Moderate-intensity statin and ezetimibe combination therapy versus high-intensity statin on coronary atherosclerotic plaque

BACKGROUND: Effect of moderate-intensity statin and ezetimibe is known to be non-inferior to high-intensity statin in prevention of adverse clinical events in patients with coronary atherosclerotic disease. However, data regarding regression of coronary atherosclerotic plaque remains limited. METHODS: In this randomized, non-inferiority trial, patients with intermediate coronary artery stenosis were randomly assigned 1:1 to either moderate-intensity rosuvastatin (10 mg) with ezetimibe or high-intensity rosuvastatin (20 mg) group. Intravascular ultrasound (IVUS) was performed at baseline and after 12 months or longer to quantify the coronary plaque response. Primary end point was absolute changes in percent atheroma volume (PAV) between baseline and follow-up IVUS, and non-inferiority margin was as 2.5%. Secondary end point was major adverse cardiovascular events (MACE), which was a composite of cardiac death, myocardial infarction, and unplanned repeat revascularization. RESULTS: A total of 280 patients underwent randomization. Follow-up IVUS showed absolute changes in PAV were - 1.286 ± 3.704% and - 1.302 ± 3.586%, respectively for moderate-intensity rosuvastatin and ezetimibe group and high-intensity rosuvastatin group. Mean difference between 2 groups (0.017%; 95% confidence interval: -0.957% to 0.991%) did not exceed noninferiority margin (non-inferiority p < 0.001). Both groups showed acceptable side effect profiles without group differences. CONCLUSION: Compared with high-intensity rosuvastatin monotherapy, moderate-intensity rosuvastatin and ezetimibe was non-inferior regarding regression of coronary atherosclerotic plaque (Supported by Hanmi Pharmaceutical co., ltd; ROSUZET-IVUS ClinicalTrials.gov number, NCT03169985).