Guidant announces plans to initiate vulnerable plaque study

Guidant has announced plans to conduct a study designed to increase clinical understanding of “vulnerable” plaques – lipid-rich coronary lesions that suddenly rupture – that may cause most heart attacks.

The study will include 700 acute coronary syndrome patients receiving stents in the United States and Europe.

The study, called PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree), will utilize novel intravascular imaging technology from Volcano Therapeutics, Inc. to collect data about characteristics of lesions not causing symptoms at the time of treatment. The study will 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.

“Guidant is initiating the first prospective natural history study that will provide highly anticipated data to help further the search for evidence-based clinical assessment of patient risk,” said principal investigator Gregg W. Stone, M.D., Professor of Medicine at Columbia University Medical Center. Dr. Stone will outline the study’s design tomorrow evening in a presentation at Cardiovascular Research Foundation’s (CRF) Sixteenth Annual Scientific Symposium, Transcatheter Cardiovascular Therapeutics (TCT 2004), in Washington, D.C.

“The PROSPECT study will collect critical new information about the role of vulnerable plaque in unexpected heart attacks and about the natural progression of coronary artery disease,” said Beverly Lorell, M.D., vice president, chief medical and technology officer, Guidant Corporation. “As a growing body of scientific knowledge about vulnerable plaque is built, physicians may one day be able to better predict and prevent heart attacks.”

The cause of most heart attacks was once believed to be the gradual closing of arteries over time as plaque build-up slowly increased restricting blood and oxygen flow to the heart. However, the vast majority of heart attacks are now believed to be triggered by the rupture of a lipid-rich vulnerable plaque hidden under the surface of the artery wall, causing blood to clot on the plaque and suddenly block the artery.

For this reason, heart attacks often occur in apparently healthy people who were unaware they have this type of plaque buildup in the walls of their arteries. Treadmill “stress tests,” given to help determine whether blood supply is reduced in the arteries that supply the heart, do not indicate whether vulnerable plaque is present. Vulnerable plaques are not readily evident in angiograms either, as the hidden plaque may not yet block the vessel.

Guidant will fund the study with collaborator Volcano Therapeutics, a privately held medical device company focused on the discovery, development and commercialization of products for the detection and treatment of atherosclerosis and vulnerable plaques. Volcano Therapeutics’ technology utilizes intravascular ultrasound radio frequency signal components to characterize lesion composition and morphology.