The ability of high dose rosuvastatin to improve plaque composition in non-intervened coronary arteries: rationale and design of the Integrated Biomarker and Imaging Study-3 (IBIS-3).
OBJECTIVE
Acute coronary syndromes (ACS) are often caused by rupture of non-flow limiting "vulnerable" atherosclerotic plaque, characterised by a large necrotic core pool and a thin, inflamed fibrous cap that are unidentifiable with diagnostic coronary angiography. The implementation of novel invasive imaging modalities, such as intravascular ultrasound-virtual histology (IVUS-VH) and near-infrared spectroscopy (NIRS), could help identify high-risk patients who are in need of aggressive medical therapy. The intake of high dose rosuvastatin has been shown to reduce plaque containing necrotic core in the carotid arteries, however it remains unknown whether there is a similar effect in the coronary arteries.


RESULTS
The IBIS-3 study is a single centre, non-randomised study designed to evaluate the ability of 12-months high dose rosuvastatin treatment (40 mg daily po) to reduce the necrotic core of a non-intervened coronary segment assessed with IVUS-VH. All patients undergoing diagnostic angiography or percutaneous coronary intervention (PCI) are eligible for participation. Recruitment started in early 2010 and will continue until 350 patients are included. The effect on the lipid core containing plaque will be assessed with near-infrared spectroscopy (NIRS) at 12-months. In addition, multiple biomarkers will be measured and their levels correlated with the imaging results.


CONCLUSIONS
IBIS-3 will assess the efficacy of high dose rosuvastatin to reduce the necrotic core in a coronary segment of patients who have undergone diagnostic angiography or PCI.
Thoraxcenter, Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
Cihan
C
Simsek
Hector M
HM
Garcia-Garcia
Robert-Jan
RJ
van Geuns
Michael
M
Magro
Chrysafios
C
Girasis
Nicolas
N
van Mieghem
Mattie
M
Lenzen
Sanneke
S
de Boer
Evelyn
E
Regar
Willem
W
van der Giessen
Joel
J
Raichlen
Henricus J
HJ
Duckers
Felix
F
Zijlstra
Ton
T
van der Steen
Eric
E
Boersma
Patrick W
PW
Serruys
D015415:Biomarkers; D003324:Coronary Artery Disease / Q000188:drug therapy*; D005464:Fluorobenzenes / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D058226:Plaque, Atherosclerotic / Q000188:drug therapy*; D011446:Prospective Studies; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D000068718:Rosuvastatin Calcium; D019265:Spectroscopy, Near-Infrared; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D018084:Ultrasonography, Interventional
D015415:Biomarkers; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium