Introduction
Materials and methods
Study population and study design
Study device
Procedure
Follow-up
Endpoints
Quantitative angiography analysis
Optical coherent tomography analysis
Statistical analysis
Results
Baseline clinical and angiographic characteristics
Baseline clinical characteristics | BiOSS LIM®
| Prolim®
| Alex®
| P |
---|---|---|---|---|
n = 11 (%) | n = 29 (%) | n = 16 (%) | ||
Age (years) | 60 ± 6 | 68 ± 10 | 62 ± 9 | 0.03* |
Women | 3 (27) | 9 (31.0) | 4 (25) | 0.96 |
Hypertension | 8 (72.7) | 25 (86.2) | 12 (75) | 0.63 |
Hypercholesterolemia | 11 (100) | 24 (82.8) | 9 (56.3) | 0.13 |
Diabetes type 2 | 3 (27.3) | 9 (31.0) | 7 (43.8) | 0.65 |
Prior MI | 6 (54.5) | 7 (24.1) | 9 (56.3) | 0.11 |
Prior PCI | 3 (27.3) | 8 (27.6) | 6 (37.5) | 0.79 |
CABG | 0 | 2 (6.7) | 0 | 0.9 |
Chronic kidney disease | 0 | 3 (10.3) | 0 | 0.8 |
Clinical indication for PCI | ||||
Planned PCI | 11 (100) | 19 (65.5) | 10 (62.5) | 0.10 |
UA | 0 | 6 (20.7) | 6 (37.5) | 0.24 |
NSTEMI | 0 | 4 (13.8) | 0 | 0.67 |
STEMI | 0 | 0 | 0 | 0.99 |
Baseline angiographic characteristics | BIOSS LIM®
| Prolim®
| Alex®
| P |
---|---|---|---|---|
n = 11 (%) | n = 29 (%) | n = 16 (%) | ||
Multivessel disease | 7 (63.6) | 18 (62.1) | 0 | 0.0014**,*** |
Lesion type | ||||
A | 0 | 9 (31.0) | 0 | 0.13 |
B1 (27.3) | 3 (27.3) | 17 (58.6) | 5 (31.3) | 0.15 |
B2 (54.5) | 6 (54.5) | 2 (6.9) | 7 (43.8) | 0.027*,** |
C | 2 (18.2) | 1 (3.5) | 4 (25) | 0.45 |
Lesion location | ||||
LM | 0 | 0 | 0 | 0.98 |
LAD | 8 (72.7) | 14 (48.3) | 6 (37.5) | 0.31 |
LCx | 3 (27.3) | 5 (17.2) | 7 (43.8) | 0.31 |
RCA | 0 | 10 (34.5) | 3 (18.8) | 0.23 |
Bifurcation lesions | ||||
Side branch > 2 mm | 10 (90.9) | 4 (13.8) | 7 (43.8) | 0.0006*,**,*** |
Side branch < 2 mm | 1 (9.1) | 5 (17.2) | NA | 0.25 |
None | 0 | 20 (68.9) | 9 (56.2) | 0.005*,*** |
Vessel tortuosity | ||||
None—mild | 7 (63.6) | 17 (58.6) | 9 (56.2) | 0.84 |
Moderate—severe | 4 (36.4) | 12 (41.4) | 7 (43.8) | 0.91 |
Calcification | ||||
None—mild | 8 (72.7) | 20 (68.9) | 13 (81.2) | 0.87 |
Moderate—severe | 3 (27.3) | 9 (31.1) | 3 (18.8) | 0.85 |
Procedural characteristics
Procedural characteristics | BIOSS LIM®
| Prolim®
| Alex®
| P |
---|---|---|---|---|
n = 11 (%) | n = 29 (%) | n = 16 (%) | ||
Device success | 11 (100) | 29 (100) | 16 (100) | 0.98 |
Predilatation | 5 (45.5) | 17 (58.6) | 4 (25) | 0.16 |
Postdilatation | 2 (18.2) | 8 (27.6) | 4 (25) | 0.90 |
Nominal stent diameter (mm) | 3.57 ± 0.12 × 3.0 ± 0.05 | 3.25 ± 0.42 | 3.25 ± 0.35 | 0.7 |
