Treatment With Statin on Atheroma Regression Evaluated by Intravascular Ultrasound With Virtual Histology (TRUTH Study): Rationale and Design

• Published in: Circulation Journal 2009, Vol.73(2), pp.352-355
• Main Authors: Nozue, Tsuyoshi, Yamamoto, Shingo, Tohyama, Shinichi, Umezawa, Shigeo, Kunishima, Tomoyuki, Sato, Akira, Miyake, Shogo, Takeyama, Youichi, Morino, Yoshihiro, Yamauchi, Takao, Muramatsu, Toshiya, Hibi, Kiyoshi, Sozu, Takashi, Michishita, Ichiro, Kanagawa PTCA Conference Study Group
• Format: Article
• Language: English
• Subjects: Atherosclerosis - diagnostic imaging; Atherosclerosis - drug therapy; Coronary artery disease; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - drug therapy; Coronary Vessels - diagnostic imaging; Endpoint Determination; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Japan; Plaque composition; Pravastatin - adverse effects; Pravastatin - therapeutic use; Prospective Studies; Quinolines - adverse effects; Quinolines - therapeutic use; Statins; Ultrasonography, Interventional; User-Computer Interface; Virtual HistologyTM intravascular ultrasound (VH-IVUS)
• ISSN: 1346-9843; 1347-4820
• DOI: 10.1253/circj.CJ-08-0593

Background Many clinical trials have shown that 3-hydroxy-3-methylglutaryl-conenzyme A reductase inhibitors (statins) can significantly reduce the incidence of coronary artery disease in both primary and secondary prevention. A recent study showed that aggressive lipid-lowering therapy with statins could achieve regression of coronary artery plaque evaluated with gray-scale intravascular ultrasound (IVUS). However, the actual changes in coronary artery plaque composition produced by statin therapy have not been well delineated. Methods and Results This study will be a prospective, open-label, randomized multicenter study of 160 patients with stable or unstable angina who have undergone percutaneous coronary intervention with Virtual HistologyTM IVUS (VH-IVUS). Patients will be randomly assigned to either the pitavastatin or pravastatin group. After treatment for 24-40 weeks, VH-IVUS will be performed again in the same segment of the coronary artery. The primary endpoint will be quantitative changes in each of the 4 components measured by VH-IVUS. Conclusion The treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology (TRUTH) study will be the first multicenter study using VH-IVUS to evaluate the effects of statins on changes in coronary artery plaque composition and the findings will clarify the mechanisms of coronary artery plaque stabilization. (Circ J 2009; 73: 352 - 355)