Effect of Recombinant ApoA-I Milano on Coronary Atherosclerosis in Patients With Acute Coronary Syndromes
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Synonyms and Keywords: Apo A-1 Milano, ETC 216, MDCO 216
Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial
- 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).
|Start Date||November 2001|
|End Date||March 2003|
|Endpoint||Change in % atheroma volume on intravascular ultrasound (IVUS)|
|Condition||Acute coronary syndromes|
|Study Arms||3 treatment groups in a respective ratio of approximatley 1:2:2 as follows:
- A 5 week, randomized, double-blinded, multicenter, parallel-treatment randomized control trial
- Patients enrolled: 123 patients
- Patients completed the protocol: 47 patients
- 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.
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.
- 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- 2 patients were withdrawn for adverse events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). 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).
However, luminal diameter on angiography was not different when comparing follow-up to baseline or when comparing ETC-216 vs. placebo.
- 1 patient with elevated liver function tests 3 times the upper normal limit with nausea vomiting, and cholelithiasis.
- 1 patient with chills, rigors, rash, nausea, vomiting, and diaphoresis that occurred during infusion.
Although Apo A-1 Milano infusions resulted in a decrease in plaque burden, further study is required to assess efficacy, safety and cost-effectiveness.
- 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