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
N1 - Funding Information:
The Japan Heart Foundation funded this study with an unrestricted grant from Kowa Pharmaceutical. Kowa Pharmaceutical participated in the preparation of the study design. However, investigators or the independent Clinical Research Coordinator (see Acknowledgments) made the final decision on the study design and database maintenance, wrote the manuscript, and decided to submit the article. An independent statistician (see Online Appendix ) analyzed the data. Dr. Hiro has received honoraria for lectures from Kowa Pharmaceutical, Pfizer, and Astellas Pharma. Dr. Kimura is an advisory member of Kowa Pharmaceutical and Pfizer, and has received honoraria for lectures from Kowa Pharmaceutical, Pfizer, and Astellas Pharma. Dr. Morimoto has received honoraria for lectures from Kowa Pharmaceutical and Pfizer. Dr. Miyauchi has received honoraria for lectures from Kowa Pharmaceutical, Pfizer, and Astellas Pharma. Dr. Nakagawa has received honoraria for lectures from Kowa Pharmaceutical, Pfizer, and Astellas Pharma. Dr. Yamagishi has received honoraria for lectures from Kowa Pharmaceutical, Pfizer, and Astellas Pharma and has received a research grant from Kowa Pharmaceutical and Astellas Pharma. Dr. Ozaki is an advisory member of Kowa Pharmaceutical and has received honoraria for lectures from Pfizer and Kowa Pharmaceutical. Dr. Kimura is an advisory member of Kowa Pharmaceutical and has received honoraria for the lectures from Kowa Pharmaceutical and Astellas Pharma. Dr. Saito has received honoraria for lectures from Kowa Pharmaceutical. Dr. Daida is an advisory member of Kowa Pharmaceutical and has received honoraria for lectures and research grants from Kowa Pharmaceutical, Pfizer, and Astellas Pharma. Dr. Matsuzaki is an advisory member of Kowa Pharmaceutical and Pfizer and has received honoraria for lectures and research grants from Kowa Pharmaceutical, Pfizer, and Astellas Pharma.
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).
UR - http://www.scopus.com/inward/record.url?scp=67650095320&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=67650095320&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2009.04.033
DO - 10.1016/j.jacc.2009.04.033
M3 - Article
C2 - 19608026
AN - SCOPUS:67650095320
SN - 0735-1097
VL - 54
SP - 293
EP - 302
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 4
ER -