THE ERASE TRIAL: Difference between revisions
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===Study Arms=== | ===Study Arms=== | ||
* | *60 patients receiving placebo, defined as normal saline infusion | ||
*CSL-111 infusion at a dose of 40 mg/kg | *111 patients receiving CSL-111 infusion at a dose of 40 mg/kg | ||
*CSL-111 infusion at a dose of 80 mg/kg | *12 patients receiving 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 using 40-MHz catheters was performed and need to fulfill the following conditions: | Therapy was required to take place within 2 weeks of an acute coronary syndrome. Before infusion, baseline IVUS of target coronary artery using 40-MHz catheters was performed and need to fulfill the following conditions: | ||
| Line 46: | Line 46: | ||
Patients received 4 weekly volume-matched infusions; but infusions can be postponed for 1 week on a maximum of 2 consecutive occasions if liver transaminases were > 1.5 times the upper normal limit. | Patients received 4 weekly volume-matched infusions; but infusions can be postponed for 1 week on a maximum of 2 consecutive occasions if liver transaminases were > 1.5 times the upper normal limit. | ||
Follow-up IVUS at the same target artery segment occurred 2-3 weeks after last infusion | Follow-up IVUS at the same target artery segment occurred 2-3 weeks after last infusion: | ||
*47 patients of placebo group had baseline and follow-up IVUS | |||
*89 patients of CSL-111 40 mg/kg group had baseline and follow-up IVUS | |||
*9 patients of CSL-111 80 mg/kg group had baseline and follow-up IVUS | |||
===Outcomes=== | ===Outcomes=== | ||
Revision as of 02:51, 19 September 2013
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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
- Monitoring of adverse events, physical exam findings, ECG, and lab results were used to assess patient safety. Blood was withdrawn immediately before and 24 hours after infusion. If liver transaminases were > 5 times upper normal limit, patients withdrew blood after 3 days of infusion
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
- 60 patients receiving placebo, defined as normal saline infusion
- 111 patients receiving CSL-111 infusion at a dose of 40 mg/kg
- 12 patients receiving 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 using 40-MHz catheters was performed and 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; but infusions can be postponed for 1 week on a maximum of 2 consecutive occasions if liver transaminases were > 1.5 times the upper normal limit.
Follow-up IVUS at the same target artery segment occurred 2-3 weeks after last infusion:
- 47 patients of placebo group had baseline and follow-up IVUS
- 89 patients of CSL-111 40 mg/kg group had baseline and follow-up IVUS
- 9 patients of CSL-111 80 mg/kg group had baseline and follow-up IVUS
Outcomes
Primary Outcome
Percentage difference in volume of atheroma between follow-up and baseline on IVUS.
Secondary Outcome
Absolute change in coronary score, defined as the mean of minimal lumen diameter for all measured lesions on angiography, and change in plaque volume and characterization on IVUS
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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