Impact of Dual Lipid-Lowering Strategy with Pitavastatin and Ezetimibe on Coronary Plaque Regression (PRECISE-IVUS)

The PRECISE-IVUS trial randomized 202 patients with CAD requiring PCI to pitavastatin + ezetimibe versus pitavastatin monotherapy and assessed coronary plaque volume by serial IVUS imaging at 9–12 months.

Adding ezetimibe to statin therapy produced greater LDL-C reduction (-55% vs -45% with monotherapy) and greater coronary plaque regression by IVUS — measured as percent atheroma volume change. The dual-therapy group demonstrated significantly more plaque regression (p=0.001), and achieved lower absolute LDL-C levels, consistent with the principle that greater LDL-C reduction produces greater plaque regression.

PRECISE-IVUS supports the incremental clinical value of ezetimibe as add-on therapy to statins for plaque regression — anticipating the IMPROVE-IT trial’s cardiovascular event reduction data (Cannon et al., 2015). The IVUS endpoint is a validated surrogate for plaque burden change, and IVUS-measured plaque regression is associated with reduced cardiovascular events in long-term follow-up from other IVUS outcome studies.

The Japanese patient population and moderate trial scale (n=202) limit generalizability, but the finding is mechanistically consistent with the broader lipid-lowering literature: the greater the LDL-C reduction, the greater the plaque regression achieved — regardless of which agent achieves the reduction.

We rate the evidence moderate. A randomized IVUS trial in 202 patients demonstrating that ezetimibe added to pitavastatin produces greater plaque regression than statin monotherapy — mechanistic evidence supporting combination lipid-lowering therapy for achieving maximal plaque stabilization.