A first-in-man, randomized, placebo-controlled study to evaluate the safety and feasibility of autologous delipidated high-density lipoprotein plasma infusions in …

R Waksman, R Torguson, KM Kent, AD Pichard… - Journal of the American …, 2010 - jacc.org
R Waksman, R Torguson, KM Kent, AD Pichard, WO Suddath, LF Satler, BD Martin…
Journal of the American College of Cardiology, 2010jacc.org
Objectives: This 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). Background: Low 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. Methods: ACS
patients undergoing cardiac catheterization with≥ 1 nonobstructive native coronary artery …
Objectives
This 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).
Background
Low 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.
Methods
ACS 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.
Results
All 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).
Conclusions
In 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.
jacc.org