"RVX-208 lowers Inflammation and MACE Events while Regressing Atheroma
in High Risk CVD Patients"
TSX Exchange Symbol: RVX
First, the data showed statistically significant improvements in
coronary IVUS atheroma measurements and Major Adverse Cardiac Events
(MACE) in patients with a high (>2.0 mg/dL) serum high sensitivity
C-Reactive Protein (hsCRP). Serum levels of this biomarker when >2.0
mg/dL reflect a heightened state of inflammation that is a well-known
and major component of CVD risk. Patients with hsCRP>2.0 mg/dL at time
of entry into ASSURE totaled n=184 of which n=54 were given placebo
while n=130 received RVX-208. In the RVX-208 treated patients, there
was a 60% reduction (p<0.0001) in hsCRP vs. baseline and (p=0.054) vs.
placebo. Furthermore atheroma regression was observed in patients
treated with RVX-208 as measured by percent atheroma volume (PAV),
total atheroma volume (TAV) regressed, and the worst 10mm TAV segment
by -0.75% (p3 (p3 (p<0.001), respectively vs. baseline. Equally intriguing and perhaps
more important is that in RVX-208 treated patients with hsCRP>2.0 mg/dL
the incidence of MACE was lower by 63% (p=0.023) vs. placebo. The
preceding observation is of value in that hsCRP of >2.0 mg/dL is well
known to be clinically important in predicting CVD risk.
The second new observation arises from a pre-specified exploratory
endpoint in ASSURE gathered using a new catheter (Volcano Revolution
45mghz) designed for radiofrequency analysis of the IVUS signal. Data
from this catheter reveals so called virtual histology IVUS (VH-IVUS),
an emerging technology that is useful for assessing tissue
characteristics of an atherosclerotic plaque. VH-IVUS data was
analyzed to provide insight into vulnerability of an atherosclerotic
plaque to rupture and its relationship to future cardiovascular risk.
In ASSURE, while all (n=323) patients were studied using IVUS, 87 of
these were examined using the Volcano Revolution catheter to gather
VH-IVUS information. This information was used to reflect plaque
vulnerability by calculating the ratio of necrotic core to dense
calcium (NC/DC) as established by Missel et al. (Am J Cardiol 2008;
NC/DC ratio). The NC/DC ratio in RVX-208 treated patients (n=61) was
significantly lower by -7.5% (p<0.03) vs. baseline while those (n=24)
given placebo had a non-significant reduction of -3.8% (p=0.47) vs.
baseline. The initial VH-IVUS findings show that the actions of RVX-208
improved the NC/CS ratio pointing to less vulnerability of the
atherosclerotic plaque for rupture.