| |
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;