Atherosclerosis imaging in progression/regression trials: surrogate marker or direct window into the atherosclerotic disease process?
CAD remains a major global cause of morbidity and mortality. Comprehensive drug development programs of novel pharmacological treatment strategies frequently utilize traditional mortality/morbidity endpoints studies and additional surrogate endpoints trials. This parallel approach allows an assessment of efficacy several years in advance of the availability of data from clinical endpoint trials. Several atherosclerosis imaging markers have been introduced into these drug-development strategies, including angiography, carotid ultrasound, IVUS, MRI, and CT. This review will discuss the current status of atherosclerosis imaging as an endpoint in progression/regression trials, with an emphasis on evidence-based data. In addition to a discussion of the results of individual imaging modalities, the emerging data comparing different modalities and approaches are presented.
Schoenhagen
Paul
P
Cleveland Clinic, Imaging Institute and Heart & Vascular Institute, Cleveland 44195, USA. schoenp1@ccf.org
Tuzcu
E Murat
EM
D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D050197:Atherosclerosis / Q000175:diagnosis* / Q000473:pathology / Q000628:therapy; D002114:Calcinosis / Q000175:diagnosis; D002986:Clinical Trials as Topic; D003952:Diagnostic Imaging / Q000379:methods*; D018450:Disease Progression; D006801:Humans; D012074:Remission Induction; D018084:Ultrasonography, Interventional / Q000379:methods