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CLINICAL RESEARCH: CLINICAL TRIAL

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

Ron Waksman, MD^_*,_*, Rebecca Torguson, MPH^_*, Kenneth M. Kent, MD, PhD^_*, Augusto D. Pichard, MD^_*, William O. Suddath, MD^_*, Lowell F. Satler, MD^_*, Brenda D. Martin, RN^_*, Timothy J. Perlman, BSME, Jo-Ann B. Maltais, PhD, Neil J. Weissman, MD^_*, Peter J. Fitzgerald, MD and H. Bryan Brewer, Jr, MD^_*,

^_* Department of Internal Medicine, Division of Cardiology, Washington Hospital Center, Washington, DC
Lipid Sciences, Inc., Pleasanton, California
IVUS Core Laboratory, Division of Cardiology, Stanford University, Palo Alto, California

Manuscript received September 24, 2009; revised manuscript received December 16, 2009, accepted December 17, 2009.

^_* Reprint requests and correspondence: Dr. Ron Waksman, Washington Hospital Center, 110 Irving Street NW, Suite 4B-1, Washington, DC 20010 (Email: ron.waksman{at}medstar.net).

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 HDL 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 HDL 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 HDL 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 mm³ in the delipidated group versus an increase of total atheroma volume of 2.80 ± 21.25 mm³ 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.

Key Words: HDL delipidation • atheroma volume regression • acute coronary syndrome

Abbreviations and Acronyms   ACS = acute coronary syndrome   CVD = cardiovascular disease   EEM = external elastic membrane   HDL = high-density lipoprotein   HDL-C = high-density lipoprotein cholesterol   IVUS = intravascular ultrasound   LDL = low-density lipoprotein   LDL-C = low-density lipoprotein cholesterol

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