Nano Group Ferro Group Stenting Control ANOVA, p value
Number of enrolled patients, no. 60 60 60 NA
Imaging and clinical follow-up (intention-to-treat population, ITTP), no. (%) 60 (100%) 60 (100%) 60 (100%) NA
Imaging and clinical follow-up (per-treatment-evaluable population, PTEP), no (%) 42 (70.0%) 34 (56.7%) 40 (66.7%) NA
Imaging post-procedure (PTEP/ ITTP populations)
Minimal lumen diameter (MLD), mm 1.16±0.54 1.19±0.42 1.29±0.44 1.37±0.69 2.26±0.84 2.42±0.62 < 0.01 < 0.01
Maximal lumen diameter, mm 1.64±0.32 1.69±0.74 1.59±0.94 1.75±1.01 3.01±0.99 3.03±0.84 0.031 0.042
Mean lumen diameter, mm 1.39±0.63 1.44±0.72 1.35±0.73 1.42±0.82 2.41±1.15 2.44±1.09 > 0.05
< 0.01#
> 0.05
< 0.01#
Per cent stenosis, % 53.2±14.8 54.8±19.3 46.1±18.4 41.6±24.9 7.5±2.9 10.3±8.4 < 0.01 < 0.01
Plaque burden (percent atheroma volume, PAV), % 60.0±18.4 59.9±17.2 59.9±15.3 60.3±16.8 54.4±26.6 54.6±29.3 > 0.05
0.031#
> 0.05
0.032#
Total plaque-media volume (total atheroma volume – TAV), mm3 142.3±62.7 144.5±59.9 147.9±62.2 148.9±82.2 178.4±51.9 179.1±63.3 0.031 0.029
Lumen volume, mm3 95.2±55.9 96.5±61.3 98.8±48.4 97.9±53.9 149.4±49.1 148.9±45.5 > 0.05
< 0.01#
> 0.05
< 0.01#
VH-IVUS:
• Dense calcium, %
• Necrotic core, %
• Fibrous, %
• Fibro-fatty, %

8.14±4.12
50.68±14.13
30.54±9.26
10.63±3.78

8.13±3.58
50.77±12.96
30.33±11.42
10.77±2.79

8.72±3.12
42.66±11.63
35.78±9.92
12.84±3.14

8.95±2.28
42.51±9.63
35.57±8.14
12.98±2.96

9.19±6.68
34.98±9.84
48.88±9.67
6.95±4.02

9.50±8.54
34.99±11.37
48.38±10.42
7.13±4.16

0.012
< 0.01
0.022
0.039

0.019
< 0.01
0.027
0.035
VH-IVUS:
• Calcium, mm2
• Necrotic core, mm2
• Fibrous, mm2
• Fibro-fatty, mm2

0.36±0.31
2.24±0.48
1.35±0.63
0.47±0.22

0.37±0.33
2.31±0.84
1.38±0.56
0.49±0.26

0.38±0.24
1.86±0.72
1.56±0.62
0.56±0.29

0.40±0.53
1.90±0.65
1.59±0.74
0.58±0.36

0.41±0.48
1.56±0.52
2.18±1.02
0.31±0.12

0.44±0.42
1.62±0.63
2.24±1.06
0.33±0.17

> 0.05
0.038
0.026
0.041

0.049
0.035
0.042
0.018
Imaging at 12-month follow-up (PTEP/ ITTP populations)
SYNTAX score 19.6±9.6 19.8±6.4 18.4±6.1 17.9±8.2 17.4±6.1 17.7±6.7 < 0.01 0.024
Minimal lumen diameter (MLD), mm 3.11±0.47 3.08±0.52 3.00±0.84 2.98±0.63 2.87±0.62 2.82±0.32 < 0.01 < 0.01
Maximal lumen diameter, mm 4.26±1.15 4.33±1.03 3.92±0.74 3.96±0.83 3.09±0.75 3.16±0.92 < 0.01 < 0.01
Mean lumen diameter, mm
• Baseline
• Ach
• NTG

4.02±0.66
4.15±0.32
4.29±0.34

4.03±0.69
4.15±0.34
4.21±0.42

3.72±0.86
3.81±0.41
3.92±0.23

3.76±0.68
3.91±0.55
3.99±0.39

2.89±0.63
2.84±0.72
2.91±0.45

2.91±0.47
2.88±0.69
2.95±0.46
> 0.05
0.018#
0.029#
< 0.01#
> 0.05
0.021#
< 0.01#
< 0.01#
Lesion length, mm 7.21±3.52 7.43±5.11 7.72±5.12 8.03±6.13 7.98±5.22 7.85±6.38 < 0.01 0.031
Binary restenosis rate
• On-site of intervention
• In-segment

1 (2.38%)
1 (2.38%)

2 (3.33%)
2 (3.33%)

2 (5.88%)
2 (5.88%)

2 (3.33%)
2 (3.33%)

5 (12.5%)
5 (12.5%)

6 (10.0%)
6 (10.0%)
> 0.05
0.041#
> 0.05
0.041#
> 0.05
0.041#
> 0.05
0.041#
Plaque burden (percent atheroma volume, PAV), % 38.4±12.6 37.8±13.9 40.7±11.8 39.4±12.8 52.4±16.6 52.9±15.8 > 0.05
0.021#
> 0.05
0.024#
Total plaque-media volume (total atheroma volume – TAV), mm3 107.5±41.5 108.2±42.2 117.9±73.7 115.6±64.0 176.1±45.5 178.0±52.6 0.033 0.029
Lumen volume, mm3 172.3±92.2 178.3±99.4 171.8±72.8 177.7±86.3 159.9±82.5 158.4±78.7 > 0.05
< 0.01#
> 0.05
< 0.01#
VH-IVUS:
• Dense calcium, %
• Necrotic core, %
• Fibrous, %
• Fibro-fatty, %

6.39±2.14
28.19±10.51
49.25±11.63
16.17±9.15

6.57±1.92
28.47±9.53
48.91±12.96
16.06±8.53

6.45±2.02
26.45±8.36
51.29±11.95
15.81±9.28

6.01±1.85
26.58±9.36
50.95±12.04
16.46±8.15

2.66±1.82
24.69±9.93
61.50±9.75
11.14±3.64

2.83±1.69
25.47±10.05
60.38±9.92
11.32±3.84

0.042
> 0.05
0.048
0.043

0.022
> 0.05
0.039
> 0.05
VH-IVUS:
• Calcium, mm2
• Necrotic core, mm2
• Fibrous, mm2
• Fibro-fatty, mm2

0.17±0.09
0.75±0.32
1.31±0.49
0.43±0.16

0.18±0.07
0.78±0.51
1.34±0.91
0.44±0.39

0.20±0.14
0.82±0.56
1.59±0.36
0.49±0.14

0.19±0.17
0.84±0.39
1.61±0.42
0.52±0.32

0.11±0.09
1.02±0.52
2.54±1.24
0.46±0.38

0.12±0.11
1.08±0.36
2.56±1.64
0.48±0.25

0.044
0.048
< 0.01
> 0.05

0.049
0.046
< 0.01
0.051
*- p-value for the difference between Nano and Ferro groups;
#- p-value for the difference between Nano and Control groups;
NA – non-available, or not applicable. Continuous variables are expressed as mean ± SD
Table 2: Angiographic and IVUS findings post-procedure and at 12-month imaging follow-up.