Background
Methods
Patient population
Study protocol
Continuous glucose monitoring and analysis of glucose fluctuations
Pre-intervention IVUS and VH-IVUS analysis
OCT examination
OCT analysis
Three-dimensional assessment of neointimal distribution
Outcome variables and definitions
Statistical analysis
Results
Baseline patient characteristics
Overall (n = 50) | DM (n = 29) | Non-DM (n = 21) | P value (DM vs. non-DM) | |
---|---|---|---|---|
Age (years) | 70.1 ± 10.3 | 71.6 ± 8.8 | 68.0 ± 12.1 | 0.23 |
BMI (kg/m2) | 24.2 ± 3.4 | 24.5 ± 3.0 | 23.8 ± 4.0 | 0.45 |
Male | 43 (86.0) | 24 (82.8) | 19 (90.5) | 0.36 |
DM | 29 (58.0) | 29 (100) | 0 (0.0) | – |
Hypertension | 37 (74.0) | 22 (75.9) | 15 (71.4) | 0.72 |
Dyslipidemia | 44 (88.0) | 27 (93.1) | 17 (81.0) | 0.19 |
Smoking | 36 (72.0) | 21 (72.4) | 15 (71.4) | 0.38 |
Current | 10 (20.0) | 4 (13.8) | 6 (28.6) | |
Former (quit >3 months) | 26 (52.0) | 17 (58.6) | 9 (42.9) | |
Prior myocardial infarction | 12 (24.0) | 6 (20.7) | 6 (28.6) | 0.52 |
Prior PCI | 25 (50.0) | 16 (55.2) | 9 (42.9) | 0.39 |
Systolic blood pressure (mmHg) | 122.1 ± 11.8 | 122.1 ± 11.3 | 122.1 ± 12.7 | 0.99 |
Diastolic blood pressure (mmHg) | 63.3 ± 6.9 | 62.0 ± 6.5 | 65.2 ± 7.2 | 0.10 |
Left ventricular ejection fraction (%) | 59.3 ± 10.2 | 61.7 ± 7.2 | 55.7 ± 13.0 | 0.082 |
Duration of DM (years) | 3.4 ± 6.6 | 7.9 ± 1.5 | – | – |
HbA1c (NGSP) (%) | 6.4 ± 0.9 | 6.8 ± 1.0 | 5.8 ± 0.3 | <0.001 |
1,5-AG (μg/mL) | 15.7 ± 7.7 | 13.2 ± 6.7 | 19.5 ± 7.6 | 0.004 |
Glycoalbumin (%) | 16.5 ± 3.2 | 17.6 ± 3.5 | 14.8 ± 1.8 | 0.001 |
75-g OGTT | ||||
Fasting PG (mg/dL) | 102 ± 21 | 111 ± 23 | 89 ± 8 | <0.001 |
2-h PG (mg/dL) | 202 ± 79 | 249 ± 70 | 139 ± 33 | <0.001 |
Fasting IRI (μU/mL) | 7.4 ± 6.0 | 7.9 ± 7.2 | 6.7 ± 4.0 | 0.49 |
2-h IRI (μU/mL) | 103 ± 106 | 111 ± 118 | 91 ± 86 | 0.53 |
HOMA R | 2.0 ± 2.4 | 2.4 ± 3.1 | 1.5 ± 0.8 | 0.21 |
HOMA β | 80.4 ± 59.7 | 63.6 ± 40.5 | 102.7 ± 73.6 | 0.036 |
Total cholesterol (mg/dL) | 157.0 ± 25.9 | 157.1 ± 23.6 | 156.8 ± 29.4 | 0.96 |
LDL cholesterol (mg/dL) | 88.6 ± 18.1 | 90.2 ± 17.6 | 86.2 ± 18.9 | 0.44 |
HDL cholesterol (mg/dL) | 45.8 ± 12.1 | 42.6 ± 10.0 | 50.1 ± 13.6 | 0.039 |
