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.
OBJECTIVE
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 alphaHDL to prebeta-like HDL, the most effective form of HDL for lipid removal from arterial plaques.


METHODS
ACS patients undergoing cardiac catheterization with >or=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 alphaHDL to prebeta-like HDL. The trial was complete with 28 patients randomized.


RESULTS
All reinfusion sessions were tolerated well by all patients. The levels of prebeta-like HDL and alphaHDL 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 mm(3) in the delipidated group versus an increase of total atheroma volume of 2.80 +/- 21.25 mm(3) in 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.
Waksman
Ron
R
Department of Internal Medicine, Division of Cardiology, Washington Hospital Center, Washington, DC 20010, USA. ron.waksman@medstar.net
Torguson
Rebecca
R
Kent
Kenneth M
KM
Pichard
Augusto D
AD
Suddath
William O
WO
Satler
Lowell F
LF
Martin
Brenda D
BD
Perlman
Timothy J
TJ
Maltais
Jo-Ann B
JA
Weissman
Neil J
NJ
Fitzgerald
Peter J
PJ
Brewer
H Bryan
HB
D054058:Acute Coronary Syndrome / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D000328:Adult; D000368:Aged; D016913:Blood Component Transfusion / Q000379:methods*; D001804:Blood Transfusion, Autologous; D015180:Electrophoresis, Gel, Two-Dimensional; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008075:Lipoproteins, HDL / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D008075:Lipoproteins, HDL