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

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:
  • Placebo - 0.9% normal saline (11 patients)
  • Low-dose ETC-216 - 15 mg/kg (21 patients)
  • High-dose ETC-216 - 45 mg/kg (15 patients)
Population Size
  • Patients enrolled: 123
  • Patients randomly assigned: 57
  • Patients completed protocol: 47

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

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  • 2 patients were withdrawn for adverse events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. 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 |month= ignored (help)