Triglyceride (mg/dL) | 133.2 ± 53.5 | 152.55 ± 53.5 | 107.1 ± 38.6 | 0.002 |
CRP (mg/dL) | 0.17 ± 0.28 | 0.14 ± 0.21 | 0.20 ± 0.34 | 0.47 |
Creatinine (mg/dL) | 0.98 ± 0.25 | 0.99 ± 0.24 | 0.96 ± 0.26 | 0.63 |
Medications during the study | ||||
Aspirin | 42 (84.0) | 25 (86.2) | 17 (81.0) | 0.45 |
Thienopyridine | 23 (46.0) | 13 (44.8) | 10 (47.6) | 0.85 |
Statin | 38 (76.0) | 24 (82.8) | 14 (66.7) | 0.19 |
EPA | 4 (8.0) | 2 (6.9) | 2 (9.5) | 0.56 |
Ezetimibe | 4 (8.0) | 2 (6.9) | 2 (9.5) | 0.56 |
Fibrate | 1 (2.0) | 0 (0.0) | 1 (4.8) | 0.42 |
ACE-I/ARB | 27 (54.0) | 15 (51.7) | 12 (57.1) | 0.70 |
Beta-blocker | 17 (34.0) | 10 (34.5) | 7 (33.3) | 0.93 |
Insulin | 0 (0.0) | |||
Metformin | 2 (4.0) | 2 (6.9) | 0 (0.0) | 0.33 |
SU | 7 (14.0) | 7 (24.1) | 0 (0.0) | 0.016 |
α-GI | 3 (6.0) | 3 (10.3) | 0 (0.0) | 0.19 |
DPP4-I | 9 (18.0) | 9 (18.0) | 0 (0.0) | 0.004 |
Continuous glucose monitoring variables | ||||
MAGE (mg/dL) | 71 ± 33 | 80 ± 35 | 58 ± 28 | 0.018 |
Mean BG (mg/dL) | 128 ± 21 | 137 ± 24 | 116 ± 9 | <0.001 |
Max BG (mg/dL) | 210 ± 42 | 226 ± 44 | 188 ± 27 | <0.001 |
Min BG (mg/dL) | 72 ± 23 | 75 ± 27 | 70 ± 16 | 0.62 |
Time in hyperglycemia (h) | 23.2 ± 24.3 | 32.9 ± 27.4 | 9.1 ± 5.6 | <0.001 |
Time in hypoglycemia (h) | 1.7 ± 3.0 | 1.9 ± 3.5 | 1.5 ± 2.2 | 0.62 |
Lesion characteristics
Overall (n = 60) | DM (n = 37) | Non-DM (n = 23) | P value (DM vs. non-DM) | |
---|---|---|---|---|
Lesion location | 0.72 | |||
LAD | 26 (43.3) | 15 (40.5) | 11 (47.8) | |
LCx | 15 (25.0) | 9 (24.3) | 6 (26.1) | |
RCA | 19 (31.2) | 13 (35.1) | 6 (26.1) | |
AHA/ACC lesion classification | 0.27 | |||
Type A/B1 | 12 (20.0) | 6 (16.2) | 6 (26.1) | |
Type B2/C | 48 (80.0) | 31 (83.8) | 17 (73.9) | |
Chronic total occlusion | 8 (13.3) | 6 (16.2) | 2 (8.7) | 0.34 |
Bifurcation | 16 (26.7) | 9 (24.3) | 7 (30.4) | 0.60 |
IVUS measurements before stenting | ||||
Plaque volume | ||||
Absolute data (mm3) | 98.1 ± 67.7 | 104.0 ± 77.3 | 89.2 ± 50.7 | 0.48 |
Plaque burden (%) | 58.1 ± 10.5 | 57.4 ± 11.7 | 59.2 ± 8.4 | 0.62 |
Lesion length (mm) | 14.4 ± 9.1 | 14..7 ± 10.3 | 14.0 ± 7.1 | 0.81 |
Fibrous | ||||
Absolute data (mm3) | 35.1 ± 25.8 | 37.6 ± 29.0 | 31.4 ± 20.3 | 0.44 |
