Author + information
- Hideaki Kaneda, MD, PhD* (, )
- Ji Ma, MD and
- Toshihiro Morita, MD, PhD
- ↵*Tokyo Heart Center, 5-4-12 Kita-shinagawa, Tokyo 141-0001, Japan
We read with interest the paper by Hiro et al. (1) comparing the regressive effect of pitavastatin on coronary plaque volume in acute coronary syndrome patients with that of atorvastatin using intravascular ultrasound (IVUS). The authors demonstrated that the upper limit of the 95% confidence interval of the difference in the mean percentage of change in plaque volume between the 2 groups (mean 1.11%, 95% confidence interval: −2.27% to 4.48%) did not exceed the pre-defined noninferiority margin of 5% and concluded that the noninferiority of pitavastatin compared with atorvastatin.
However, although an IVUS study comparing pravastatin with atorvastatin demonstrated a similar result (the difference in the mean percentage of change in atheroma volume was 1.3%, 5.4% in the pravastatin group and 4.1% in the atorvastatin group) (2), a clinical end point study (n = 4,162) using the same drugs demonstrated a significant difference in death or major cardiovascular event rates (26.3% in the pravastatin group and 22.4% in the atorvastatin group) (3). Therefore, it remains uncertain whether the noninferiority of pitavastatin in IVUS findings would translate to clinical noninferiority (4). Even such a small difference in IVUS findings may lead to a significant difference in clinical event rates in a large clinical trial.
- American College of Cardiology Foundation
- Hiro T.,
- Kimura T.,
- Morimoto T.,
- et al.
- Tobis J.M.,
- Perlowski A.