Coronary Disease Clinical Trial
Official title:
A Prospective, Double-blinded, Randomised Study to Evaluate the Effects of Different Doses of Statin Treatment on Plaque Volume and Composition in Coronary Disease Determined by Virtual Histology Using Intravascular Ultrasound
While statin treatment may induce plaque regression, the effect of statin on plaque
composition with varying doses is unknown. This study assessed such effects by volumetric
virtual histology intravascular ultrasound (VH-IVUS).
In this prospective, randomized, double-blinded pilot study, statin-naïve patients with
stable angina requiring percutaneous coronary intervention (PCI) were randomized to receive
6 months of either atorvastatin 10mg or 40 mg daily. VH-IVUS was performed in all non-PCI
lesions at baseline and 6 months; all analyses were performed by core laboratory.
Statin therapy, especially at intensive doses, is beneficial in atherosclerotic coronary
disease. Detecting subtle plaque regression after statin therapy is difficult by coronary
angiogram; intravascular ultrasound (IVUS) is a far better method. Volumetric IVUS has been
used in statin trials to evaluate plaque regression. Intensive statin therapy in the
REVERSAL Trial and ASTEROID Trial appeared to achieve better regression outcomes. Stable
fibrous plaque is likely to be responsible for stable ischemia, while unstable plaque (large
lipid core, calcified nodule and necrotic core), thin-cap fibroatheroma, plaque erosion and
plaque rupture may be responsible for acute coronary syndrome (ACS). In vivo tissue
characterization of plaque composition is therefore important, yet in this regard grayscale
IVUS is insufficient. The development of Virtual Histology (VH) utilizing IVUS generated
radiofrequency backscattering signals to virtually separate plaque composition into 4
components corresponding to histopathology has made possible in vivo assessment of plaque
composition and stability. We believed plaque regression and VH-IVUS plaque modification
with statin therapy could be statin dose dependent, and may affect clinical outcomes. This
study was designed to prove our hypothesis, utilizing VH-IVUS.
This study is the first prospective, randomised, double-blinded pilot study designed to
investigate the varying statin dose effects on plaque regression and VH composition
modulation. For ethical reasons, a placebo arm was not designed. Based on available data,
clinically realistic doses of atorvastatin 10mg (low dose) and 40mg (moderate dose) were
chosen. Only statin-naïve patients without previous history of myocardial infarction (MI)
would be selected, aiming to show the "pure" effects of varying doses of statin and to
better reveal the subtle differences in the changes.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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