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Ezetimibe plus statin linked to greater plaque regression in patients with PCI
Patients who underwent PCI had greater coronary plaque regression when assigned a statin plus ezetimibe compared with those assigned statin monotherapy, according to the results of the PRECISE-IVUS study.
Researchers compared the effects of ezetimibe (Zetia, Merck) plus atorvastatin on lipid profile and coronary atheroma regression with those of atorvastatin alone in Japanese patients who underwent PCI.
All patients (n = 246; 79% men) received atorvastatin uptitrated with an LDL goal of less than 70 mg/dL. They also were randomly assigned ezetimibe 10 mg/day or placebo. The groups had similar LDL levels at baseline.
The researchers performed serial volumetric IVUS to quantify coronary plaque response at baseline and at 9 to 12 months in the 202 patients for whom IVUS could be performed and was analyzable.
LDL, plaque lower
Kenichi Tsujita, MD, PhD, from the department of cardiovascular medicine, graduate school of medical sciences, Kumamoto University, Japan, and colleagues found that the ezetimibe/atorvastatin group had lower levels of LDL at 9 to 12 months compared with the atorvastatin monotherapy group (63.2 mg/dL vs. 73.3 mg/dL; P < .001).
The mean difference between the groups in absolute change to percent atheroma volume did not exceed the predefined noninferiority margin of 3% (–1.538%; 95% CI, –3.079 to 0.003), according to the researchers.
However, they found, the absolute change to percent atheroma volume indicated superiority for the ezetimibe/atorvastatin strategy (ezetimibe/atorvastatin, –1.4%; 95% CI, –3.4 to –0.1; atorvastatin alone, –0.3%; 95% CI, –1.9 to 0.9).
Seventy-eight percent of the ezetimibe/atorvastatin group exhibited coronary plaque regression compared with 58% of the atorvastatin monotherapy group (P = .004), Tsujita and colleagues wrote.
Adverse events were low in both groups, and target lesion revascularization and target vessel revascularization occurred at similar rates, according to the researchers.
Alternative explanations
In a related editorial, Filippo Crea, MD, and Giampaolo Niccoli, MD, PhD, wrote that, “Cholesterol lowering itself does not seem to explain the greater reduction of [percent atheroma volume] with combination therapy vs. monotherapy observed in the PRECISE-IVUS trial.” They added that this difference between the therapies was not likely to be due to the anti-inflammatory effect of ezetimibe because of the similar levels of C-reactive protein between the groups.
Crea and Niccoli also noted that the ratio of sterols to cholesterol decreased with combination therapy but increased with statin monotherapy, and “the campesterol-to-cholesterol ratio reduction was significantly and positively related to a reduction in [percent atheroma volume], which suggested a possible role for sterols other than cholesterol.”
Crea and Niccoli, both from the Institute of Cardiology at Catholic University of the Sacred Heart, Rome, wrote that other pleiotropic effects could also play a role, including modulation of genes related to inflammation and/or oxidative stress and inhibition of smooth muscle cell proliferation. – by Erik Swain
Disclosures: Tsujita, Crea and Niccoli report no relevant financial disclosures. Please see the full study for a list of other researchers’ relevant financial disclosures.