PED Flex | PED Shield | Solitaire | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Implanted stents, n | 6 | 6 | 4 | |||||||||
Thrombosed stents on day 7, n | 6 | 2 | 0 | |||||||||
Position-based analysis | n=18 | n=18 | n=12 | |||||||||
Day 0 | Day 7 | Day 14 | Day 21 | Day 0 | Day 7 | Day 14 | Day 21 | Day 0 | Day 7 | Day 14 | Day 21 | |
Lumen area, mm2* | 16.53±2.12 | 9.67±3.50 | 11.12±4.12 | 10.09±3.87 | 15.68±1.02 | 10.01±2.73 | 9.15±3.98 | 8.99±4.01 | 12.68±4.78 | 8.47±3.88 | 8.69±2.38 | 8.82±2.53 |
Mean diameter, mm* | 4.57±0.31 | 3.42±0.65 | 3.69±0.72 | 3.52±0.69 | 4.47±0.15 | 3.52±0.52 | 3.33±0.68 | 3.31±0.76 | 3.94±0.78 | 3.21±0.71 | 3.30±0.43 | 3.07±0.93 |
Stent area, mm2 | 15.95±1.99 | 13.51±3.55 | 13.38±4.1 | 12.13±4.54 | 12.12±2.80 | 12.12±2.80 | 11.42±4.86 | 11.71±5.58 | 8.86±3.74 | 8.87±3.74 | 9.23±1.88 | 9.30±1.79 |
Mean diameter, mm | 4.50±0.29 | 3.89±0.92 | 4.08±0.63 | 3.86±0.74 | 4.38±0.18 | 3.90±0.43 | 3.74±0.76 | 3.76±0.91 | 3.79±0.65 | 3.29±0.67 | 3.41±0.35 | 3.42±0.34 |
Neointima, mm2 (stent − lumen) | 3.84±3.02 | 2.26±1.37 | 2.04±1.73 | 2.11±3.36 | 2.26±2.23 | 2.72±2.06 | 0.40±0.39 | 0.54±0.93 | 0.48±1.22 | |||
Neointimal ratio ([stent − lumen]/stent) | 0.16±0.11 | 0.21±0.096 | 0.064±0.12 | |||||||||
Neointimal thickness minimum, mm | 0.039±0.04 | 0.077±0.071 | 0.0042±0.012 | |||||||||
Neointimal thickness maximum, mm | 0.39±0.31 | 0.45±0.33 | 0.26±0.16 | |||||||||
Thickness ratio (min/max) | 0.1±0.12 | 0.21±0.17 | 0.022±0.068 | |||||||||
Detected neointima in every position, % | 27.8 | 68.8 | 100.0 | 47.1 | 80.0 | 100.0 | 8.3 | 83.3 | 100.0 | |||
Distal position, % | 33.3 | 80.0 | 100.0 | 50.0 | 100.0 | 100.0 | 0.0 | 75.0 | 100.0 | |||
Middle position, % | 16.7 | 50.0 | 100.0 | 33.3 | 80.0 | 100.0 | 25.0 | 75.0 | 100.0 | |||
Proximal position, % | 33.3 | 80.0 | 100.0 | 60.0 | 60.0 | 100.0 | 0.0 | 100.0 | 100.0 |
Data are reported as mean±SD.
*p<0.05 PED Flex vs Solitaire stent.
OCT, optical coherence tomography; PED, Pipeline Flex embolization device.