THE ERASE TRIAL
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Objective
To study the effects of reconstituted HDL on atheromatous plaque volume as assessed by intravascular ultrasound (IVUS).
Timeline
Start Date
July 2006
End Date
October 2006
Methods
- Patients Enrolled: 183 patients
Inclusion Criteria
- Age: 30-75 years
- Women with no child bearing potential
- Patients in need for coronary angiography with at least 1 stenosis of 20% or more on baseline coronary angiography.
Exclusion Criteria
- Patients with > 50% stenosis in left main coronary artery
- Renal insufficiency
- Liver or hepatic disease
- Uncontrolled diabetes mellitus
- Symptomatic heart failure of NYHA class III or IV
- Soybean allergy (component of CSL-111 infusion)
- History of alcohol or drug abuse
- Warfarin or heparin anticoagulation during infusion period
Study Arms
- Placebo defined as normal saline
- CSL-111 infusion at a dose of 40 mg/kg
- CSL-111 infusion at a dose of 80 mg/kg
Therapy was required to take place within 2 weeks of an acute coronary syndrome. Before infusion, baseline IVUS of target coronary artery was performed need to fulfill the following conditions:
- Proximal 4 cm needed to have a reference diameter of at least 2.5 mm
- No filling defects of thrombotic nature
- No reduced luminal diameter by 50% or more according to angiographic estimation at baseline
- No previous percutaneous coronary intervention (PCI)
- Not a previous candidate for intervention at time of the baseline characteristic. Patients received 4 weekly volume-matched infusions. Follow-up IVUS at the same target artery segment occurred 2-3 weeks after last infusion.
Effect of rHDL on Atherosclerosis - Safety and Efficacy (ERASE) was a randomized, placebo-controlled trial conducted in 17 centers across Canada. An intravascular ultrasound was performed at baseline and at 2 to 3 weeks after the last infusion of rHDL to assess plaque burden.
Results
The group with higher doses of reconstituted HDL (CSL-111) was eliminated from the study because of mild liver function test abnormalities. The results of the study are briefed below:
- Percentage change in plaque volume: -3.4% with CSL-111 and -1.6% with placebo (P= 0.48 between the groups, P< 0.001 vs baseline for CSL-111)
- Nominal change in plaque volume: -5.3% with CSL-111 and -2.3% with placebo (P= 0.39 between the groups, P< 0.001 vs baseline for CSL-111)
- Mean changes in plaque characterization on IVUS: −0.0097 for CSL-111 and 0.0128 with placebo (P = .01)
- Mean changes in coronary score on quantitative coronary angiography: −0.039 mm for CSL-111 and −0.071 mm with placebo (P= 0.03)
Conclusion
Short term infusions of reconstituted HDL (CSL-111) resulted in:
- No significant reductions in percentage plaque volume compared to placebo.
- Statistically significant improvement in mean changes in plaque characterization on IVUS and coronary score on quantitative coronary angiography, compared to placebo.[1]
References
- ↑ Tardif JC, Grégoire J, L'Allier PL; et al. (2007). "Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial". JAMA : the Journal of the American Medical Association. 297 (15): 1675–82. doi:10.1001/jama.297.15.jpc70004. PMID 17387133. Unknown parameter
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