Background
Methods
Study design
BRS implantation
Quantitative coronary analysis
Endpoints
Statistical methods
All patients (n = 657) | Patients with diabetes (n = 138) | Patients without diabetes (n = 519) | P-value | |
---|---|---|---|---|
Age (years) | 63 ± 12 | 65 ± 11 | 62 ± 12 |
0.015
|
Male | 519/657 (79.0%) | 107/138 (77.5%) | 412/519 (79.4%) | 0.722 |
Hypertension | 478/657 (72.8%) | 117/138 (84.8%) | 361/519 (69.6%) |
< 0.001
|
Smoking | 273/657 (41.6%) | 48/138 (34.8%) | 225/519 (43.3%) | 0.086 |
Family History | 138/657 (21.0%) | 21/138 (15.2%) | 117/519 (22.5%) | 0.078 |
Hyperlipidemia | 268/657 (40.8%) | 76/138 (55.1%) | 192/519 (37.0%) |
< 0.001
|
Prior CABG | 14/657 (2.1%) | 5/138 (3.6%) | 9/519 (1.7%) | 0.186 |
Prior PCI | 181/657 (27.5%) | 48/138 (34.8%) | 133/519 (25.6%) |
0.042
|
Prior stroke/TIA | 27/657 (4.1%) | 11/138 (8.0%) | 16/519 (3.1%) |
0.020
|
eGFR (ml/min) | 83 ± 23 | 76 ± 25 | 84 ± 22 |
< 0.001
|
LVEF (%) | 52 ± 8 | 53 ± 7 | 52 ± 9 | 0.590 |
Silent/stable angina | 219/657 (33.3%) | 56/138 (40.6%) | 163/519 (31.4%) | 0.054 |
Unstable Angina | 78/657 (11.9%) | 20/138 (14.5%) | 58/519 (11.1%) | 0.356 |
NSTEMI | 191/657 (29.1%) | 33/138 (23.9%) | 158/519 (30.4%) | 0.163 |
STEMI | 166/657 (25.3%) | 28/138 (20.3%) | 138/519 (26.6%) | 0.161 |
Lesion characteristics | ||||
LAD treated with BRS | 301/657 (45.8%) | 68/138 (49.3%) | 233/519 (44.9%) | 0.411 |
LCX treated with BRS | 161/657 (24.4%) | 36/138(26.1%) | 125/519(24.1%) | 0.708 |
RCA treated with BRS | 194/657 (29.7%) | 34/138 (24.6%) | 160/519 (30.8%) | 0.190 |
Graft treated with BRS | 1/657 (0.2%) | 0/138 (0%) | 1/519 (0.2%) | 1 |
Ostial lesion | 53/657 (8.1%) | 10/138 (7.2%) | 43/519 (8.3%) | 0.824 |
CTO | 11/657(1.7%) | 2/138 (1.4%) | 15/519 (2.9%) | 0.546 |
Bifurcation | 82/657(12.5%) | 13/138(9.4%) | 69/519(13.3%) | 0.281 |
At least one lesion type B2 or C | 297/657 (45.2%) | 62/138 (44.9%) | 235/519 (45.3%) | 0.982 |
Procedural characteristics | ||||
Number of vessels treated with BVS | 1.2 ± 0.4 | 1.2 ± 0.5 | 1.1 ± 0.4 | 0.095 |
Number of BRS per patient | 1.4 ± 0.8 | 1.5 ± 0.9 | 1.4 ± 0.8 | 0.181 |
vHybrid BRS + DES | 330/657(50.2%) | 56/138(40.6%) | 274/519(52.8%) |
0.014
|
Predilatation | 653/657(99.4%) | 136/138(98.6%) | 517/519(99.6%) | 0.196 |
