Atorvastatin 80 mg daily significantly reduced 3D carotid plaque volume compared to placebo over 3 months (-90.25 mm3 vs 16.81 mm3; P<0.0001).
RCT (n=38)
Double-blind
randomly assigned
Does atorvastatin 80 mg daily reduce carotid plaque volume measured by 3D ultrasound in patients with carotid stenosis >60%?
3D ultrasound measurement of carotid plaque volume can detect significant antiatherosclerotic effects of high-dose statin therapy in just 3 months with small sample sizes.
Absolute Event Rate: -90.25% vs 16.81%
p-value: p=<0.0001
BACKGROUND AND PURPOSE: New therapies are being developed that are antiatherosclerotic but that lack intermediate end points, such as changes in plasma lipids, which can be measured to test efficacy. To study such treatments, it will be necessary to directly measure changes in atherosclerosis. The study was designed to determine sample sizes needed to detect effects of treatment using 3D ultrasound (US) measurement of carotid plaque. METHODS: In 38 patients with carotid stenosis >60%, age+/-SD 69.42+/-7.87 years, 15 female, randomly assigned in a double-blind fashion to 80 mg atorvastatin daily (n=17) versus placebo (n=21), we measured 3D plaque volume at baseline and after 3 months by disc segmentation of voxels representing carotid artery plaque, after 3D reconstruction of parallel transverse duplex US scans into volumetric 3D data sets. RESULTS: There were no significant differences in baseline risk factors. The rate of progression was 16.81+/-74.10 mm3 in patients taking placebo versus regression of -90.25+/-85.12 mm3 in patients taking atorvastatin (P<0.0001). CONCLUSIONS: 3D plaque volume measurement can show large effects of therapy on atherosclerosis in 3 months in sample sizes of approximately 20 patients per group. Sample sizes of 22 per group would be sufficient to show an effect size of 25% that of atorvastatin in 6 months. This technology promises to be very useful in evaluation of new therapies.
Ainsworth et al. (2005) conducted an RCT in carotid stenosis >60% (n=38). atorvastatin vs. placebo was evaluated on change in 3D plaque volume (p=<0.0001). Atorvastatin 80 mg daily significantly reduced 3D carotid plaque volume compared to placebo over 3 months (-90.25 mm3 vs 16.81 mm3; P<0.0001).