Table 6. Change in IVUS measures following infusion of placebo and CER-001 at different dose.
| IVUS measures | Placebo | CER-001: 3 mg/kg | CER-001: 6 mg/kg | CER-001: 12 mg/kg |
|---|---|---|---|---|
| Baseline PAV <30% | ||||
| Baseline measures | ||||
| PAV (%) | 25.3±3.7 | 26.5±2.8 | 24.5±3.5 | 24.4±3.7 |
| TAV (mm3) | 99.5±29.4 | 111.0±35.9 | 104.7±45.6 | 101.1±36.9 |
| EEM volume (mm3) | 392.2±95.9 | 416.1±125.0 | 426.2±171.0 | 413.6±131.7 |
| Lumen volume (mm3) | 292.7±72.6 | 305.0±91.1 | 321.4±129.5 | 312.5±100.2 |
| Maximum atheroma thickness (mm) | 0.53±0.13 | 0.56±0.12 | 0.51±0.16 | 0.51±0.14 |
| Serial changes | ||||
| PAV (%)* | 0.09±0.36 | 0.41±0.32 | 0.27±0.36 | 0.32±0.37 |
| TAV (mm3)* | −3.33±1.88 | −1.31±1.69 | −3.38±1.88 | −1.82±1.92 |
| EEM volume (mm3) | −11.38±39.90 | −10.05±22.16 | −20.22±37.24 | −13.25±32.77 |
| Lumen volume (mm3) | −8.37±34.30 | −8.32±17.24 | −16.82±32.49 | −11.63±26.19 |
| Maximum atheroma thickness (mm)* | −0.005±0.010 | −0.005±0.009 | −0.015±0.010 | −0.004±0.011 |
| Baseline PAV ≥30% | ||||
| Baseline measures | ||||
| PAV (%) | 40.1±7.1 | 38.6±6.7 | 40.2±6.7 | 39.8±5.8 |
| TAV (mm3) | 165.2±54.6 | 145.1±55.2 | 163.0±73.5 | 161.3±59.4 |
| EEM volume (mm3) | 409.9±114.1 | 375.2±132.1 | 402.9±153.7 | 403.0±128.7 |
| Lumen volume (mm3) | 244.6±74.0 | 230.1±85.5 | 239.8±90.6 | 241.7±80.0 |
| Maximum atheroma thickness (mm) | 0.90±0.21 | 0.82±0.18 | 0.87±0.20 | 0.88±0.21 |
| Serial changes | ||||
| PAV (%)* | −0.25±0.31 | −0.96±0.34 | −0.61±0.32 | +0.17±0.32 |
| TAV (mm3)* | −2.71±1.53 | −6.23±1.68 | −3.42±1.44 | −2.72±1.56 |
| EEM volume (mm3) | −4.46±26.34 | −7.17±15.91 | −2.70±28.29 | −7.81±32.85 |
| Lumen volume (mm3) | −1.48±20.08 | −1.57±13.14 | 0.88±20.86 | −5.00±28.20 |
| Maximum atheroma thickness (mm)* | −0.009±0.007 | −0.027±0.008 | −0.013±0.007 | −0.006±0.008 |
*, adjusted for baseline value. IVUS, intravascular ultrasound; EEM, external elastic membrane; PAV, percent atheroma volume; TAV, total atheroma volume.