Results from the PROSPECT clinical trial shed new light on the types of vulnerable plaque that are most likely to cause sudden, unexpected adverse cardiac events, and on the ability to identify them through imaging techniques before they occur.
The trial, Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT), is the first prospective natural history study of atherosclerosis using multi-modality imaging to characterize the coronary tree. The study findings were published in the January 20, 2011 issue of the New England Journal of Medicine.
"As a result of the PROSPECT trial, we are closer to being able to predict -- and therefore prevent -- sudden, unexpected adverse cardiac events," said principal investigator Gregg W. Stone, MD. Dr. Stone is Professor of Medicine at Columbia University College of Physicians and Surgeons, Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center and Co-Director of the Medical Research and Education Division at the Cardiovascular Research Foundation (CRF).
The multi-center trial studied 700 patients with acute coronary syndromes (ACS) using three-vessel multimodality intra-coronary imaging -- angiography, grayscale intravascular ultrasound (IVUS), and radiofrequency IVUS -- to quantify the clinical event rate due to atherosclerotic progression and to identify those lesions that place patients at risk for unexpected adverse cardiovascular events (sudden death, cardiac arrest, heart attacks and unstable or progressive angina).
Among the discoveries of the trial are that most untreated plaques that cause unexpected heart attacks are not mild lesions, as previously thought, but actually have a large plaque burden and/or a small lumen area. These are characteristics that were invisible to the coronary angiogram but easily identifiable by grayscale IVUS.
Moreover, and perhaps most importantly, for the first time it was demonstrated that characterization of the underlying plaque composition (with radiofrequency IVUS, also known as VH-IVUS) was able to significantly improve the ability to predict future adverse events beyond other more standard imaging techniques.
"These results mean that using a combination of imaging modalities, including IVUS to identify lesions with a large plaque burden and/or small lumen area, and VH-IVUS to identify a large necrotic core without a visible cap (a thin cap fibroatheroma) identifies the lesions that are at especially high risk of causing future adverse cardiovascular events," Dr. Stone said.
Results of the trial were first reported at the 2009 Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium, sponsored by CRF.
- Gregg W. Stone, Akiko Maehara, Alexandra J. Lansky, Bernard de Bruyne, Ecaterina Cristea, Gary S. Mintz, Roxana Mehran, John McPherson, Naim Farhat, Steven P. Marso, Helen Parise, Barry Templin, Roseann White, Zhen Zhang, Patrick W. Serruys. A Prospective Natural-History Study of Coronary Atherosclerosis. New England Journal of Medicine, 2011; 364 (3): 226 DOI: 10.1056/NEJMoa1002358
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