The Effects of Pravastatin and Rosuvastatin on Coronary Plaques in Patients With Stable Angina Pectoris
The Effects of Pravastatin and Rosuvastatin on Coronary Plaques in Patients With Stable Angina Pectoris
The purpose of this study is to compare the effects of pravastatin and rosuvastatin on
 coronary plaque characteristics in patients with stable angina pectoris.
Previous mega trials have demonstrated that lipid-lowering therapy with HMG-CoA reductase
 inhibitors in individuals with high risk of cardiovascular disease reduces the incidence of
 coronary heart disease. NCEP ATP-III has suggested the advantage of more intensive lipid
 lowering therapy with a goal of reducing LDL-C below 70 mg/dL for such patients categorized
 as very high risk. In Japan, Japan Atherosclerosis Society (JAS) Guidelines for Diagnosis and
 Treatment of Atherosclerotic Cardiovascular Diseases 2002 have recommended that an LDL-C goal
 for patients with coronary heart disease (CHD) should be below 100 mg/dL. However, there is
 no satisfactory evidence whether the investigators need to lower LDL-C level less than the
 70mg/dL or not in Japanese population.

 Recently, research on diagnosis of coronary plaque has shown significant advances. The
 REVERSAL study in patients with a history of CHD, by diagnosis with intravascular ultrasound
 (IVUS), suggested that intensive lipid lowering therapy with atorvastatin (80 mg/day) was
 associated with no growth of plaque (-0.4% compared to baseline), whereas therapy with
 pravastatin (40 mg/day) showed a slight increase (2.7%) in plaque volume over 18 months in
 Western population.

 MEGA study has shown that lipid lowering therapy with pravastatin (10-20 mg/day) was
 associated with a 33% reduction in coronary heart disease incidence as the primary prevention
 in Japanese patients. However, the effect of lipid lowering therapy in secondary prevention
 of cardiovascular events is unknown.

 Relative plaque regression rate between intensive and moderate lipid lowering therapy would
 clarify the ideal level of target LDL-C in Japanese population. Furthermore, the different
 effect on coronary plaque between pravastatin and rosuvastatin which have different LDL-C
 lowering effect and different affinity to arterial tissue would determine the superior lipid
 lowering regimen to affect coronary plaque volume.

 Therefore, the aim of the present study is to evaluate whether there would be lipid lowering
 therapy differences in terms of the composition of coronary artery plaques in patients with
 stable angina pectoris (SAP) using integrated backscatter intravascular ultrasound (IB-IVUS)
 and optical coherence tomography (OCT).
Inclusion Criteria:

 1. Patients who have been diagnosed as stable angina pectoris, and successful
 percutaneous coronary intervention (PCI) were performed with intravascular ultrasound
 (IVUS) and optical coherence tomography (OCT) guidance.

 2. Patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at
 ≧ 5 mm distal or proximal to the previously treated area in the same branch of
 coronary artery.

 3. Patients with dyslipidemia as defined by any of the following criteria:

 -  TC ≧ 220 mg/dL

 -  LDL-C ≧ 140 mg/dL

 -  Cholesterol-lowering treatment is allowed according to the investigator's
 judgment when LDL-C ≧ 100 mg/dL or TC ≧ 180mg/dL.

 -  Patients who are under cholesterol-lowering treatment and LDL-C ≦ 120 mg/dL

 4. Patients 20 years or older at the time of their consent.

 5. Patients with written consent by their own volition after being provided sufficient
 explanation for their participation in this clinical trial.

 Exclusion Criteria:

 1. Patients with bypass graft or in-stent restenosis at the site of PCI.

 2. Patients who received PCI in the past on the lesion where the evaluation of coronary
 plaque volume is planned.

 3. Patients who had plaques in a non-culprit site and might receive PCI during the
 treatment period.

 4. Patients receiving lipid-lowering drugs (fibrates, probucol, nicotinic acid,
 cholestyramine or cholesterol absorption inhibitors).

 5. Patients with familial hypercholesterolemia.

 6. Patients with cardiogenic shock.

 7. Patients receiving cyclosporine.

 8. Patients with any allergy to pravastatin and rosuvastatin.

 9. Patients with hepatobiliary disorders.

 10. Pregnant women, women suspected of being pregnant, or lactating women.

 11. Patients with renal disorders (Cr≧2.0mg/dL) or undergoing dialysis.

 12. Patients who are ineligible in the opinion of the investigator.