Press Release
Results from Abbott's PROSPECT Study Provide New Insight into Role of Vulnerable Plaque in Coronary Artery Disease
September 24, 2009
San Francisco — 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 prophylactically."
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® 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 events.
"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 Corporation.
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 (NYSE: ABT)
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.
Media:
Tracy Sorrentino
Jennie Kim |
(847) 937-8712
(408) 845-1755 |
Financial:
Tina Ventura |
(847) 935-9390 |
