Effect of Recombinant ApoA-I Milano on Coronary Atherosclerosis in Patients With Acute Coronary Syndromes
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: : Rim Halaby, M.D. [2]
Synonyms and keywords: Apo A-1 Milano, ETC 216, MDCO 216
Official Title
Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial
Objective
- To study the effects of intravenous recombinant Apo A-1 Milano/phospholipid complexes (ETC-216) on arterial plaque burden in patients with acute coronary syndromes (ACS).[1]
Timeline
| Timeline | |
| Start Date | November 2001 |
| End Date | March 2003 |
| Status | Completed |
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | |
| Study Design | |
| Allocation | Randomaized |
| Endpoint | Change in % atheroma volume on intravascular ultrasound (IVUS) |
| Interventional Model | Parallel |
| Masking | Double blind |
| Study Details | |
| Primary Purpose | Treatment |
| Condition | Acute coronary syndromes |
| Intervention | Drug: ETC-216 |
| Study Arms | 3 treatment groups in a respective ratio of approximatley 1:2:2 as follows:
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| Population Size |
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Methods
- A 5 week, randomized, double-blinded, multicenter, parallel-treatment randomized control trial[1]
- Patients enrolled: 123 patients
- Patients completed the protocol: 47 patients
IVUS was done at baseline. Intravenous infusion took place weekly for 5 consecutive weeks. Two weeks after infusion, IVUS was repeated for comparison.[1]
Eligibility Criteria
Inclusion Criteria
- Age: 30-75 years
- Angiography performed within 14 days following ACS event.
- At least 20% luminal diameter stenosis by visual estimated required
- Intravascular ultrasound (IVUS) done within 14 days of ACS event.
- No more than 50% luminal narrowing in a segment that is at least 30 mm in length.
- No previous percutaneous coronary intervention (PCI)
- Other anti-lipidemic drugs permitted during the study as long as no introduction or new medication or change in dosage occurs within 6 weeks of study start or end date.
Outcomes
Primary Outcome
Change in percent atheroma volume as measured by IVUS[1]
Secondary Outcomes
Assessment of adverse events, quantitative angiographic changes, change in average maximal thickness or in total volume of atheroma,or atheroma volume change in most and least severely diseases 10-mm-long segments.[1]
Publications
Results
- 10 patients were discontinued, while another 3 elected to discontinue
- 2 patients were withdrawn for adverse events
- 5 had IVUS that could not be analyzed
There was a significant difference in atheroma volume, mean change in total atheroma volume and thickness in the ETC-216 groups (combined) showing a 3.17% difference (p=0.02, p<0.001, p<0.001 respectively).[1] This statistical significance was not seen in patients on placebo. Most regression using ETC-216 was seen in subsegments of 10 mm long that are severely diseased, in comparison to those with only mild disease (p<0.001).[1]
However, luminal diameter on angiography was not different when comparing follow-up to baseline or when comparing ETC-216 vs. placebo.[1]
Adverse events included mainly minor gastrointestinal events, headaches,arthralgias, and edema that were found in all 3 groups. Two important adverse events that required withdrawal were:
- 1 patient with elevated liver function tests 3 times the upper normal limit with nausea vomiting, and cholelithiasis.[1]
- 1 patient with chills, rigors, rash, nausea, vomiting, and diaphoresis that occurred during infusion.[1]
Conclusion
Although Apo A-1 Milano infusions resulted in a decrease in plaque burden, further study is required to assess efficacy, safety and cost-effectiveness.[1]
References
- ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 Nissen SE, Tsunoda T, Tuzcu EM; et al. (2003). "Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial". JAMA : the Journal of the American Medical Association. 290 (17): 2292–300. doi:10.1001/jama.290.17.2292. PMID 14600188. Unknown parameter
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