Abstract 1697: A First-In-Man, Randomized, Placebo-Controlled Study to Evaluate the Safety and Feasibility of Autologous Delipidated High Density Lipoprotein Plasma Infusions in Patients With Acute Coronary Syndrome
Background: Increasing preβ high-density lipoprotein (HDL) has been shown to increase cholesterol efflux and is reported to be the most effective form of HDL for lipid removal from arterial plaque in reverse cholesterol transport (RCT). Plasma delipidation converts αHDL to pre-β HDL thus promoting RCT. This study aimed to test the safety and feasibility of autologous delipidated HDL infusions in acute coronary syndrome (ACS) patients and its impact on plaque volume assessed by IVUS.
Methods: Patients with ACS scheduled for cardiac catheterization with a non-obstructive atheroma in at least 1 native coronary artery were randomized to HDL delipidation or control and subjected to apheresis/reinfusion. Patients had 7 sessions each 1 week apart. Patients underwent IVUS evaluation of the target vessel during the diagnostic catheterization for ACS and up to 14 days following the final procedure.
Results: The trial is complete with 28 patients randomized. All reinfusion sessions have been well tolerated by the patients. 2-D gel electrophoresis of delipidated plasmas performed on a select group of patients demonstrated conversion of αHDL to preβ HDL. The levels of pre β HDL and αHDL in the undelipidated control versus delipidated plasma converted from 5.6% to 79.1% and 92.8% to 20.9%, respectively. Associated with the pre β HDL increase was a 5x rise in the cholesterol efflux for the delipidated plasma versus the control. The IVUS data suggests a numeric trend towards regression in atheroma volume (Table⇓). Complete safety data and IVUS analyses will be available upon presentation.
Conclusions: In patients with ACS, serial autologous infusions of HDL delipidated plasma are well tolerated by patients, and are clinically feasible. This therapy may offer a novel adjunct treatment for patients presenting with ACS, and may ultimately stabilize and regress atherosclerotic plaques.