OBJECTIVES: The aim of the present study was to assess the effect of early statin therapy on fibrous-cap thickness in coronary plaques of patients with acute coronary syndrome (ACS) by using optical coherence tomography. BACKGROUND: Statins can contribute to the stabilization of coronary plaques. METHODS: This is a prospective, randomized, active-controlled, single-center study. Patients with ACS and untreated dyslipidemia were enrolled and randomly allocated (ratio 1:1) to either the early statin group (received pitavastatin 4 mg/day from baseline) or the late statin group (received pitavastatin 4 mg/day from 3 weeks after the baseline). Optical coherence tomography was performed at baseline, 3-week, and 36-week follow-up to assess nonculprit coronary plaques in 53 patients. RESULTS: Between baseline and 3-week follow-up, fibrous-cap thickness increased in the early statin group (140 μm [interquartile range (IQR):120 to 170 μm] to 160 μm [IQR: 130 to 190 μm]; p = 0.017), but decreased in the late statin group (135 μm [IQR: 110 to 183 μm] to 130 μm [IQR: 108 to 160 μm]; p = 0.020). The percentage of increase in fibrous-cap thickness between baseline and 3-week follow-up was significantly greater in the early statin group compared with the late statin group (8.3% [IQR: 0.0% to 21.4%] vs. -5.8% [IQR: -16.0% to 0.0%]; p < 0.001). Between baseline and 36-week follow-up, fibrous-cap thickness increased comparably in the 2 groups. CONCLUSIONS: Early therapy with pitavastatin 4 mg/day for patients with ACS provided an increase in fibrous-cap thickness in coronary plaques during the first 3 weeks of follow-up and a further increase during 36 weeks of follow-up. The study was registered with UMIN Clinical Trial Registry (Effect of PitavaStatin on Coronary Fibrous-cap Thickness-Assessment by Fourier-Domain Optical CoheRence Tomography [ESCORT]; UMIN000002678).
RCT Entities:
OBJECTIVES: The aim of the present study was to assess the effect of early statin therapy on fibrous-cap thickness in coronary plaques of patients with acute coronary syndrome (ACS) by using optical coherence tomography. BACKGROUND: Statins can contribute to the stabilization of coronary plaques. METHODS: This is a prospective, randomized, active-controlled, single-center study. Patients with ACS and untreated dyslipidemia were enrolled and randomly allocated (ratio 1:1) to either the early statin group (received pitavastatin 4 mg/day from baseline) or the late statin group (received pitavastatin 4 mg/day from 3 weeks after the baseline). Optical coherence tomography was performed at baseline, 3-week, and 36-week follow-up to assess nonculprit coronary plaques in 53 patients. RESULTS: Between baseline and 3-week follow-up, fibrous-cap thickness increased in the early statin group (140 μm [interquartile range (IQR):120 to 170 μm] to 160 μm [IQR: 130 to 190 μm]; p = 0.017), but decreased in the late statin group (135 μm [IQR: 110 to 183 μm] to 130 μm [IQR: 108 to 160 μm]; p = 0.020). The percentage of increase in fibrous-cap thickness between baseline and 3-week follow-up was significantly greater in the early statin group compared with the late statin group (8.3% [IQR: 0.0% to 21.4%] vs. -5.8% [IQR: -16.0% to 0.0%]; p < 0.001). Between baseline and 36-week follow-up, fibrous-cap thickness increased comparably in the 2 groups. CONCLUSIONS: Early therapy with pitavastatin 4 mg/day for patients with ACS provided an increase in fibrous-cap thickness in coronary plaques during the first 3 weeks of follow-up and a further increase during 36 weeks of follow-up. The study was registered with UMIN Clinical Trial Registry (Effect of PitavaStatin on Coronary Fibrous-cap Thickness-Assessment by Fourier-Domain Optical CoheRence Tomography [ESCORT]; UMIN000002678).