Effects of lowest-dose vs. highest-dose pitavastatin on coronary neointimal hyperplasia at 12-month follow-up in type 2 diabetic patients with non-ST elevation acute coronary syndrome: an optical coherence tomography analysis

Abstract

Current ACC/AHA guidelines recommend high-dose statin therapy after coronary stenting, especially in diabetic patients; however, pitavastatin 4mg or pitavastatin 1mg are frequently used after coronary stenting in Asia, even in patients with acute coronary syndrome. We compared the effects of highest-dose and lowest-dose pitavastatin therapy on coronary neointimal hyperplasia at 12-month follow-up in diabetic patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) using optical coherence tomography. A total of 72 diabetic patients with NSTE-ACS were randomized to lowest-dose pitavastatin [1mg (n=36)] or highest-dose pitavastatin [4mg (n=36)] after everolimus-eluting stent implantation. The primary endpoint was to compare the normalized neointimal volume at 12-month follow-up. Normalized neointimal volume was significantly lower in the pitavastatin 4mg group (4.002.80 vs. 8.24 +/- 2.83mm(3)/mm, p<0.01) at 12-month follow-up. There was also significant difference in neointimal area between the pitavastatin 4mg group and pitavastatin 1mg group (0.41 +/- 0.28 vs. 0.74 +/- 0.23mm(2), p<0.01). Improvement of brachial artery flow-mediated dilation (baFMD) was significantly higher in the pitavastatin 4mg group than in pitavastatin 1mg group (0.15 +/- 0.15 vs. -0.03 +/- 0.19mm, p<0.001). In addition, the improvement of adiponectin levels was significantly greater in the pitavastatin 4mg group than in the pitavastatin 1mg group (2.97 +/- 3.98 vs. 0.59 +/- 2.80g/mL, p<0.05). Pitavastatin 4mg significantly improved inflammatory cytokines and lipid profiles compared to pitavastatin 1mg during the 12-month follow-up, contributing to the reduction of neointimal hyperplasia and to the improvement of baFMD in diabetic patients with NSTE-ACS requiring coronary stenting. Thus, the administration of pitavastatin 4mg can be safely and effectively used in high-risk patients requiring coronary stenting. Trial registration NCT02545231 (Clinical Trial registration information: https://clinicaltrials.gov/ct2/show/NCT02545231)