Abstract 4534: Virtual Histology Findings of the Effects of Atorvastatin Treatment on Coronary Plaque Volume and Composition (The VENUS Study)
Background: The VENUS study is a randomized double blinded pilot study designed to evaluate the effect of different doses of atorvastatin on the changes of plaque volume & composition, as assessed by Virtual Histology (VH) at 6 months interval, in statin-naïve patients requiring PCI. The primary end-point is the VH changes at 6 months. The interim results of all the subjects already received re-study to date are reported, without un-blinding the 2 groups.
Methods: 40 statin-naïve patients (20 on each arm; atorvastatin 10 vs. 40mg/d, randomized, double blinded) with stable ischemia requiring PCI were enrolled and had VH study at baseline; 30 of them had 6 months re-study to date. Atorvastatin were taken continuously for 6 months until re-study. Plaques were quantified into fibrous, fibrofatty, necrotic core and calcium components by VH. Only plaques not requiring treatment by PCI & ≥5mm distance from any PCI segments, lumen CSA ≥4mm2 and plaque burden ≥20% by IVUS were included. Extremely calcified lesions precluding accurate VH analysis were excluded. VH findings of directly matched plaque segments at baseline and at 6 months were compared by core lab. Analysis was by 2-sample t-test.
Results: 41 arteries (9 LAD, 12 LCX and 20 RCA), with 92 non-intervened lesions (mean length 12.1±8.4mm) were analyzed.
Conclusions: This interim analysis shows for the first time atorvastatin at conventional doses (10 – 40mg/d) for 6 months is able to very significantly modify the plaque volume & VH components (reduction in both plaque volume and all VH components as tabled, except a relative increase in the necrotic core percentage, due to reduction of other VH component percentages) and a slight increase in calcium.