Histomorphometric and vascular healing response analysis of stents according to the PCB formulation used at 28 days
| Crystalline coating (n=9) | Amorphous coating (n=9) | POBA control (n=8) | p Value | |
|---|---|---|---|---|
| Morphometric analysis | ||||
| EEL area (mm2) | 11.54±2.3 | 9.53±1.2 | 10.03±1.3 | 0.054 |
| IEL area (mm2) | 9.29±1.5* | 7.53±1.1 | 7.85±1.4 | 0.026 |
| Lumen area (mm2) | 4.25±1.9* | 2.15±1.4 | 2.47±2.0 | 0.046 |
| Medial area (mm2) | 2.24±1.1 | 2±0.3 | 2.17±0.6 | ns |
| Neointimal thickness (μm) | 588±232 | 750±210 | 759±283 | ns |
| Per cent area stenosis (%) | 54.8±18* | 71.8±15 | 70.4±20 | 0.05 |
| Histological analysis | ||||
| Injury score | 1.73±0.6 | 1.88±0.7 | 2.11±0.8 | ns |
| Peri-strut inflammation | 2.27±0.8 | 2.32±0.7 | 2.15±1.1 | ns |
| Adventitial inflammation | 1.44±0.7 | 1.93±0.4 | 1.79±1.1 | ns |
| Peri-strut granuloma | 2.52±0.9 | 2.74±0.6 | 2.42±1.1 | ns |
| Endothelial coverage | 2.63±0.5 | 2.85±0.4 | 3 | ns |
| Fibrin deposits | 1.15±0.7* | 0.15±0.3 | 0 | <0.01 |
| Neointima maturity | 2.41±0.5* | 2.96±0.1 | 3 | <0.01 |
| Neointima hypocellularity | 0.37±0.5 | 0.11±0.2 | 0 | ns |
| Media hypocellularity | 0 | 0.04±0.1 | 0 | ns |
*p<0.05 vs Amorphous coating and POBA.
EEL, external elastic lamina; IEL, internal elastic lamina; PCB, paclitaxel-coated balloons; POBA, plain balloon angioplasty.