Background
Methods
Patients’ enrolment and study design
Study endpoints
Percutaneous coronary intervention procedure
Angiographic and optical frequency domain imaging analysis
Statistical analysis
Role of the funding source
Results
Baseline clinical characteristics
Absorb (n = 10) | Synergy (n = 10) |
p
| |
---|---|---|---|
N (%) | N (%) | ||
Age (years) | 56.5 ± 13.6a | 61.4 ± 9.0 | 0.350 |
Male | 9 (90.0) | 7 (70.0) | 0.582 |
Treatment for hypertension | 3 (30.0) | 3 (30.0) | 1.000 |
Treatment for hypercholesterolemia | 2 (20.0) | 0 (0.0) | 0.474 |
Diabetes mellitus | 1 (10.0) | 0 (0.0) | 1.000 |
Current smoking | 5 (50.0) | 4 (40.0) | 1.000 |
MDRD clearance < 60 ml/min/1.73 m2 | 1 (10.0) | 1 (10.0) | 1.000 |
Fasting plasma glucose ≥ 7 mmol/l | 3 (30.0) | 8 (80.0) | 0.070 |
LVEF (%) | 52.5 ± 7.9 | 52.9 ± 10.3 | 0.923 |
LAD significant lesion (> 50%) | 9 (90.0) | 7 (70.0) | 0.582 |
Cx significant lesion (> 50%) | 5 (50.0) | 1 (10.0) | 0.141 |
RCA significant lesion (> 50%) | 5 (50.0) | 8 (80.0) | 0.350 |
> 1-vessel disease | 8 (80.0) | 6 (60.0) | 0.628 |
Index PCI | Absorb (n = 10) | Synergy (n = 10) |
p
|
---|---|---|---|
N (%) | N (%) | ||
Pre-dilatation | 9 (90.0) | 4 (40.0) | 0.057 |
Post-dilatation | 8 (80.0) | 1 (10.0) | 0.005 |
Vessel diameter (mm) | 3.4 ± 0.5a | 3.7 ± 0.4 | 0.118 |
Vessel < 3.5 mm | 3 (30.0) | 1 (10.0) | 0.582 |
Implanted stents | 1.000 | ||
One | 9 (90.0) | 10 (100) | |
Two | 1 (10.0) | 0 (0) | |
Stent(s) diameter | 3.3 ± 0.4 | 3.7 ± 0.4 | 0.010 |
Stent(s) < 3.5 mm | 4 (40.0) | 1 (10.0) | 0.303 |
Stent(s) length | 23.7 ± 5.2 | 21.6 ± 5.4 | 0.388 |
Procedural and quantitative angiographic characteristics
Overall (n = 20) | Absorb (n = 10) | Synergy (n = 10) |
p
| |
---|---|---|---|---|
N (%) | N (%) | N (%) | ||
Vessel | 0.141 | |||
RCA | 12 (60%) | 4 (40%) | 8 (80%) | |
LAD | 6 (30%) | 5 (50%) | 1 (10%) | |
Cx | 2 (10%) | 1 (10%) | 1 (10%) | |
QCA post implantation | ||||
Lesion length | 18.51 ± 5.19a | 16.77 ± 3.72 | 20.25 ± 6.01 | 0.137 |
Interpolated RVD | 3.05 ± 0.54 | 2.82 ± 0.49 | 3.28 ± 0.50 | 0.056 |
MLD | 2.71 ± 0.57 | 2.42 ± 0.60 | 2.99 ± 0.38 | 0.020 |
Diameter stenosis | 11.70 ± 8.37 | 15.20 ± 9.50 | 8.20 ± 5.51 | 0.059 |
QCA at follow-up | ||||
Lesion length | 18.73 ± 5.26 | 17.43 ± 3.97 | 20.02 ± 6.25 | 0.284 |
Interpolated RVD | 2.91 ± 0.52 | 2.66 ± 0.50 | 3.21 ± 0.37 | 0.020 |
MLD | 2.59 ± 0.59 | 2.22 ± 0.60 | 2.95 ± 0.26 | 0.003 |
Diameter stenosis | 13.39 ± 10.5 | 17.90 ± 11.65 | 7.75 ± 5.50 | 0.038 |
Late lumen loss | 0.05 (0.02–0.31)b | 0.11 (0.04–0.31) | 0.03 (0.00–0.07) | 0.165 |
Quantitative OCT findings at 3-month follow-up
Absorb (n = 10) | Synergy (n = 10) |
p
| |
---|---|---|---|
N (%) | N (%) | ||
ROI length (mm) | 23.28 ± 4.25a | 21.03 ± 6.39 | 0.366 |
Proximal reference lumen area (mm2) | 7.94 ± 2.89 | 11.15 ± 3.57 | 0.053 |
Distal reference lumen area (mm2) | 7.85 ± 2.96 | 9.65 ± 3.22 | 0.209 |
Minimal lumen area (mm2) | 5.07 ± 2.00 | 7.73 ± 2.12 | 0.010 |
