Introduction
Methods
Study subjects
Optical coherence tomography data acquisition
Development of embedment analysis by optical coherence tomography
Embedment analysis algorithm
Assessment of reproducibility
Statistical analysis
Results
Population characteristics
Reproducibility of quantitative measurements
No. of matched struts | Inter-observer variability | Observer A versus observer B (1st) | ICCc | ICCa | |
---|---|---|---|---|---|
Analyzable matched struts | Absolute difference [95 % CI] | ||||
Embedment ratio (%)
| |||||
Absorb BVS | 1481 | 1481 | −0.08 [−0.51–0.36] | ||
Single measures | 0.919 [0.911–0.927] | 0.919 [0.911–0.927] | |||
Average measures | 0.958 [0.954–0.962] | 0.958 [0.954–0.962] | |||
XIENCE | 1415 | 1415 | 0.14 [−0.02–0.30] | ||
Single measures | 0.998 [0.998–0.999] | 0.998 [0.998–0.999] | |||
Average measures | 0.999 [0.999–0.999] | 0.999 [0.999–0.999] | |||
Strut embedment width (mm)
| |||||
Absorb BVS | 1481 | 1112 | −0.000 [−0.002–0.002] | ||
Single measures | 0.95 [0.943–0.955] | 0.95 [0.943–0.955] | |||
Average measures | 0.974 [0.971–0.977] | 0.974 [0.971–0.977] | |||
XIENCE | 1426 | 703 | 0.001 [0.000–0.002] | ||
Single measures | 0.984 [0.981–0.986] | 0.984 [0.981–0.986] | |||
Average measures | 0.992 [0.991–0.993] | 0.992 [0.990–0.993] |
No. of matched struts | Intra-observer variability | Observer B (1st) versus observer B (2nd) | ICCc | ICCa | |
---|---|---|---|---|---|
Analyzable matched struts | Absolute difference [95 % CI] | ||||
Embedment ratio (%)
| |||||
Absorb BVS | 1481 | 1481 | −0.33 [−0.80–0.15] | ||
Single measures | 0.933 [0.926–0.939] | 0.933 [0.926–0.939] | |||
Average measures | 0.965 [0.962–0.969] | 0.965 [0.962–0.969] | |||
XIENCE | 1415 | 1415 | 0.08 [−1.09–0.27] | 0.998 [0.998–0.999] | 0.998 [0.998–0.998] |
Single measures | 0.999 [0.999–0.999] | 0.999 [0.999–0.999] | |||
Average measures | |||||
Strut embedment width (mm)
| |||||
Absorb BVS | 1481 | 1119 | 0.001 [−0.001–0.002] | ||
Single measures | 0.944 [0.937–0.95] | 0.944 [0.937–0.95] | |||
Average Measures | 0.971 [0.968–0.974] | 0.971 [0.968–0.974] | |||
XIENCE | 1426 | 705 | 0.001 [−0.000–0.001] | ||
Single measures | 0.982 [0.979–0.984] | 0.982 [0.979–0.984] | |||
Average measures | 0.991 [0.989–0.992] | 0.991 [0.989–0.992] |
Reproducibility of qualitative measurements
Observer A | Total | Inter-observer agreement (Kappa) | ||||||
---|---|---|---|---|---|---|---|---|
Embedment category | ||||||||
0 | 1 | 2 | 3 | 4 | 5 | |||
Observer B (1st)
| ||||||||
Absorb BVS | ||||||||
Embedment category | ||||||||
0 | 54 | 11 | 0 | 0 | 0 | 0 | 65 | 0.850 |
1 | 8 | 652 | 33 | 4 | 0 | 0 | 697 | |
2 | 2 | 40 | 534 | 7 | 3 | 0 | 586 | |
3 | 0 | 3 | 12 | 80 | 6 | 1 | 102 | |
4 | 0 | 0 | 2 | 3 | 19 | 1 | 25 | |
5 | 0 | 0 | 0 | 0 | 0 | 6 | 6 | |
Total | 64 | 706 | 581 | 94 | 28 | 8 | 1481 | |
XIENCE | ||||||||
Embedment category | ||||||||
0 | 33 | 0 | 0 | 0 | 0 | 0 | 33 | 0.976 |
1 | 0 | 96 | 2 | 0 | 0 | 0 | 98 | |
2 | 0 | 1 | 149 | 8 | 1 | 0 | 159 | |
3 | 0 | 0 | 2 | 145 | 3 | 1 | 151 | |
4 | 0 | 0 | 0 | 2 | 184 | 0 | 186 | |
5 | 0 | 0 | 0 | 0 | 2 | 786 | 788 | |
Total | 33 | 97 | 153 | 155 | 190 | 787 | 1415 |
Observer B (2nd) | Total | Intra-observer agreement (Kappa) | ||||||
---|---|---|---|---|---|---|---|---|
Embedment category | ||||||||
0 | 1 | 2 | 3 | 4 | 5 | |||
Observer B (1st)
| ||||||||
Absorb BVS | ||||||||
Embedment category | ||||||||
0 | 53 | 10 | 2 | 0 | 0 | 0 | 65 | 0.867 |
1 | 6 | 656 | 30 | 5 | 0 | 0 | 697 | |
2 | 1 | 31 | 543 | 9 | 2 | 0 | 586 | |
3 | 0 | 3 | 14 | 80 | 5 | 0 | 102 | |
4 | 0 | 0 | 2 | 0 | 22 | 1 | 25 | |
5 | 0 | 0 | 0 | 0 | 0 | 6 | 6 | |
Total | 60 | 700 | 591 | 94 | 29 | 7 | 1481 | |
XIENCE | ||||||||
Embedment category | ||||||||
0 | 33 | 0 | 0 | 0 | 0 | 0 | 33 | 0.98 |
1 | 0 | 97 | 1 | 0 | 0 | 0 | 98 | |
2 | 0 | 0 | 154 | 5 | 0 | 0 | 159 | |
3 | 0 | 0 | 3 | 144 | 3 | 1 | 151 | |
4 | 0 | 0 | 0 | 1 | 185 | 0 | 186 | |
5 | 0 | 0 | 0 | 0 | 4 | 784 | 788 | |
Total | 33 | 97 | 158 | 150 | 192 | 785 | 1415 |