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document
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 . 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 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 .
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Intervention_Control
placebo-controlled
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Intervention_Physical
autologous delipidated high-density lipoprotein plasma infusions
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Intervention_Pharmacological
serial autologous infusions of selective high-density lipoprotein ( HDL )
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Intervention_Physical
delipidated plasma
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Intervention_Physical
HDL selective delipidated
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Intervention_Control
control plasma apheresis/reinfusions
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Intervention_Physical
intravascular ultrasound
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Intervention_Pharmacological
apheresis/reinfusion
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Intervention_Pharmacological
selective HDL delipidated plasma
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Outcome_Other
safety and feasibility
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Outcome_Other
feasible
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Outcome_Other
tolerated
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Outcome_Physical
intravascular ultrasound ( IVUS ) evaluation
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Outcome_Other
tolerated
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Outcome_Physical
levels of prebeta-like HDL and alphaHDL
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Outcome_Physical
atheroma volume
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Outcome_Physical
total atheroma volume
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Outcome_Other
clinically feasible
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Outcome_Other
tolerated .
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Outcome_Physical
clinical cardiovascular events .
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Participant_Condition
acute coronary syndrome
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Participant_Condition
acute coronary syndrome
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Participant_Condition
ACS
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Participant_Condition
ACS
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Participant_Condition
undergoing cardiac catheterization
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Participant_Condition
> or=1 nonobstructive native coronary artery atheroma
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Participant_Sample-size
28
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Participant_Condition
ACS
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Participant_Condition
ACS