SAN FRANCISCO, Sept. 24 /PRNewswire-FirstCall/ -- Abbott 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.
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.
"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.
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.
"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."
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
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
