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Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled
Jean-Claude Tardif1, Jean Grégoire, Philippe L L'Allier
1Montreal Heart Institute and the Montreal Heart Institute Coordinating Center, Université de Montréal, Montreal, Quebec, Canada. jean-claude.tardif@icm-mhi.org
Insights
Reconstituted high-density lipoprotein (HDL) infusions did not significantly reduce coronary plaque volume but improved plaque characterization and coronary score. Further studies on HDL infusions for vascular disease are warranted.
Area of Science:
- Cardiology
- Vascular Biology
- Pharmacology
Background:
- High-density lipoprotein (HDL) cholesterol is inversely associated with coronary atherosclerotic disease.
- Preliminary studies suggest HDL infusions may promote atherosclerosis regression.
Purpose of the Study:
- To evaluate the impact of reconstituted HDL infusions on coronary plaque burden.
- To assess changes in atheroma volume using intravascular ultrasound (IVUS).
Main Methods:
- A randomized, placebo-controlled trial involving 145 patients with evaluable serial IVUS examinations.
- Patients received 4 weekly infusions of placebo or reconstituted HDL (CSL-111) at 40 mg/kg.
- Primary endpoint was the percentage change in atheroma volume; secondary endpoints included plaque volume and characterization.
Main Results:
- No significant difference in atheroma volume change between CSL-111 and placebo groups.
- Statistically significant improvements in plaque characterization index (IVUS) and coronary score (QCA) were observed with CSL-111.
- The 80 mg/kg CSL-111 group was discontinued due to liver abnormalities; the 40 mg/kg dose was generally well-tolerated with mild transaminase elevations.
Conclusions:
- Short-term reconstituted HDL infusions did not significantly reduce coronary plaque volume compared to placebo.
- HDL infusions demonstrated potential benefits in improving plaque characteristics and coronary scores.
- Targeting HDL remains a promising strategy for vascular disease, warranting further clinical trials.
Context:
High-density lipoprotein (HDL) cholesterol is an inverse predictor of coronary atherosclerotic disease. Preliminary data have suggested that HDL infusions can induce atherosclerosis regression.
Objective:
To investigate the effects of reconstituted HDL on plaque burden as assessed by intravascular ultrasound (IVUS).
Design And Setting:
A randomized placebo-controlled trial was conducted at 17 centers in Canada. Intravascular ultrasound was performed to assess coronary atheroma at baseline and 2 to 3 weeks after the last study infusion.
Patients:
Between July 2005 and October 2006, 183 patients had a baseline IVUS examination and of those, 145 had evaluable serial IVUS examinations after 6 weeks.
Intervention:
Sixty patients were randomly assigned to receive 4 weekly infusions of placebo (saline), 111 to receive 40 mg/kg of reconstituted HDL (CSL-111); and 12 to receive 80 mg/kg of CSL-111.
Main Outcome Measures:
The primary efficacy parameter was the percentage change in atheroma volume. Nominal changes in plaque volume and plaque characterization index on IVUS and coronary score on quantitative coronary angiography were also prespecified end points.
Results:
The higher-dosage CSL-111 treatment group was discontinued early because of liver function test abnormalities. The percentage change in atheroma volume was -3.4% with CSL-111 and -1.6% for placebo (P = .48 between groups, P<.001 vs baseline for CSL-111). The nominal change in plaque volume was -5.3 mm3 with CSL-111 and -2.3 mm3 with placebo (P = .39 between groups, P<.001 vs baseline for CSL-111). The mean changes in plaque characterization index on IVUS (-0.0097 for CSL-111 and 0.0128 with placebo) and mean changes in coronary score (-0.039 mm for CSL-111 and -0.071 mm with placebo) on quantitative coronary angiography were significantly different between groups (P = .01 and P =.03, respectively). Administration of CSL-111 40 mg/kg was associated with mild, self-limiting transaminase elevation but was clinically well tolerated.
Conclusions:
Short-term infusions of reconstituted HDL resulted in no significant reductions in percentage change in atheroma volume or nominal change in plaque volume compared with placebo but did result in statistically significant improvement in the plaque characterization index and coronary score on quantitative coronary angiography. Elevation of HDL remains a valid target in vascular disease and further studies of HDL infusions, including trials with clinical end points, appear warranted.
Trial Registration:
clinicaltrials.gov Identifier: NCT00225719
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