Relative data (%) | 60.4 ± 9.2 | 60.6 ± 10.0 | 59.9 ± 8.2 | 0.80 |
Fibro-fatty | ||||
Absolute data (mm3) | 7.3 ± 5.5 | 7.8 ± 6.3 | 6.5 ± 4.0 | 0.41 |
Relative data (%) | 12.7 ± 5.2 | 12.1 ± 3.8 | 13.6 ± 6.8 | 0.37 |
Dense-calcium | ||||
Absolute data (mm3) | 5.2 ± 5.4 | 5.5 ± 6.1 | 4.7 ± 4.2 | 0.61 |
Relative data (%) | 7.7 ± 6.0 | 7.4 ± 5.8 | 8.3 ± 6.5 | 0.64 |
Necrotic-core | ||||
Absolute data (mm3) | 12.9 ± 12.4 | 14.4 ± 14.1 | 10.7 ± 9.4 | 0.34 |
Relative data (%) | 19.1 ± 5.3 | 19.8 ± 4.6 | 18.2 ± 6.1 | 0.33 |
Procedural characteristics | ||||
Stent length (mm) | 27.2 ± 13.7 | 30.2 ± 15.8 | 22.3 ± 7.4 | 0.011 |
Stent size (mm) | 3.0 ± 0.4 | 2.9 ± 0.4 | 3.1 ± 0.4 | 0.14 |
Maximum inflation pressure (atm) | 11.1 ± 1.4 | 11.2 ± 1.3 | 11.0 ± 1.6 | 0.55 |
Overlap stenting | 11 (18.3) | 10 (27.0) | 1 (4.3) | 0.026 |
Post-dilatation | 47 (78.3) | 27 (73.0) | 20 (87.0) | 0.17 |
Rotablation | 6 (10.0) | 5 (13.5) | 1 (4.3) | 0.25 |
OCT measurements
Overall (n = 60) | DM (n = 37) | Non-DM (n = 23) | P value (DM vs. non-DM) | |
---|---|---|---|---|
OCT follow-up duration (days) | 277 ± 69 | 287 ± 77 | 261 ± 51 | 0.16 |
Mean stent area (mm2) | 6.7 ± 1.9 | 6.3 ± 1.8 | 7.2 ± 1.9 | 0.063 |
Mean minimum stent area (mm2) | 5.3 ± 1.8 | 5.0 ± 1.7 | 5.8 ± 1.7 | 0.073 |
Mean SEI | 0.89 ± 0.03 | 0.90 ± 0.03 | 0.88 ± 0.02 | 0.060 |
Average of minimum SEI | 0.79 ± 0.07 | 0.79 ± 0.07 | 0.78 ± 0.06 | 0.52 |
Mean lumen area (mm2) | 6.1 ± 1.9 | 5.7 ± 1.77 | 6.7 ± 1.9 | 0.051 |
Mean number of struts | 271 ± 112 | 292 ± 124 | 237 ± 83 | 0.070 |
Mean number of uncovered struts | 2.2 ± 2.9 | 2.4 ± 3.2 | 1.9 ± 2.2 | 0.47 |
Frequency of uncovered struts (%) | 0.78 | 0.79 | 0.78 | 0.97 |
Mean neointimal thickness (µm) | 82 ± 35 | 86 ± 36 | 75 ± 33 | 0.28 |
Mean neointima area (mm2) | 0.63 ± 0.31 | 0.65 ± 0.29 | 0.61 ± 0.35 | 0.60 |
Average of max neointimal thickness (µm) | 350 ± 180 | 420 ± 180 | 380 ± 150 | 0.44 |
Variability in neointima thickness | 67 ± 26 | 73 ± 29 | 59 ± 18 | 0.060 |
Frequency of stent with in-stent thrombi | 5 (8.3) | 5 (13.5) | 0 (0.0) | 0.080 |
Associations of OCT measurements with diabetic control markers and non-glycemic metabolic variables
Variables | Coefficients | SE | t | p value |
