Abstract 14134: Effects of Statin Plus Ezetimibe versus Statin Alone on Coronary Atherosclerosis in Acute Coronary Syndrome

Abstract

Introduction: IMPROVE-IT trial showed that ezetimibe plus statin treatment, as compared with statin alone, decreased cardiovascular events in patients with acute coronary syndrome (ACS). However, proir studies have failed to show a beneficial effect of ezetimibe on carotid plaque progression when added to statin treatment. Hypothesis: The addition of ezetimibe to statin therapy affects coronary plaque behavior in the non-culprit vessel. Methods: We conducted a prospective, randomized open-label parallel group study with blind endpoint evaluation conducted at 10 centers in Japan. A total of 128 statin naïve patients with ACS undergoing intravascular ultrasound (IVUS) guided percutaneous coronary intervention were randomized and nonculprit coronary lesions associated with mild-to-moderate stenosis in 103 patients had evaluable IVUS examinations at baseline and at 8 to 12 months follow-up. Conventional IVUS and integrated backscatter (IB)-IVUS measurements at 1-mm intervals were calculated. Patients were randomly assigned to receive either 2mg/day of pitavastatin plus 10mg/day ezetimibe or 2mg/day of pitavastatin. Primary endpoints were the percentage change in non-culprit coronary plaque volume and percent change in lipid plaque volume. Results: Mean low density lipoprotein cholesterol was reduced from 125mg/dl to 65mg/dl in the combination therapy group receiving statin plus ezetimibe (n=50) and 126mg/dl to 87 mg/dl in the statin alone group (n=53)(between group difference of 16.9%, P<0.0001). Length of analyzed segment did not differ between the groups (median 38.0 vs. 41.2 mm, p=0.40). The primary endpoint, percent change in plaque volume, was -5.1% in the combination therapy group and -6.2% in the statin alone group (P=0.66), although both groups resulted in reduction of plaque volume compared with baseline (both p=0.001). The percent change in lipid plaque volume did not differ between the groups (4.3 vs. -3.0%, P=0.37). Conclusions: Among patients with acute coronary syndrome, combined therapy with ezetimibe and statin did not result in a significant change in coronary plaque regression or tissue component compared with statin alone.