title: 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.
  
  
  OBJECTIVE
  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).
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. Electronic address: tsujita@kumamoto-u.ac.jp.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Tsujita
authors.affiliation: Diabetes Care Center, Cardiovascular Division, Jinnouchi Hospital, Kumamoto, Japan.
authors.forename: Seigo
authors.initials: S
authors.lastname: Sugiyama
authors.affiliation: Division of Cardiology, Kumamoto Central Hospital, Kumamoto, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sumida
authors.affiliation: Department of Cardiovascular Medicine, Fukuoka Tokushukai Medical Center, Kasuga, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Shimomura
authors.affiliation: Division of Cardiology, Social Insurance Omuta Tenryo Hospital, Omuta, Japan.
authors.forename: Takuro
authors.initials: T
authors.lastname: Yamashita
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Kenshi
authors.initials: K
authors.lastname: Yamanaga
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Naohiro
authors.initials: N
authors.lastname: Komura
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Sakamoto
authors.affiliation: Division of Cardiology, Health Insurance Hitoyoshi General Hospital, Hitoyoshi, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Oka
authors.affiliation: Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Nakao
authors.affiliation: Interventional Cardiology Unit, New Tokyo Hospital, Matsudo, Japan.
authors.forename: Sunao
authors.initials: S
authors.lastname: Nakamura
authors.affiliation: Division of Coronary Artery Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: Masaharu
authors.initials: M
authors.lastname: Ishihara
authors.affiliation: Department of Community Medicine, Kumamoto University, Kumamoto, Japan.
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Matsui
authors.affiliation: Division of Cardiology, Amakusa Medical Center, Amakusa, Japan.
authors.forename: Naritsugu
authors.initials: N
authors.lastname: Sakaino
authors.affiliation: Division of Cardiology, Shin-Beppu Hospital, Beppu, Japan.
authors.forename: Natsuki
authors.initials: N
authors.lastname: Nakamura
authors.affiliation: Division of Cardiology, Miyazaki Prefectural Nobeoka Hospital, Nobeoka, Japan.
authors.forename: Nobuyasu
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Division of Cardiology, Health Insurance Kumamoto General Hospital, Yatsushiro, Japan.
authors.forename: Shunichi
authors.initials: S
authors.lastname: Koide
authors.affiliation: Division of Cardiology, Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital, Yatsushiro, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Matsumura
authors.affiliation: Department of Cardiology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
authors.forename: Kazuteru
authors.initials: K
authors.lastname: Fujimoto
authors.affiliation: Division of Cardiology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.
authors.forename: Ryusuke
authors.initials: R
authors.lastname: Tsunoda
authors.affiliation: Division of Cardiology, Kumamoto City Hospital, Kumamoto, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Morikami
authors.affiliation: Division of Cardiology, Social Insurance Omuta Tenryo Hospital, Omuta, Japan.
authors.forename: Koushi
authors.initials: K
authors.lastname: Matsuyama
authors.affiliation: Division of Cardiology, Kumamoto Central Hospital, Kumamoto, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Oshima
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Kaikita
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Hokimoto
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan; Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
mesh_terms: D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000069059:Atorvastatin; D001384:Azetidines / Q000008:administration & dosage / Q000009:adverse effects; D008078:Cholesterol, LDL / Q000097:blood; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D000069438:Ezetimibe; D005260:Female; D006538:Heptanoic Acids / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D058226:Plaque, Atherosclerotic / Q000000981:diagnostic imaging / Q000188:drug therapy; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods
chemical_list: D000924:Anticholesteremic Agents; D001384:Azetidines; D008078:Cholesterol, LDL; D006538:Heptanoic Acids; D011758:Pyrroles; D000069059:Atorvastatin; D000069438:Ezetimibe
keywords: HMG-CoA reductase inhibitors; intravascular ultrasound