NEW ORLEANS (New Orleans) - Infusions of reconstituted high-density lipoprotein (HDL) in patients with coronary artery disease result in reductions in small reductions in atheroma volume and significant positive changes in plaque characterization index, researchers report.

Results of the ERASE (Effect of Reconstituted High-Density Lipoprotein on Atherosclerosis - Safety and Efficacy) trial were presented here during a late-breaking clinical trials session at the 56th annual scientific session of the American College of Cardiology, and published simultaneously online by the Journal of the American Medical Association.

Principal investigator Dr. Jean-Claude Tardif of the University of Montreal, Canada, explained that the reconstituted HDL is an investigational compound CSL-111, under development by CSL Ltd., of Victoria, Australia. "Reconstituted HDL is like 'baby HDL', with no large load of cholesterol and so has a large capacity to pick up cholesterol particles," he said.

The trial involved 183 patients with acute coronary syndromes (ACS) and a clinical need for coronary angiography. Patients were randomized to placebo or infusions of CSL-111 within two weeks of the ACS event. Patients on active treatment received four infusions of either 40 mg/kg or 80 mg/kg of reconstituted HDL cholesterol.

The high-dose arm of the study was halted early because of liver function abnormalities, Dr. Tardif reported.

Intravascular ultrasound (IVUS) of the target artery was conducted at baseline and 2-3 weeks after the fourth infusion.

CSL-111 induced a reduction in atheroma volume of 3.4%, or 5.3 cubic millimeters, compared with a reduction of 1.6% in the placebo group. This difference did not reach statistical significance, Dr. Tardif reported.

There was a significant change in plaque characterization indices and an improvement in coronary score between CSL-111 and placebo that was seen on IVUS, he said.

"This improvement in coronary score is important, considering that this qualitative coronary angiography measurement has been used as a valid marker of atherosclerosis progression-regression in studies over the past 15 years," the ERASE investigators say.

"Both primary and secondary endpoints suggest a rapid favorable effect," Dr. Tardif told Reuters Health. "This therapy definitely deserves a trial in a larger population of patients with acute coronary syndromes," he asserted.