CORRESPONDENCE: LETTER TO THE EDITOR
Reply
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 and
Masunori Matsuzaki, MD*
* Department of Medicine and Clinical Science, Division of Cardiology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan (Email: masunori{at}yamaguchi-u.ac.jp).
First, we express our deep appreciation for the sincere criticism by Dr. Kaneda and colleagues of our paper (1). However, we have a few concerns regarding their arguments.- 1 The REVERSAL (REVERSing Atherosclerosis with Aggressive Lipid Lowering) study (2) examined patients with stable coronary artery disease who could undergo an elective cardiac catheterization, whereas the PROVE-IT–TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy–Thrombolysis In Myocardial Infarction 22) (3) and our JAPAN-ACS (Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome) study examined patients with acute coronary syndrome. Several reports have been published that nonculprit plaque differs in tissue characteristics between acute coronary syndrome and stable coronary artery disease. Therefore, extrapolations of the data between the REVERSAL and the PROVE-IT–TIMI 22 studies have major limitations.
- 2 Their criticism was not based on any kind of rational statistical meta-analysis. The value of the difference in the mean percentage of change in plaque volume of 1.3% in the REVERSAL study cannot necessarily be considered similar to the 1.1% in our study. The value of 1.3% of the REVERSAL study came from the difference between 5.4% and 4.1%, whereas the value of 1.1% in our study resulted from the difference between –16.9% and –18.1%. Therefore, 1.3% of the REVERSAL study might be considerably more remarkable than 1.1% in our study.
- 3 The intravenous ultrasound measurement of plaque volume differed between the REVERSAL study and our study. The REVERSAL study measured the longer segment with a total of 30 mm or more integrated with 1-mm interval cross-sectional area tracings, whereas our study measured a specific plaque segment of a total length of approximately 7 mm with 0.1-mm interval tracings. Therefore, even a similar difference in the mean percentage of change in plaque volume in the REVERSAL study might have a more significant clinical impact on future cardiac events than that in our study.
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References
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1. Hiro T, Kimura T, Morimoto T, et al. 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) J Am Coll Cardiol 2009;54:293-302.[Abstract/Free Full Text]2. Nissen SE, Tuzcu EM, Schoenhagen P, et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial JAMA 2004;291:1071-1080.[Abstract/Free Full Text] 3. Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes N Engl J Med 2004;350:1495-1504.[CrossRef][Web of Science][Medline]
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Noninferiority of Pitavastatin in Intravascular Ultrasound Findings
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