Diameter predilatation ballon (mm) | 2.80 ± 0.37 | 2.83 ± 0.36 | 2.80 ± 0.37 | 0.367 |
Minimum stent diameter per patient (mm) | 2.97 ± 0.38 | 2.96 ± 0.36 | 2.98 ± 0.38 | 0.572 |
Total implanted length per patient (mm) | 27.5 ± 18.9 | 29.0 ± 19.4 | 27.2 ± 18.8 | 0.324 |
Postdilatation | 306/657(46.6%) | 71/138(51.4%) | 235/519(45.3%) | 0.232 |
Preprocedural RVD, mm | 2.93 ± 0.67 | 2.91 ± 0.77 | 2.94 ± 0.65 | 0.728 |
Preprocedural MLD, mm | 0.61 ± 0.51 | 0.71 ± 0.41 | 0.58 ± 0.54 |
0.026
|
% stenosis per lesion | 78.2 ± 17.9 | 74.6 ± 13.6 | 79.4 ± 18.8 |
0.014
|
Angiographic Outcome | ||||
Postprocedural RVD, mm | 3.0 ± 0.5 | 3.0 ± 0.4 | 3.0 ± 0.5 | 0.760 |
vPostprocedural MLD, mm | 2.5 ± 0.5 | 2.5 ± 0.5 | 2.5 ± 0.5 | 0.135 |
Residual stenosis per lesion (%) | 14.5 ± 10.8 | 16.7 ± 13.2 | 13.7 ± 9.9 |
0.018
|
MLD/nominal BRS diameter | 0.84 ± 0.13 | 0.82 ± 0.16 | 0.85 ± 0.13 | 0.101 |
Lumen Gain, mm | 1.63 ± 0.62 | 1.61 ± 0.61 | 1.68 ± 0.56 | 0.382 |
Optimal implantation technique | 311/657 (47.3%) | 74/138 (53.6%) | 237/519 (45.7%) | 0.117 |
Overlap | 74/657 (11.3%) | 12/138 (8.7%) | 62/519 (11.9%) | 0.357 |
Clopidogrel | 200/657 (30.4%) | 51/138 (37.0%) | 149/519 (28.7%) | 0.077 |
Prasugrel | 324/657 (49.3%) | 67/138 (48.6%) | 257/519 (49.5%) | 0.915 |
Ticagrelor | 132/657 (20.1%) | 19/138 (13.8%) | 113/519 (21.8%) | 0.076 |
Results
Patients and baseline characteristics
QCA and angiographic outcome
Follow-up
Within 30 Days | Between 31 Days and 1 year | After 1 year | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
All | Diab | No Diab | P | HR [95% CI] | All | Diab | No Diab | P | HR [95% CI] | All | Diab | No Diab | p | HR [95% CI] | |
All Death | 12 (1.9%) | 2 (1.5%) | 10 (2.0%) | 0.713 | 0.75 [0.19–3.02] | 7 (1.2%) | 1 (0.8%) | 6 (1.3%) | 0.666 | 0.63 [0.10–3.89] | 24 (5.2%) | 8 (7.7%) | 16 (4.5%) | 0.129 | 1.91 [0.71–5.11] |
CV Death | 7 (1.1%) | 2 (1.5%) | 5 (1.0%) | 0.623 | 1.50 [0.24–9.26] | 5 (0.8%) | 0 | 5 (1.0%) | 0.250 | – |
12 (2.5%)
|
7 (6.9%)
|
5 (1.4%)
|
0.001
|
5.37 [1.33–21.71]
|
Any MI | 12 (1.9%) | 4 (3.0%) | 8 (1.6%) | 0.286 | 1.90 [0.47–7.64] | 16 (2.7%) | 4 (3.3%) | 12 (2.6%) | 0.661 | 1.29 [0.38–4.32] | 25 (5.5%) | 6 (6.4%) | 19 (5.3%) | 0.705 | 1.19 [0.46–3.13] |
