pravastatin treatment effect was defined as the difference in progression of the combined intima-media thicknesses (IMT) between treatment groups.

Results. Pravastatin treatment effects were highly significant (combined IMT: p = 0.0085; combined far wall IMT: p < 0.0001; common femoral artery far wall IMT: p = 0.004). Correlations between the IMTs of the arterial wall segments ranged from −0.17 to 0.81. Baseline correlations between IMT and percent coronary lumen stenoses ranged from 0.23 to 0.36. Baseline IMT correlated with the mean coronary segment diameter (r = −0.32, p = 0.001) and minimal coronary obstruction diameter (r = −0.27, p = 0.005). There were no individual correlations between IMT and coronary lumen variables (p > 0.30).

Conclusions. Pravastatin treatment effects on carotid and femoral artery walls were observed. B-mode ultrasound imaging studies of peripheral arterial walls could not describe the state and evolution of the coronary lumen in the individual patient, but proved to be a highly suitable tool for the assessment of antiatherosclerotic properties of agents.

Abbreviations

CAD
coronary artery disease
CCA
common carotid artery
CFA
common femoral artery
CI
confidence interval
IMT
intima-media thickness
QCA
quantitative coronary arteriography
MOD
minimal (coronary) obstruction diameter
MSD
mean (coronary) segment diameter
REGRESS
Regression Growth Evaluation Statin Study
SFA
superficial femoral artery

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The REGRESS trial was sponsored by Bristol-Myers Squibb Company, Princeton, New Jersey.

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A complete list of REGRESS participants appears in reference .