Impact of Dual Lipid-Lowering Strategy With Ezetimibe and Atorvastatin on Coronary Plaque Regression in Patients With Percutaneous Coronary Intervention: The Multicenter Randomized Controlled PRECISE-IVUS Trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 26227186 · doi:10.1016/j.jacc.2015.05.065
What was done
In a prospective, multicenter randomized controlled trial (PRECISE-IVUS), Japanese patients who underwent percutaneous coronary intervention (PCI) were randomly assigned to either atorvastatin monotherapy or atorvastatin plus ezetimibe (10 mg daily), with atorvastatin uptitrated to an LDL-C target <70 mg/dl. Coronary plaque response was quantified using serial volumetric intravascular ultrasound (IVUS) at baseline and at 9 to 12 months in 202 patients.
What was found
Atorvastatin plus ezetimibe achieved lower LDL-C levels than atorvastatin monotherapy (63.2 ± 16.3 mg/dl vs. 73.3 ± 20.3 mg/dl; p < 0.001). Absolute change in percent atheroma volume (PAV) showed superiority for dual therapy (-1.4%; 95% CI: -3.4% to -0.1%) compared with monotherapy (-0.3%; 95% CI: -1.9% to 0.9%; p = 0.001), with a between-group mean difference of -1.538% (95% CI: -3.079% to 0.003%). Plaque regression based on PAV occurred in significantly more dual-therapy patients than monotherapy patients (78% vs. 58%; p = 0.004). Both arms had low rates of laboratory abnormalities and cardiovascular events.
Why it matters
Adding ezetimibe to statin therapy enhances coronary atheroma regression compared to statin monotherapy alone in post-PCI patients, supporting aggressive dual-mechanism lipid lowering.
Limits
The study assessed an imaging surrogate endpoint (IVUS plaque volume) over 9 to 12 months rather than hard clinical cardiovascular outcomes. The sample size was modest (n = 202 with serial IVUS), and the cohort was restricted to Japanese patients, which may limit generalizability to other populations.
Cited by
- supports Japanese studies have demonstrated that combining very low-dose rosuvastatin (2.5 mg or 5 mg) with ezetimibe leads to arterial plaque regression.