Background
Methods
Study population
Procedural details
Follow-up and definitions
Statistical analysis
Results
Baseline, angiographic and procedural characteristics of the patients
Characteristics | DM |
P
| No-DM |
P
| ||
---|---|---|---|---|---|---|
G2‑DES N = 1862 | BP‑DES N = 421 | G2‑DES N = 4232 | BP‑DES N = 1151 | |||
Age (years) | 59.0 ± 9.7 | 59.7 ± 9.7 | 0.814 | 57.5 ± 10.6 | 58.5 ± 10.4 | 0.241 |
Sex (male) | 1411 (75.8) | 314 (74.6) | 0.607 | 3307 (78.1) | 872 (75.8) | 0.085 |
BMI (kg/m2) | 26.3 ± 3.1 | 26.2 ± 3.1 | 0.595 | 25.8 ± 3.2 | 25.8 ± 3.1 | 0.754 |
LVEF (%) | 62.7 ± 7.5 | 61.8 ± 7.9 | 0.207 | 63.1 ± 7.2 | 61.8 ± 7.9 | 0.262 |
Hypertension (n, %) | 1284 (69.0) | 314 (74.6) | 0.023 | 2545 (60.1) | 726 (63.1) | 0.070 |
Hyperlipidemia (n, %) | 1383 (74.3) | 306 (72.7) | 0.502 | 2754 (65.1) | 717 (62.3) | 0.080 |
Current smoker (n, %) | 1014 (54.5) | 240 (57.0) | 0.342 | 2414 (57.0) | 685 (59.5) | 0.132 |
Family history (n, %) | 486 (26.1) | 102 (24.2) | 0.427 | 1047 (24.7) | 264 (22.9) | 0.206 |
Stroke history (n, %) | 231 (12.4) | 60 (14.3) | 0.305 | 369 (8.7) | 118 (10.3) | 0.108 |
PAD (n, %) | 62 (3.3) | 19 (4.5) | 0.236 | 99 (2.3) | 18 (1.6) | 0.110 |
COPD (n, %) | 43 (2.3) | 10 (2.4) | 0.935 | 98 (2.3) | 26 (2.3) | 0.158 |
OMI (n, %) | 348 (18.7) | 101 (24.0) | 0.013 | 749 (17.7) | 211 (18.3) | 0.619 |
Previous PCI (n, %) | 480 (25.8) | 133 (31.6) | 0.015 | 976 (23.1) | 247 (21.5) | 0.250 |
Previous CABG (n, %) | 82 (4.4) | 21 (5.0) | 0.602 | 163 (3.9) | 25 (2.2) | 0.006 |
Serum creatinine (ml/min) | 74.9 ± 16.7 | 76.9 ± 17.8 | 0.233 | 75.4 ± 15.3 | 76.2 ± 15.5 | 0.425 |
HbA1c (%) | 7.8 ± 1.4 | 7.9 ± 1.4 | 0.772 | 6.1 ± 0.6 | 6.1 ± 0.6 | 0.744 |
Clinical presentation (n, %) | ||||||
Stable angia | 796 (42.7) | 175 (41.6) | 0.658 | 1631 (38.5) | 432 (37.5) | 0.533 |
NSTE-ACS | 857 (46.0) | 189 (44.9) | 0.674 | 2026 (47.9) | 534 (46.4) | 0.373 |
STEMI | 209 (11.2) | 57 (13.5) | 0.181 | 574 (13.6) | 185 (16.1) | 0.030 |
Medication (cases, %) | ||||||
Aspirin | 1841 (98.9) | 419 (99.5) | 0.289 | 4173 (98.6) | 1140 (99.0) | 0.244 |
Clopidogrel | 1840 (98.8) | 416 (98.8) | > 0.999 | 4159 (98.3) | 1138 (98.9) | 0.153 |
DAPT | 1821 (97.8) | 415 (98.6) | 0.311 | 4104 (97.0) | 1131 (98.3) | 0.018 |
GP IIIb/IIa inhibitors | 206 (11.1) | 62 (14.7) | 0.035 | 500 (11.8) | 217 (18.9) | < 0.001 |
Statin | 1774 (95.3) | 406 (96.4) | 0.299 | 4071 (96.2) | 1104 (95.9) | 0.663 |
β‑blocker | 1705 (91.6) | 403 (95.7) | 0.004 | 3782 (89.4) | 1021 (88.7) | 0.521 |
Calcium antagonist | 956 (51.3) | 221 (52.5) | 0.669 | 2002 (47.3) | 518 (45.0) | 0.165 |