Target Vessel MI | 10 (1.6%) | 3 (2.2%) | 7 (1.4%) | 0.477 | 1.62 [0.35–7.46] | 12 (2.0%) | 4 (3.3%) | 8 (1.7%) | 0.275 | 1.93 [0.48–7.81] | 15 (2.8%) | 3 (2.6%) | 12 (2.8%) | 0.928 | 0.94 [0.27–3.27] |
ScR | – | – | – | – | – | 13 (2.2%) | 5 (4.0%) | 8 (1.7%) | 0.116 | 2.38 [0.62–9.09] |
28 (10.3%)
|
13 (17.6%)
|
15 (7.8%)
|
< 0.001
|
3.56 [1.40–9.05]
|
ScT | 14 (2.2%) | 3 (2.2%) | 11 (2.2%) | 0.963 | 1.03 [0.28–3.73] | 5 (0.9%) | 0 | 5 (1.1%) | 0.251 | – | 9 (1.7%) | 1 (1.4%) | 8 (1.8%) | 0.459 | 0.46 [0.09–2.30] |
TLR | – | – | – | – | – | 22 (3.7%) | 6 (4.9%) | 16 (3.4%) | 0.443 | 1.44 [0.51–4.04] |
33 (11.5%)
|
12 (17.0%)
|
21 (9.5%)
|
0.016
|
2.32 [0.98–5.47]
|
Patient level | Lesion level | |||||||
---|---|---|---|---|---|---|---|---|
Unadjusted | Average treatment effect-adjusted | Unadjusted | Average treatment effect -adjusted | |||||
p | HR 95% CI | p | HR 95% CI | p | HR 95% CI | p | HR 95% CI | |
DoCE | 0.026 | 1.74 [1.07–2.83] | 0.0026 | 1.59 [1.18–2.16] | 0.045 | 1.65 [1.01–2.68] | 0.003 | 1.58 [1.17–2.13] |
ScT | 0.6 | 0.75 [0.26–2.18] | 0.43 | 0.79 [0.44–1.42] | 0.52 | 0.7 [0.24–2.05] | 0.2 | 0.68 [0.37–1.23] |
ScR | 0.0067 | 2.52 [1.29–4.91] | 0.00038 | 2.2 [1.42–3.41] | 0.0051 | 2.37 [1.3–4.35] | 0.00077 | 1.97 [1.33–2.92] |
Implantation technique
Diabetes | Implantation Technique | |||
---|---|---|---|---|
No (63) | Yes (74) | p | HR 95% KI | |
all death | 4/63 6%) | 7/74 (9%) | 0.3415 | 0.56 0.17–1.84 |
CV death | 3/63 (5%) | 6/74 (8%) | 0.284 | 0.48 0.13–1.81 |
any MI | 10/63 (16%) | 5/74 (7%) | 0.1207 | 2.28 0.81–6.17 |
TV- MI | 9/63 (14%) | 1/74 (1%) |
0.006
| 10.27 1.64–19.80 |
TLR | 19/63 (30%) | 2/74 (3%) |
0.0001
| 10.79 22.49–13.97 |
TVR | 25/63 (40%) | 7/74 (9%) |
0.0001
| 4.41 1.94–7.86 |
ScR | 17/63 (27%) | 1/74 (1%) |
0.0001
| 18.54 2.61–16.80 |
ScT | 2/63 (3%) | 2/74 (3%) | 0.9722 | 1.03 0.14–7.45 |
DOCE | 22/63 (35%) | 8/74 (11%) |
0.0021
| 3.29 1.51–6.41 |
Diabetes without vs. Diabetes with optimal implantation | Diabetes vs No diabetes, both with optimal implantation | Diabetes vs No Diabetes, both without optimal implantation | No diabetes without vs. no diabetes with optimal implantation | |
---|---|---|---|---|
ScT | 1.083 [0.215–5.458] |
6.641 [1.849–23.854]
| 0.369 [0.101–1.348] |
19.503 [8.451–45.010]
|
ScR |
18.596 [4.719–73.284]
| 0.419 [0.142–1.233] |
5.360 [1.800–15.956]
| 1.452 [0.728–2.895] |