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)

Takafumi Hiro, Takeshi Kimura, Takeshi Morimoto, Katsumi Miyauchi, Yoshihisa Nakagawa, Masakazu Yamagishi, Yukio Ozaki, Kazuo Kimura, Satoshi Saito, Tetsu Yamaguchi, Hiroyuki Daida, Masunori Matsuzaki

Research output: Contribution to journalArticle

259 Citations (Scopus)

Abstract

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).

Original languageEnglish
Pages (from-to)293-302
Number of pages10
JournalJournal of the American College of Cardiology
Volume54
Issue number4
DOIs
Publication statusPublished - 21-07-2009

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Acute Coronary Syndrome
Multicenter Studies
Coronary Artery Disease
Japan
Therapeutics
Confidence Intervals
Atorvastatin Calcium
pitavastatin
Percutaneous Coronary Intervention
Lipids

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

@article{02dc7673dd5f4be9b144a6d365ad9247,
title = "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)",
abstract = "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).",
author = "Takafumi Hiro and Takeshi Kimura and Takeshi Morimoto and Katsumi Miyauchi and Yoshihisa Nakagawa and Masakazu Yamagishi and Yukio Ozaki and Kazuo Kimura and Satoshi Saito and Tetsu Yamaguchi and Hiroyuki Daida and Masunori Matsuzaki",
year = "2009",
month = "7",
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doi = "10.1016/j.jacc.2009.04.033",
language = "English",
volume = "54",
pages = "293--302",
journal = "Journal of the American College of Cardiology",
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}

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). / Hiro, Takafumi; Kimura, Takeshi; Morimoto, Takeshi; Miyauchi, Katsumi; Nakagawa, Yoshihisa; Yamagishi, Masakazu; Ozaki, Yukio; Kimura, Kazuo; Saito, Satoshi; Yamaguchi, Tetsu; Daida, Hiroyuki; Matsuzaki, Masunori.

In: Journal of the American College of Cardiology, Vol. 54, No. 4, 21.07.2009, p. 293-302.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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)

AU - Hiro, Takafumi

AU - Kimura, Takeshi

AU - Morimoto, Takeshi

AU - Miyauchi, Katsumi

AU - Nakagawa, Yoshihisa

AU - Yamagishi, Masakazu

AU - Ozaki, Yukio

AU - Kimura, Kazuo

AU - Saito, Satoshi

AU - Yamaguchi, Tetsu

AU - Daida, Hiroyuki

AU - Matsuzaki, Masunori

PY - 2009/7/21

Y1 - 2009/7/21

N2 - 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).

AB - 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).

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U2 - 10.1016/j.jacc.2009.04.033

DO - 10.1016/j.jacc.2009.04.033

M3 - Article

VL - 54

SP - 293

EP - 302

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 4

ER -