Study Design: Double-blind, randomized, placebo-controlled multicenter pilot trial comparing the effect of intravenous recombinant apo A-IMilano/phospholipid complexes (ETC-216) or placebo on coronary atheroma burden as measured by intravascular

1
Effect of Recombinant Apo A-IMilano on Coronary
Atherosclerosis in Patients with Acute Coronary
Syndrome

• Study Design Double-blind, randomized,
  placebo-controlled multicenter pilot trial
  comparing the effect of intravenous recombinant
  apo A-IMilano/phospholipid complexes (ETC-216) or
  placebo on coronary atheroma burden as measured
  by intravascular ultrasound (IVUS)
• Intervention 123 patients screened, 59
  randomized, and 47 completed protocol in ratio
  of 122, patients received 5 weekly infusions of
  placebo or ETC-216 at 15 mg/kg or 45 mg/kg
  atheroma burden was measured by IVUS at baseline
  and end of 5 weeks
• Results Mean percent atheroma volume decreased
  by 1.06 in combined ETC-216 group (p.02)
  absolute reduction in atheroma volume in combined
  ETC-216 groups was 14.1 mm3, or 4.2 decrease
  from baseline (plt.001).

Nissen SE et al. JAMA 200329022922300.
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Baseline Lipids and Atherosclerosis
ETC-216 ETC-216
Placebo (n12) 15 mg/kg (n23) 45 mg/kg (n22)
LDL-C 118 25 122 50 112 32
HDL-C 46 7 38 10 45 7
TG 212 153 143 83 150 77
Statin use 4 (33) 9 (39) 12 (55)
IVUS
Atheroma volume, 34.8 8.4 39.7 7.0 37.9 7.8
Total atheroma volume, mm3 173 113 296 167 231 157
Mean maximum plaque thickness, mm 0.65 0.32 0.82 0.19 0.74 0.28
Mean angiographic lumen diameter, mm 2.28 0.63 2.41 0.42 2.37 0.34
Data from 4, 11, and 4 patients of the
respective groups Data from 10, 19, and 15
patients of the respective groups
Nissen SE et al. JAMA 200329022922300.
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Effect of Recombinant Apo A-IMilano (ETC-216) on
Change in Percent Atheroma Volume
Mean
Median
Change from Baseline,
0.14
0.03
0.34
0.73
0.81
1.06
1.14
1.29
Placebo
15 mg/kg
45 mg/kg
Combined
p.03
p.02 (1 endpoint)
Nissen SE et al. JAMA 200329022922300.
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Effect of Recombinant Apo A-IMilano (ETC-216) on
Change in Total Atheroma Volume
Mean
Median
Change from Baseline, mm3
0.2
2.9
12.0
12.6
15.0
13.3
15.1
14.1
Placebo
15 mg/kg
45 mg/kg
Combined
p.02
p.007
plt.001 (2 endpoint)
Nissen SE et al. JAMA 200329022922300.