---|---|---|---|---|
For variability of NIT | ||||
MAGE | 0.267 | 0.072 | 3.668 | 0.0006 |
Age | −0.071 | 0.278 | −0.258 | 0.80 |
HbA1c | 0.867 | 4.257 | 0.203 | 0.83 |
1,5 AG | −0.403 | 0.382 | −1.054 | 0.29 |
Mean BG | 0.210 | 0.131 | 1.596 | 0.11 |
Time in hypoglycemia | 1.979 | 0.894 | 2.214 | 0.03 |
DM duration | 0.738 | 0.473 | 1.560 | 0.12 |
HOMA R | −2.247 | 1.183 | −1.899 | 0.06 |
Male | −12.36 | 8.000 | −1.545 | 0.12 |
LDL cholesterol | 0.002 | 0.152 | 0.018 | 0.98 |
HDL cholesterol | 0.243 | 0.251 | 0.967 | 0.33 |
TG | −0.047 | 0.052 | −0.902 | 0.37 |
CRP | −8.176 | 13.66 | −0.598 | 0.55 |
For percentage of uncovered struts | ||||
MAGE | 0.016 | 0.002 | 6.092 | <0.0001 |
Age | 0.020 | 0.011 | 1.740 | 0.11 |
HbA1c | 0.183 | 0.180 | 1.016 | 0.31 |
1,5 AG | −0.028 | 0.016 | −1.760 | 0.084 |
Mean BG | 0.006 | 0.005 | 1.135 | 0.26 |
Time in hypoglycemia | 0.072 | 0.039 | 1.835 | 0.072 |
DM duration | −0.018 | 0.020 | −0.889 | 0.37 |
HOMA R | −0.067 | 0.051 | −1.306 | 0.19 |
Male | 0.710 | 0.334 | 2.122 | 0.039 |
LDL cholesterol | 0.002 | 0.006 | 0.376 | 0.70 |
HDL cholesterol | 0.009 | 0.010 | 0.850 | 0.39 |
TG | −0.001 | 0.002 | −0.810 | 0.42 |
CRP | 0.794 | 0.576 | 1.379 | 0.17 |
Variables | Coefficients | SE | T | P value |
---|---|---|---|---|
Variability in neointimal thickness | ||||
MAGE | 0.239 | 0.093 | 2.564 | 0.014 |
Time in hypoglycemia | 0.159 | 1.060 | 0.150 | 0.88 |
HOMA R | −1.619 | 1.108 | −1.461 | 0.15 |
Frequency of uncovered stent struts | ||||
MAGE | 0.018 | 0.004 | 4.869 | <0.0001 |
1,5 AG | −0.002 | 0.013 | −0.149 | 0.88 |
Time in hypoglycemia | −0.057 | 0.040 | −1.405 | 0.16 |
Association between plaque characteristics and follow-up OCT findings
Clinical outcomes
MAGE | HbA1c | Variability in neointimal thickness | % of uncovered struts | MACE | |
---|---|---|---|---|---|
78-year-old man | 73 | 5.9 | 60 | 0.6 | TLR |
77-year-old man | 120 | 7.8 | 186 | 0 | TLR |
71-year-old man | 99 | 6.7 | 74 | 0 | TLR |
71-year-old man | 99 | 6.7 | 100 | 0.8 | TLR |
80-year-old women | 101 | 6.6 | 79 | 0.8 | TLR |
All MACE cases | 99 ± 15 | 6.7 ± 0.7 | 100 ± 53 | 0.4 ± 0.4 | |
Non-MACE cases | 68 ± 34 | 6.4 ± 0.9 | 65 ± 21 | 0.8 ± 0.9 |