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Coronary atherosclerotic disease burden: an emerging endpoint in progression/regression studies using intravascular
Paul Schoenhagen1, Steven E Nissen
1The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. schoenp1@ccf.org
Insights
Coronary artery disease (CAD) events often stem from vulnerable plaques. Intravascular ultrasound (IVUS) offers a novel imaging endpoint for studying plaque burden and morphology in clinical trials.
Area of Science:
- Cardiology
- Medical Imaging
Background:
- Coronary artery disease (CAD) is a leading cause of mortality in Western countries.
- Acute coronary events, such as myocardial infarction (MI), are frequently caused by vulnerable plaque rupture and thrombosis.
- Vulnerable plaques are often present years before clinical manifestation, posing a challenge for primary prevention trials.
Purpose of the Study:
- To review the rationale for using coronary plaque imaging as an endpoint in clinical studies.
- To describe the application of intravascular ultrasound (IVUS) for assessing coronary plaque burden and morphology.
Main Methods:
- Review of existing literature on CAD, plaque vulnerability, and imaging modalities.
- Focus on the methodology and application of intravascular ultrasound (IVUS) in serial studies.
Main Results:
- Vulnerable plaques are prevalent in asymptomatic individuals long before clinical events.
- Pharmacological studies targeting MI and death require large populations and extended follow-up.
- In vivo imaging, specifically IVUS, provides a viable alternative endpoint for assessing plaque progression.
Conclusions:
- Direct observation of coronary plaque using imaging modalities like IVUS can serve as an effective endpoint in clinical trials.
- IVUS allows for detailed assessment of plaque burden and morphology, aiding in the evaluation of preventative strategies for CAD.
Abstract:
Coronary artery disease (CAD) represents the major cause of mortality in North America and Western Europe. Most acute coronary events, including myocardial infarction (MI) and sudden cardiac death, are initiated by the sudden rupture of mildly stenotic but vulnerable lesions and subsequent thrombosis. Recent results demonstrate a high prevalence of such plaques many years before clinical events occur. Because the event rate in asymptomatic patients, which would be candidate for primary prevention, is relatively low, pharmacological studies with the endpoint of MI and death require large study populations and long follow-up. Alternatively, the direct observation of coronary plaque burden and morphology with in vivo imaging modalities has been proposed as an endpoint in serial studies. This review will summarize the rational of this approach and describe the use of intravascular ultrasound (IVUS) for such studies.