Nominal stent length (mm) | 17.45 ± 1.21 | 13.67 ± 2.88 | 16.41 ± 5.95 | 0.04* |
Stent maximal inflation pressure (atm) | 13.34 ± 1.98 | 15.33 ± 2.24 | 14.5 ± 1.8 | 0.56 |
Balloon to artery ratio | 1.11 ± 0.05 | 1.09 ± 0.08 | 1.08 ± 0.09 | 0.87 |
Additional stent implantation due to dissection | 0 | 0 | 0 | 0.98 |
Additional stent implantation due to lesion length | 0 | 0 | 0 | 0.98 |
Clinical outcomes
Quantitative coronary angiography and optical coherence tomography analysis
Parameter | BiOSS LIM®
| Prolim®
| Alex®
| |||
---|---|---|---|---|---|---|
n = 11 (%) | n = 29 (%) | n = 16 (%) | ||||
MV | MB | Mean | ||||
Pre stenting | ||||||
Lesion length (mm) | 15.86 ± 2.65 | 14.47 ± 1.84 | 11.75 ± 3.29 | 0.001**,*** | ||
RVD (mm) | 3.69 ± 0.16 | 3.0 ± 0.13 | 3.35 ± 0.14 | 3.39 ± 0.24 | 2.93 ± 0.34 | p < 0.01**,*** |
MV—%DS | 53.1 ± 9.7 | 44.8 ± 12.1 | 48.9 ± 10.9 | 64.6 ± 15.3 | 61.6 ± 11.4 | 0.0002**,**** |
MLD (mm) | 1.73 ± 0.27 | 1.65 ± 0.14 | 1.69 ± 0.2 | 1.21 ± 0.34 | 1.11 ± 0.32 | 0.00008*,*** |
Post stenting | ||||||
RVD (mm) | 3.68 ± 0.19 | 3.02 ± 0.08 | 3.35 ± 0.14 | 3.41 ± 0.23 | 3.06 ± 0.4 | p < 0.01**,*** |
MV—%DS | 9.4 ± 4.3 | 8.8 ± 3.4 | 9.1 ± 7.7 | 9.6 ± 4.1 | 5.31 ± 4.33 | 0.02** |
MLD (mm) | 3.33 ± 0.17 | 2.75 ± 0.1 | 3.04 ± 0.14 | 3.08 ± 0.28 | 2.89 ± 0.4 | 0.03** |
ALG (mm) | 1.6 ± 0.3 | 1.1 ± 0.16 | 1.35 ± 0.23 | 1.86 ± 0.39 | 1.78 ± 0.47 | 0.001*,*** |
Follow-up | ||||||
RVD (mm) | 3.63 ± 0.25 | 2.96 ± 0.09 | 3.29 ± 0.17 | 3.45 ± 0.25 | 2.98 ± 0.45 | p < 0.01**,*** |
MV—%DS | 18.2 ± 4.3 | 20.3 ± 7.4 | 19.3 ± 11.7 | 18.3 ± 6 | 12.69 ± 17.99 | p = 0.08 |
MLD (mm) | 2.97 ± 0.25 | 2.36 ± 0.22 | 2.67 ± 0.23 | 2.82 ± 0.37 | 2.61 ± 0.69 | p = 0.03** |
LLL (mm) | 0.36 ± 0.25 | 0.39 ± 0.13 | 0.38 ± 0.19 | 0.26 ± 0.17 | 0.28 ± 0.47 | p = 0.02* |
Stent type | BiOSS LIM®
| Prolim®
| Alex®
| |
---|---|---|---|---|
Parameter | n = 11 (%) | n = 29 (%) | n = 16 (%) | |
Stent apposition | ||||
Embedded | 95.8 | 98.6 | 99.2 | 0.00001*,*** |
Protruding | 2.5 | 1.2 | 0.8 | 0.0054*,*** |
Uncovered | 1.3 | 0.07 | 0.02 | 0.002*,*** |
Malapposed | 0.4 | 0.1 | 0 | 0.45 |
OCT parameters | ||||
Mean minimal lumen area (mm2) | 3.72 ± 0.57 | 4.82 ± 1.41 | 5.22 ± 1.95 | 0.027*** |
Mean lumen area (mm2) | 5.76 ± 0.73 | 6.21 ± 1.10 | 6.46 ± 1.8 | 0.35 |
Mean stent area (mm2) | 8.31 ± 0.4 | 8.39 ± 2.26 | 7.94 ± 1.84 | 0.7 |
Mean neointima area (mm2) | 2.55 ± 0.41 | 2.17 ± 0.37 | 1.49 ± 0.60 | 0.012*,*** |
Neointima volume (mm3) | 44.9 ± 4.9 | 28.16 ± 15.10 | 24.51 ± 17.64 | 0.0008*,*** |
