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

ObjectivesThis study aimed to determine whether serial autologous infusions of selective high-density lipoprotein (HDL) delipidated plasma are feasible and well tolerated in patients with acute coronary syndrome (ACS).BackgroundLow HDL is associated with increased risk of cardiovascular disease. Plasma selective delipidation converts αHDL to preβ-like HDL, the most effective form of HDL for lipid removal from arterial plaques.MethodsACS patients undergoing cardiac catheterization with ≥1 nonobstructive native coronary artery atheroma were randomized to either 7 weekly HDL selective delipidated or control plasma apheresis/reinfusions. Patients underwent intravascular ultrasound (IVUS) evaluation of the target vessel during the catheterization for ACS and up to 14 days following the final apheresis/reinfusion session. 2-D gel electrophoresis of delipidated plasmas established successful conversion of αHDL to preβ-like HDL. The trial was complete with 28 patients randomized.ResultsAll reinfusion sessions were tolerated well by all patients. The levels of preβ-like HDL and αHDL in the delipidated plasma converted from 5.6% to 79.1% and 92.8% to 20.9%, respectively. The IVUS data demonstrated a numeric trend toward regression in the total atheroma volume of −12.18 ± 36.75 mm3in the delipidated group versus an increase of total atheroma volume of 2.80 ± 21.25 mm3in the control group (p = 0.268).ConclusionsIn ACS patients, serial autologous infusions of selective HDL delipidated plasma are clinically feasible and well tolerated. This therapy may offer a novel adjunct treatment for patients presenting with ACS. Further study will be needed to determine its ability to reduce clinical cardiovascular events.