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Results from Abbott's PROSPECT Study Provide New Insight into Role of Vulnerable Plaque in Coronary Artery Disease

San Francisco (ots/PRNewswire)

Abbott (NYSE: ABT) today announced primary results from its
groundbreaking PROSPECT (Providing Regional Observations to Study
Predictors of Events in the Coronary Tree) clinical trial. PROSPECT
is the first prospective natural history study to evaluate the role
of vulnerable plaque in unexpected heart attacks and the natural
progression of coronary artery disease. Results were presented today
during the late-breaking clinical trials session by Gregg W. Stone,
M.D., professor of medicine at Columbia University Medical Center,
during the 2009 Transcatheter Cardiovascular Therapeutics (TCT)
annual meeting.
"We know that certain vulnerable plaques lead to sudden cardiac
death, but until now, our understanding of how these plaques progress
has been extremely limited," said Dr. Stone, who is also immediate
past chairman of the Cardiovascular Research Foundation, New York,
and principal investigator of the PROSPECT study. "PROSPECT has
provided fundamental insights into our understanding of
atherosclerosis. Conventional wisdom has been that if we could
identify vulnerable plaques, we would be able to determine who might
be at risk for a serious cardiac event and treat them
Vulnerable plaques are inflamed, lipid-rich lesions that form in
the walls of the arteries and usually have thin, fibrous caps. The
relationship between vulnerable plaque ruptures and sudden cardiac
death is well known, but until the PROSPECT study, no systematic
effort had been made to prospectively understand the event rate
associated with progression of vulnerable plaque. Unlike hardened
plaque, vulnerable plaques are often not visible with angiography and
do not actually block blood flow in coronary arteries unless their
rupture results in a clot.
Among the findings of the 700-patient study, researchers were
able to identify the common characteristics of lesions that put
patients at highest risk for future cardiac events by using advanced
imaging called virtual histology intravascular ultrasound (VH(R)
IVUS) and standard angiography. Going forward, investigators will now
have access to more than 40,000 datapoints derived from 150 variables
within each of the patients, far beyond the level of assessment of
previous interventional studies.
"While the prognosis of patients with acute coronary syndromes
undergoing successful stenting and treated with contemporary medical
therapy is favorable, we are now able to identify those lesion types
with a significantly increased likelihood of causing future
cardiovascular events," Stone said.
The PROSPECT study recruited patients who were in need of a PCI
(percutaneous coronary intervention) to treat a heart attack or
threatened heart attack. Patients consented to collection of
additional data as follow-up to their procedure, including VH IVUS
imaging and standard angiography. PROSPECT collected data about
characteristics of vulnerable plaque lesions that were present but
not causing symptoms at the time of the procedure. The goal was to
correlate lesion characteristics, patient risk factors and biomarker
measurements with subsequent heart attacks and other cardiac events,
potentially paving the way for physicians to identify and treat
at-risk patients before a heart attack occurs.
Study Findings
In the study, approximately 20 percent of the patient population
experienced a major adverse cardiac event (cardiac death, cardiac
arrest or heart attack) within three years of enrollment. Half of
these events can be attributed to the original "culprit" lesions
(those treated with PCI) and half to previously untreated,
"non-culprit" lesions of the three-vessel coronary tree. Half of the
patients treated for non-culprit events exemplified the classic
notion of vulnerable plaque.
The event rate, particularly that attributed to vulnerable
plaques specifically, was lower than expected. Further, patients who
experienced "non-culprit" events in the years following PCI were more
likely to present with progressive or unstable angina, and rarely
with cardiac death, arrest or MI. Imaging of the lesions that did
progress to events suggests that vulnerable plaque lesions with a
large plaque burden and large necrotic core without a visible cap
were at especially high risk for future adverse cardiovascular
"Abbott's PROSPECT trial is the most comprehensive study ever
done on vulnerable plaque and the results shed new light on
understanding its role in the progression of coronary artery
disease," said John M. Capek, executive vice president, medical
devices, Abbott. "As a leader in cardiovascular devices, diagnostics
and medicines, Abbott looks forward to sharing these results with the
vascular community and adding to our understanding of the disease."
About the PROSPECT Trial
Abbott's PROSPECT trial is the first prospective natural history
study to examine the role of vulnerable plaque and how it might
progress to a cardiac event. PROSPECT used novel intravascular
imaging technology to correlate plaque characteristics, patient risk
factors and biomarker measurements with subsequent heart attacks and
other cardiac events, potentially paving the way for physicians to
identify and treat at-risk patients before a heart attack occurs.
PROSPECT enrolled 700 patients from 40 clinical centers across
the United States and Europe. All patients received PCI for acute
coronary syndrome (ACS), which included unstable angina, NSTEMI or
STEMI. Patient follow up continued for three years. Abbott sponsored
the study and VH IVUS imaging technology was provided by Volcano
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's
leading vascular care businesses. Abbott Vascular is uniquely focused
on advancing the treatment of vascular disease and improving patient
care by combining the latest medical device innovations with
world-class pharmaceuticals, investing in research and development,
and advancing medicine through training and education. Headquartered
in Northern California, Abbott Vascular offers a comprehensive
portfolio of vessel closure, endovascular and coronary products.
About Abbott
Abbott is a global, broad-based health care company devoted to
the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals, devices
and diagnostics. The company employs more than 72,000 people and
markets its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at


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