Injection of a novel form of synthetic high-density lipoprotein cholesterol (HDL-C) into the arteries of patients who had recently had a myocardial infarction did not reduce the amount of plaque in the arteries when compared with placebo injections, according to research presented by the study's lead author, Stephen Nicholls, MBBS, PhD, FACC, director of the Vascular Research Centre at the South Australian Health and Medical Research Institute in Adelaide, on March 18 at the ACC.17 in Washington, DC.

In the CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial (CARAT), 301 patients with an acute coronary syndrome (ACS) and percent atheroma volume (PAV) >30 percent were randomized to ten weekly infusions of CER-001 3 mg/kg or placebo. CER-001 is a pre-beta high-density lipoprotein (HDL) mimetic containing sphingomyelin and dipalmitoyl phosphatidlyglycerol. One to three weeks after the last infusion, the participants underwent a second ultrasound examination of the same coronary artery that had previously been shown to be at least 30 percent blocked. Researchers also looked at additional measures of plaque volume, cholesterol levels, and safety and tolerability.

Results showed the primary endpoint decreased by 0.41 percent in the placebo group and by 0.09 percent in the CER-001 group, a non-statistically significant difference. Analysis of the major secondary endpoints revealed a reduction in total atheroma volume of 6.6 mm3 in the placebo group and 5.6 mm3 in the CER-001 group and regression of percent atheroma volume in 57.7 percent of placebo patients and 53.3 percent of CER-001 patients. Neither of these findings met the cutoff for statistical significance. Levels of LDC-C declined equally in the CER-001 and placebo groups. Rates of adverse events were low and were similar in both groups. While CER-001 was found to be well tolerated, the researchers found that it does not appear to be a promising treatment for use in patients with ACS.

"We are disappointed that low-dose CER-001 did not show a benefit in a patient population at elevated risk for an ACS event," said Nicholls. "We will continue to analyze the CARAT data in order to fully understand the study's findings, and we will continue to search for effective therapies targeting residual risk for ACS events."

Keywords: ACC17, ACC Annual Scientific Session, Acute Coronary Syndrome, Apolipoprotein A-I, Atherosclerosis, Cholesterol, Coronary Angiography, Coronary Artery Disease, Double-Blind Method, Heart Failure, High-Density Lipoproteins, Pre-beta, Kidney Diseases, Lipoproteins, HDL, Liver, Phospholipids, Plaque, Atherosclerotic, Primary Prevention, Sphingomyelins, Triglycerides

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