Rosuvastatin reduces coronary artery disease progression over time in the ASTEROID trial

March 31, 2008 By Katherine Ogando [mailto:kogando@perfuse.org]

ACC 08-Chicago, IL: Results of the ASTEROID trial demonstrates that treatment with rosuvastatin may promote atherosclerosis regression in patients with coronary artery disease (CAD).

The study measured the effects of statin monotherapy on atherosclerosis progression. Previous studies have demonstrated a decrease in the progression of the condition through this method, but failed to stop the stenotic progression. The authors hypothesized that treatment with rosuvastatin therapy for 24 months would effect atherosclerosis regression through the reduction of low density lipoprotein cholesterol (LDL-C).

The ASTEROID (A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary Atheroma Burden) (ASTEROID) trial was an open-label, prospective, multi-centered, international study. It enrolled 507 patients aged 18 or older with angiographic evidence of coronary artery disease (CAD). The inclusion criteria consisted of at least 20% stenosis in any coronary artery, as measured angiographically, with the left main coronary artery having no more than 50% stenosis by visual estimate. The target vessel assessed through intravascular ultrasound (IVUS) could not have been treated with angioplasty or bypass surgery, and had to have less than 50% stenosis throughout a segment length of at least 40mm. There were no criteria for LDL-C levels at baseline. Patients who had used lipid lowering medication for 3 months or more for the last year, however, or who had uncontrolled diabetes (glycosylated hemoglobin levels ≥10%) or triglyceride levels (≥500 mg/dl [5.7 mmol/L]) were not allowed to participate in the study.

The 507 enrolled patients received 40 mg per day of rosuvastatin for 24 months. There were 379 angiograms that were evaluable at baseline and at the end of the study. The minimum lumen diameter (MLD) and percent diameter stenosis were evaluated for the two time points for each artery segment (up to 10 segments were evaluated), and the mean of the matched stenoses in the two time points was calculated for 292 patients with 613 matched lesions.

Rosuvastatin reduced the LDL cholesterol levels by 53.3%, down to a mean of 61.1±20.3 mg/dL. There was also a parallel increase of HDL cholesterol to 48.3±12.4 mg/dL (13.8%), p<0.001. The MLD increased from 1.65±0.36mm to 1.68±0.38mm (p<0.001). The mean percent diameter stenosis decreased from 37.3±8.4% to 36.0±10.1%.

The results suggest that rosuvastatin has a regressive effect on atherosclerosis as measured by quantitative coronary angiography (QCA) and IVUS. This study extends prior findings that show a reduction of atherosclerosis progression with statin monotherapy. This study, however, utilized two imaging methods which measured different parameters. The results are more compelling as both the QCA and IVUS demonstrated a decrease in stenoses in the patients enrolled in the ASTEROID trial.

This trial was funded by Astra-Zeneca.

Source

 * 1) Christie M. Ballantyne, Joel S. Raichlen, Stephen J. Nicholls, Raimund Erbel, Jean-Claude Tardif, Sorin J. Brener, Valerie A. Cain, Steven E. Nissen. Effect of Rosuvastatin Therapy on Coronary Artery Stenoses in the ASTEROID trial. As presented at ACC 2008.