Endoluminal neointimal | 17.46 ± 6.91 | 14.42 ± 4.72 | 0.266 |
stent/scaffold volume (mm3) | |||
Abluminal neointimal + stent/scaffold strut volume (mm3) | 44.34 ± 14.27 | 33.57 ± 10.94 | 0.074 |
Abluminal stent area (mm2) | 7.03 ± 2.04 | 9.48 ± 2.47 | 0.027 |
Endoluminal stent area (mm2) | 5.39 ± 1.87 | 8.13 ± 2.19 | 0.008 |
Malapposition volume > 0 mm3 | 2 (20%) | 3 (30%) | 1.000 |
Stent/scaffold with > 30% area stenosis | 3 (30%) | 0 (0%) | 0.211 |
% area stenosis | 18.4 + 15.8 | 7.6 ± 7.5 | 0.067 |
Neointimal thickness (mm) | 0.04 (0.03–0.05)b | 0.05 (0.04–0.06) | 0.385 |
Maximal neointimal thickness (mm) | 0.209 (0.173–0.245) | 0.220 (0.140–0.260) | 0.880 |
Maximal in-stent/scaffold obstruction (%) | 11.5 (10–13) | 11.5 (10–14) | 0.970 |
In-stent/scaffold obstruction (%) | 7.89 (6.84–9.42) | 6.98 (6.26–7.33) | 0.112 |
Neointima | |||
Homogeneous | 6 (60%) | 30 (30%) | |
Heterogeneous | 4 (40%) | 70 (70%) | 0.370 |
Disrupted stent/scaffold | 1 (10%) | 0 | 1.000 |
All patients (n = 20) | Stent diameter < 4 mma (n = 15) | |||||
---|---|---|---|---|---|---|
N (%) | N (%) |
p
| N (%) | N (%) |
p
| |
Cross-sectional analysis (number of struts) | Absorb (229) | Synergy (191) | Absorb (229) | Synergy (89) | ||
Lumen area (mm2) | 6.61 ± 2.12b | 9.48 ± 2.50 | < 0.001 | 6.61 ± 2.12 | 7.67 ± 1.67 | < 0.001 |
Adluminal stent/scaffold area (mm2) | 8.52 ± 2.15 | 11.23 ± 2.72 | < 0.001 | 8.52 ± 2.15 | 9.32 ± 1.74 | 0.002 |
Endoluminal stent/scaffold area (mm2) | 6.65 ± 2.01 | 9.72 ± 2.48 | < 0.001 | 6.65 ± 2.01 | 8.00 ± 1.60 | < 0.001 |
Endoluminal neointimal area (mm2) | 0.76 ± 0.29 | 0.76 ± 0.25 | 0.789 | 0.76 ± 0.29 | 0.73 ± 0.20 | 0.336 |
Abluminal neointimal area + stent/scaffold strut area (mm2) | 1.94 ± 0.57 | 1.76 ± 0.60 | 0.002 | 1.94 ± 0.57 | 1.65 ± 0.35 | < 0.001 |
Neointima | ||||||
Homogeneous | 213 (93%) | 162 (85%) | 213 (93%) | 79 (89%) | ||
Heterogeneous | 16 (7%) | 29 (15%) | 0.007 | 16 (7%) | 10 (11%) | 0.214 |
Cross-section with intraluminal mass | 3 (1.3%) | 2 (1.1%) | 1.000 | 3 (1.3%) | 2 (2.3%) | 0.622 |
Cross-section with malapposition area > 0 | 7 (3.1%) | 6 (3.1%) | 0.960 | 7 (3.1%) | 0 (0.0%) | 0.098 |
Cross-section with uncovered struts | 43 (19%) | 45 (24%) | 0.230 | 43 (19%) | 19 (21%) | 0.603 |
Cross-section with malapposed and uncovered struts | 0 | 1 (0.5%) | 0.455 | 0 | 0 (0.0%) | |
In stent/scaffold obstruction (%) | 9.59 ± 4.81 | 7.01 ± 2.52 | < 0.001 | 9.59 ± 4.81 | 8.12 ± 2.73 | 0.007 |
Stent strut level analysis | Absorb (2062) | Synergy (1880) | Absorb (2062) | Synergy (778) | ||
Uncovered struts (n, %) | 47 (2.3%) | 143 (7.6%) | < 0.001 | 47 (2.3%) | 30 (3.9%) | 0.021 |
Malapposed struts (n, %) | 7 (0.3%) | 23 (1.2%) | 0.001 | 7 (0.3%) | 1 (0.1%) | 0.692 |
Malapposed and uncovered (n, %) | 0 (0.0%) | 4 (0.2%) | 0.052 | 0 (0.0%) | 0 (0.0%) | |
Neointimal thickness per strut (mm2) | 0.06 ± 0.06 | 0.05 ± 0.04 | < 0.001 | 0.06 ± 0.06 | 0.05 ± 0.03 | < 0.001 |