Document Detail


Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN-ACS [Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome] study).
MedLine Citation:
PMID:  19608026     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: The objective of this study was to evaluate whether the regressive effects of aggressive lipid-lowering therapy with atorvastatin on coronary plaque volume (PV) in patients with acute coronary syndrome (ACS) are generalized for other statins in multicenter setting. BACKGROUND: A previous single-center study reported beneficial regressive effects of atorvastatin in patients with ACS on PV of the nonculprit site by intravascular ultrasound (IVUS) evaluation. The effect of statins other than atorvastatin on PV has not been evaluated in the setting of ACS. METHODS: The JAPAN-ACS (Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome) study was a prospective, randomized, open-label, parallel group study with blind end point evaluation conducted at 33 centers in Japan. A total of 307 patients with ACS undergoing IVUS-guided percutaneous coronary intervention were randomized, and 252 patients had evaluable IVUS examinations at baseline and 8 to 12 months' follow-up. Patients were randomly assigned to receive either 4 mg/day of pitavastatin or 20 mg/day of atorvastatin. The primary end point was the percentage change in nonculprit coronary PV. RESULTS: The mean percentage change in PV was -16.9 +/- 13.9% and -18.1 +/- 14.2% (p = 0.5) in the pitavastatin and atorvastatin groups, respectively, which was associated with negative vessel remodeling. The upper limit of 95% confidence interval of the mean difference in percentage change in PV between the 2 groups (1.11%, 95% confidence interval: -2.27 to 4.48) did not exceed the pre-defined noninferiority margin of 5%. CONCLUSIONS: The administration of pitavastatin or atorvastatin in patients with ACS equivalently resulted in significant regression of coronary PV (Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome; NCT00242944).
Authors:
Takafumi Hiro; Takeshi Kimura; Takeshi Morimoto; Katsumi Miyauchi; Yoshihisa Nakagawa; Masakazu Yamagishi; Yukio Ozaki; Kazuo Kimura; Satoshi Saito; Tetsu Yamaguchi; Hiroyuki Daida; Masunori Matsuzaki;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  54     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2009 Jul 
Date Detail:
Created Date:  2009-07-17     Completed Date:  2009-08-31     Revised Date:  2010-02-04    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  293-302     Citation Subset:  AIM; IM    
Affiliation:
Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00242944
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MeSH Terms
Descriptor/Qualifier:
Acute Coronary Syndrome / drug therapy*,  pathology
Aged
Coronary Artery Disease / drug therapy*,  pathology
Coronary Vessels / pathology,  ultrasonography
Female
Heptanoic Acids / administration & dosage*
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
Male
Middle Aged
Pyrroles / administration & dosage*
Quinolines / administration & dosage*
Treatment Outcome
Ultrasonography, Interventional
Chemical
Reg. No./Substance:
0/Heptanoic Acids; 0/Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0/Pyrroles; 0/Quinolines; 110862-48-1/atorvastatin; 147526-32-7/NK 104
Investigator
Investigator/Affiliation:
Izumi Miki / ; Saeko Minematsu / ; Hiroko Kanou / ; Natsuko Yamamoto / ; Tatsuhiro Fujimura / ; Genta Hashimoto /
Comments/Corrections
Comment In:
J Am Coll Cardiol. 2010 Jan 19;55(3):262-3; author reply 263   [PMID:  20117416 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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