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CLINICAL RESEARCH: CLINICAL TRIALS

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, MD^_*, Takeshi Kimura, MD, Takeshi Morimoto, MD, Katsumi Miyauchi, MD, Yoshihisa Nakagawa, MD^||, Masakazu Yamagishi, MD^¶, Yukio Ozaki, MD^#, Kazuo Kimura, MD^_**, Satoshi Saito, MD, Tetsu Yamaguchi, MD, Hiroyuki Daida, MD, Masunori Matsuzaki, MD^_*,_* for the JAPAN-ACS Investigators

^_* Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
Center for Medical Education, Kyoto University Graduate School of Medicine, Kyoto, Japan
Department of Cardiology, Juntendo University School of Medicine, Tokyo, Japan
^|| Department of Cardiology, Tenri Hospital, Nara, Japan
^¶ Division of Cardiovascular Medicine, Kanazawa University Graduate School of Medicine, Kanazawa, Japan
^# Division of Cardiology, Fujita Health University, Toyoake, Japan
^_** Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
Department of Integrative Health Medicine, Nihon University School of Medicine, Tokyo, Japan
Toranomon Hospital, Tokyo, Japan

Manuscript received December 2, 2008; revised manuscript received March 23, 2009, accepted April 2, 2009.

^_* Reprint requests and correspondence: Dr. Masunori Matsuzaki, Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan (Email: masunori{at}yamaguchi-u.ac.jp).

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).

Key Words: acute coronary syndrome • plaque • statins • intravascular ultrasound

Abbreviations and Acronyms   ACS = acute coronary syndrome   CRP = C-reactive protein   EEM = external elastic membrane   FAS = full analysis set   HDL-C = high-density lipoprotein cholesterol   IVUS = intravascular ultrasound   LDL-C = low-density lipoprotein cholesterol   PCI = percutaneous coronary intervention   PV = plaque volume

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