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ASTEROID Trial. A S tudy t o E valuate the Effect of R osuvastatin o n I ntravascular U ltrasound- D erived Coronary Atheroma Burden. ASTEROID Trial. ASTEROID Trial. Presented at ACC / i2 2008 in Chicago Presented by Dr. Christie M. Ballantyne.
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ASTEROID Trial AStudy to Evaluate the Effect of Rosuvastatinon Intravascular Ultrasound-Derived Coronary Atheroma Burden
ASTEROID Trial ASTEROID Trial Presented at ACC / i2 2008 in Chicago Presented by Dr. Christie M. Ballantyne Copyleft Clinical Trial Results. You Must Redistribute Slides
ASTEROID Trial: Background • Assessed the effects of rosuvastatin on atherosclerosis regression in patients who had angiographic evidence of coronary artery disease (CAD). • Prior studies have shown evidence of a decrease in atherosclerosis progression with statin therapy. • No statin monotherapy has demonstrated a cessation or regression of atherosclerosis. Presented at ACC 08
ASTEROID Trial: Study Design 507 patients > 18 years with angiographic evidence of CAD, excluding patients using lipid-lowering medication for more than 3 mos within the previous 12 mos, uncontrolled triglyceride levels, and poorly controlled diabetes. Prospective. Multicenter. International. Open Label. Treatment for 24 mos. 292 patients with 613 matched stenoses at baseline and study end. Rosuvastatin 40 mg/day n=292 24 month treatment • Primary Endpoint: Rosuvastatin regression of coronary atherosclerosis by intravascular ultrasound (IVUS) • Secondary Endpoint: Rosuvastatin regression of coronary atherosclerosis by quantitative coronary angiography (QCA). Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at ACC 08
ASTEROID Trial: Mean Diameter Stenosis p < 0.001 • The mean percent diameter stenosis decreased from 37.3±8.4% to 36±10.1% after 24 months of rosuvastatin therapy. • There was a progression of atherosclerosis in 6% of patients by >0.2mm. 37.3 ± 8.4% 36.0 ± 10.1% Mean diameter stenosis (%) n = 292 n =292 Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at ACC 08
ASTEROID Trial: Minimum Lumen Diameter p < 0.001 • The percent minimum lumen diameter (MLD) increased from 1.65 ± 0.36 mm to 1.68 ± 0.38mmafter 24 months of rosuvastatin therapy. • The MLD increased in 55.2% of patients. 1.65 ± 0.36 1.68 ± 0.38 Minimum lumen diameter(mm) n = 292 n =292 Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at ACC 08
ASTEROID Trial: LDL-C and HDL-C levels • LDL-C levels were reduced to a mean of 61.1±20.3 mg/dL (53.3% reduction) after rosuvastatin therapy. • HDL-C levels increased from 42.8 mg/dL to 48.3±12.4 mg/dL (13.8% increase) after rosuvastatin therapy. Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at ACC 08
ASTEROID Trial: Limitations • This was an observational, open-label trial, and as such, the results presented may have been affected by unidentified confounders. • The small sample size may have restricted the statistical power of the study. Presented at ACC 08
ASTEROID Trial: Summary • Treatment of rosuvastatin for 24 months was associated with atherosclerosis regression evidenced by an increase in the minimum lumen diameter and a decrease in percent diameter stenosis in patients with coronary artery disease. • Rosuvastatin also increased HDL cholesterol levels while jointly reducing LDL cholesterol levels to less than 70 mg/dL. Presented at ACC 08