Mean neointima burden (%) | 30.9 ± 6.2 | 24.6 ± 8.6 | 19.27 ± 8.11 | 0.0009*** |
Neoatherosclerosis assessment | ||||
Type I (thin cap, lipid-rich) | 1 (9.1) | 1 (3.4) | 0 | 0.92 |
Type II (thick cap, layered) | 2 (18.2) | 4 (13.8) | 2 (12.5) | 0.97 |
Type III (peristrut, homogenous) | 6 (54.5) | 10 (34.5) | 3 (18.8) | 0.25 |
Type IV (preexisting, homogenous) | 2 (18.2) | 14 (48.3) | 11 (68.7) | 0.09 |
Variate | Linear regression coefficient, 95% CI, p | |
---|---|---|
Univariate analysis | Multivariate analysis | |
Strut width | 1.082 (− 0.706 to 2.870), p = 0.23 | 1.632 (− 0.488 to 3.753), p = 0.13 |
Strut thickness | 0.443 (− 3.044 to 3.930), p = 0.80 | − 1.568 (− 5.935 to 2.799), p = 0.47 |
Strut cross-sectional area | 1.381 (0.403–5.212), p = 0.16 | 2.111 (1.444–2.993), p = 0.03 |
Stent diameter | − 0.174 (− 0.432 to 0.084), p = 0.18 | − 0.225 (− 0.490 to 0.039), p = 0.09 |
Stent length | − 0.021 (− 0.040 to − 0.002), p = 0.03 | − 0.025 (− 0.046 to − 0.004), p = 0.02 |
Predilatation | 0.092 (− 0.052 to 0.237), p = 0.21 | 0.111 (− 0.044 to 0.265), p = 0.16 |
Postdilatation | − 0.000 (− 0.160 to 0.159), p = 0.97 | − 0.067 (− 0.226 to 0.092), p = 0.40 |
Diabetes | 0.003 (− 0.152 to 0.158), p = 0.97 | 0.037 (− 0.136 to 0.209), p = 0.67 |
Arterial hypertension | − 0.073 (− 0.256 to 0.111), p = 0.43 | − 0.100 (− 0.354 to 0.153), p = 0.43 |
Dyslipidemia | − 0.019 (− 0.198 to 0.159), p = 0.83 | 0.025 (− 0.254 to 0.305), p = 0.86 |
Variate | Linear regression coefficient, 95% CI, p | |
---|---|---|
Univariate analysis | Multivariate analysis | |
Strut width | 87.676 (30.305 to 145.048), p = 0.003 | 66.406 (− 1.957 to 134.768), p = 0.04 |
Strut thickness | 151.185 (38.862 to 263.508), p = 0.009 | 68.154 (− 72.634 to 208.942), p = 0.34 |
Strut cross-sectional area | 90.452 (45.211–134.749), p = 0.001 | 87.198 (3.334–147.348), p = 0.01 |
Stent diameter | − 3.712 (− 12.657 to 5.233), p = 0.41 | − 7.757 (− 16.276 to 0.762), p = 0.07 |
Stent length | − 0.348 (− 1.030 to 0.334), p = 0.31 | − 0.466 (− 1.135 to 0.202), p = 0.17 |
Predilatation | 2.750 (− 2.240 to 7.741), p = 0.27 | 1.725 (− 3.254 to 6.704), p = 0.49 |
Postdilatation | − 2.069 (− 7.513 to 3.376), p = 0.45 | − 4.860 (− 9.982 to 0.263), p = 0.04 |
Diabetes | − 0.669 (− 5.982 to 4.644), p = 0.80 | − 0.416 (− 5.985 to 5.153), p = 0.88 |
Arterial hypertension | − 0.553 (− 6.887 to 5.780), p = 0.86 | − 4.343 (− 12.510 to 3.825), p = 0.29 |
Dyslipidemia | 4.950 (− 1.033 to 10.934), p = 0.10 | 5.426 (− 3.581 to 14.432), p = 0.23 |