Impact of Dual Lipid-Lowering Strategy With Ezetimibe and Atorvastatin on Coronary Plaque Regression in Patients With Percutaneous Coronary Intervention: The Multicenter Randomized Controlled PRECISE-IVUS Trial
- PMID: 26227186
- DOI: 10.1016/j.jacc.2015.05.065
Impact of Dual Lipid-Lowering Strategy With Ezetimibe and Atorvastatin on Coronary Plaque Regression in Patients With Percutaneous Coronary Intervention: The Multicenter Randomized Controlled PRECISE-IVUS Trial
Abstract
Background: Despite standard statin therapy, a majority of patients retain a high "residual risk" of cardiovascular events.
Objectives: The aim of this study was to evaluate the effects of ezetimibe plus atorvastatin versus atorvastatin monotherapy on the lipid profile and coronary atherosclerosis in Japanese patients who underwent percutaneous coronary intervention (PCI).
Methods: This trial was a prospective, randomized, controlled, multicenter study. Eligible patients who underwent PCI were randomly assigned to atorvastatin alone or atorvastatin plus ezetimibe (10 mg) daily. Atorvastatin was uptitrated with a treatment goal of low-density lipoprotein cholesterol (LDL-C) <70 mg/dl. Serial volumetric intravascular ultrasound was performed at baseline and again at 9 to 12 months to quantify the coronary plaque response in 202 patients.
Results: The combination of atorvastatin/ezetimibe resulted in lower levels of LDL-C than atorvastatin monotherapy (63.2 ± 16.3 mg/dl vs. 73.3 ± 20.3 mg/dl; p < 0.001). For the absolute change in percent atheroma volume (PAV), the mean difference between the 2 groups (-1.538%; 95% confidence interval [CI]: -3.079% to 0.003%) did not exceed the pre-defined noninferiority margin of 3%, but the absolute change in PAV did show superiority for the dual lipid-lowering strategy (-1.4%; 95% CI: -3.4% to -0.1% vs. -0.3%; 95% CI: -1.9% to 0.9% with atorvastatin alone; p = 0.001). For PAV, a significantly greater percentage of patients who received atorvastatin/ezetimibe showed coronary plaque regression (78% vs. 58%; p = 0.004). Both strategies had acceptable side effect profiles, with a low incidence of laboratory abnormalities and cardiovascular events.
Conclusions: Compared with standard statin monotherapy, the combination of statin plus ezetimibe showed greater coronary plaque regression, which might be attributed to cholesterol absorption inhibition-induced aggressive lipid lowering. (Plaque Regression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound [PRECISE-IVUS]; NCT01043380).
Keywords: HMG-CoA reductase inhibitors; intravascular ultrasound.
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Comment in
-
Ezetimibe and Plaque Regression: Cholesterol Lowering or Pleiotropic Effects?J Am Coll Cardiol. 2015 Aug 4;66(5):508-10. doi: 10.1016/j.jacc.2015.05.064. J Am Coll Cardiol. 2015. PMID: 26227187 No abstract available.
-
Intriguing Off-Target Effects of Ezetimibe.J Am Coll Cardiol. 2015 Dec 22;66(24):2808. doi: 10.1016/j.jacc.2015.08.1130. J Am Coll Cardiol. 2015. PMID: 26700841 No abstract available.
-
Reply: Intriguing Off-Target Effects of Ezetimibe.J Am Coll Cardiol. 2015 Dec 22;66(24):2808-2809. doi: 10.1016/j.jacc.2015.09.091. J Am Coll Cardiol. 2015. PMID: 26700842 No abstract available.
-
Evaluating Statin Versus Statin Plus Ezetimibe for Coronary Plaque Regression.J Am Coll Cardiol. 2015 Dec 29;66(25):2916. doi: 10.1016/j.jacc.2015.08.1131. J Am Coll Cardiol. 2015. PMID: 26718684 No abstract available.
-
Reply: Evaluating Statin Versus Statin Plus Ezetimibe for Coronary Plaque Regression.J Am Coll Cardiol. 2015 Dec 29;66(25):2916-2917. doi: 10.1016/j.jacc.2015.09.098. J Am Coll Cardiol. 2015. PMID: 26718685 No abstract available.
-
Getting What the Guidelines Stated Matters.J Am Coll Cardiol. 2016 Jan 5;67(1):119-20. doi: 10.1016/j.jacc.2015.08.1132. J Am Coll Cardiol. 2016. PMID: 26764076 No abstract available.
-
Reply: Getting What the Guidelines Stated Matters.J Am Coll Cardiol. 2016 Jan 5;67(1):120-1. doi: 10.1016/j.jacc.2015.10.041. J Am Coll Cardiol. 2016. PMID: 26764077 No abstract available.
-
Reply: Dual Lipid-Lowering Strategy With Ezetimibe and Atorvastatin on Coronary Plaque Regression After PCI: PRECISE-IVUS.J Am Coll Cardiol. 2016 Jan 19;67(2):234-235. doi: 10.1016/j.jacc.2015.10.053. J Am Coll Cardiol. 2016. PMID: 26791071 No abstract available.
-
Dual Lipid-Lowering Strategy With Ezetimibe and Atorvastatin on Coronary Plaque Regression After PCI: PRECISE-IVUS.J Am Coll Cardiol. 2016 Jan 19;67(2):234. doi: 10.1016/j.jacc.2015.09.105. J Am Coll Cardiol. 2016. PMID: 26791072 No abstract available.
Publication types
MeSH terms
Substances
Associated data
LinkOut - more resources
Full Text Sources
Medical
Miscellaneous