Serial intravascular ultrasound assessment of atherosclerosis progression and regression. State-of-the-art and limitations.
Coronary heart disease remains a leading cause of morbidity and mortality. Surrogate imaging endpoints may allow smaller sample sizes and shorter study durations to expedite the process of drug development and testing, and to evaluate potential benefits of novel antiatherosclerotic drugs before clinical endpoint data are available - an approach that may reduce cost and effort. Intravascular ultrasound (IVUS) is particularly suitable because it is readily available and because of its relatively high image resolution, accurate and reproducible measurements, ability to detect mild, angiographically silent atherosclerotic disease that can be a precursor of future coronary events, and suitability for serial (baseline and follow-up) imaging and analysis. However, there are significant limitations to the use of IVUS as an endpoint in progression/regression studies that must be considered when evaluating the results of such studies.
Mintz
Gary S
GS
Cardiovascular Research Foundation, New York, NY 10022, USA. gmintz@crf.org
Maehara
Akiko
A
D002317:Cardiovascular Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000188:drug therapy; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D018450:Disease Progression; D019317:Evidence-Based Medicine; D006801:Humans; D011237:Predictive Value of Tests; D012107:Research Design; D012720:Severity of Illness Index; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D002317:Cardiovascular Agents