Why the study?
Although a single-center study showed that atorvastatin regresses nonculprit coronary plaque volume in ACS, the effect of other statins on plaque volume in ACS had not been evaluated in a multicenter setting.
Does intensive lipid-lowering therapy with pitavastatin 4 mg/day result in noninferior regression of nonculprit coronary plaque volume compared with atorvastatin 20 mg/day in patients with acute coronary syndrome undergoing PCI?
RCT (n=307)
Open-label with blind end point evaluation
Randomized, parallel group
Yes
Does intensive lipid-lowering therapy with pitavastatin 4 mg/day result in noninferior regression of nonculprit coronary plaque volume compared with atorvastatin 20 mg/day in patients with acute coronary syndrome undergoing PCI?
In patients with ACS undergoing PCI, pitavastatin 4 mg/day is noninferior to atorvastatin 20 mg/day in achieving significant regression of nonculprit coronary plaque volume over 8 to 12 months.
Equivalent plaque regression with pitavastatin versus atorvastatin in ACS; leaves open generalization to other statins.
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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Hiro et al. (2009) conducted an RCT in Acute coronary syndrome (n=307). Pitavastatin vs. Atorvastatin 20 mg/day was evaluated on Percentage change in nonculprit coronary plaque volume (PV) (MD 1.11%, 95% CI -2.27 to 4.48, p=0.5).
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