Nitrate | 1807 (97.0) | 414 (98.3) | 0.141 | 4130 (97.6) | 1127 (97.9) | 0.518 |
PPI | 341 (18.3) | 79 (18.8) | 0.829 | 836 (19.8) | 266 (23.1) | 0.012 |
Therapeutic status for DM (n, %) | ||||||
Diet and exercise | 342 (18.4) | 76 (18.1) | 0.880 | – | – | – |
Antidiabetic agents | 836 (44.9) | 209 (49.6) | 0.078 | – | – | – |
Insulin | 494 (26.5) | 104 (24.7) | 0.441 | – | – | – |
Insulin and antidiabetic agents | 190 (10.2) | 32 (7.6) | 0.104 | – | – | – |
Characteristics | DM |
P
| No-DM |
P
| ||
---|---|---|---|---|---|---|
G2‑DES N = 1862 | BP‑DES N = 421 | G2‑DES N = 4232 | BP‑DES N = 1151 | |||
Lesions involving LM | 46 (2.5) | 9 (2.1) | 0.688 | 81 (1.9) | 15 (1.3) | 0.165 |
Lesions involving LAD | 1703 (91.5) | 377 (89.5) | 0.213 | 3929 (92.8) | 1050 (91.2) | 0.065 |
Lesions involving LCX | 308 (16.5) | 56 (13.3) | 0.101 | 565 (13.4) | 163 (14.2) | 0.476 |
Lesions involving RCA | 373 (20.0) | 94 (22.3) | 0.292 | 713 (16.8) | 183 (15.9) | 0.444 |
Number of lesions treated | 1.4 ± 0.6 | 1.4 ± 0.6 | 0.664 | 1.3 ± 0.59 | 1.34 ± 0.60 | 0.013 |
Number of stents | 1.8 ± 1.0 | 1.7 ± 0.9 | 0.177 | 1.75 ± 0.89 | 1.67 ± 0.88 | 0.391 |
Number of target vessel | ||||||
Single vessel | 386 (20.7) | 70 (16.6) | 0.057 | 1320 (31.2) | 340 (29.5) | 0.282 |
Double vessel | 576 (30.9) | 143 (34.0) | 0.578 | 1316 (31.1) | 379 (32.9) | 0.236 |
Triple vessel | 779 (41.8) | 185 (43.9) | 0.429 | 1349 (31.9) | 378 (32.8) | 0.534 |
SYNTEX score | 11.7 ± 8.0 | 11.9 ± 8.2 | 0.684 | 10.9 ± 7.7 | 11.0 ± 7.8 | 0.329 |
Normal origin of coronary artery | 1774 (95.3) | 403 (95.7) | 0.692 | 4051 (95.7) | 1102 (95.7) | 0.977 |
Right distribution of coronary artery | 1633 (87.7) | 382 (90.7) | 0.081 | 3747 (88.5) | 1019 (88.5) | 0.994 |
Transradial approach | 1664 (89.4) | 375 (89.1) | 0.861 | 3813 (90.1) | 1011 (87.8) | 0.026 |
Pulling out sheath directly | 1408 (75.6) | 328 (77.9) | 0.320 | 3277 (77.4) | 904 (78.5) | 0.424 |
IVUS application | 97 (5.2) | 16 (3.8) | 0.229 | 218 (5.2) | 58 (5.0) | 0.878 |
IABP application | 25 (1.3) | 5 (1.2) | 0.801 | 40 (0.9) | 12 (1.0) | 0.765 |
TIMI flow before PCI | ||||||
0 | 321 (17.2) | 71 (16.9) | 0.995 | 678 (16.0) | 235 (20.4) | < 0.001 |
1 | 61 (3.3) | 20 (4.8) | 0.626 | 123 (2.9) | 35 (3.0) | 0.811 |
2 | 221 (11.9) | 36 (8.6) | 0.290 | 483 (11.4) | 125 (10.9) | 0.599 |
3 | 1259 (67.6) | 294 (69.8) | 0.247 | 2948 (69.7) | 756 (65.7) | 0.010 |
TIMI flow after PCI | ||||||
0 | 21 (1.1) | 6 (1.4) | 0.593 | 41 (1.0) | 12 (1.0) | 0.822 |
1 | 3 (0.2) | 0 (0) | > 0.999 | 9 (0.2) | 3 (0.3) | 0.728 |
2 | 10 (0.5) | 4 (1.0) | 0.226 | 30 (0.7) | 11 (1.0) | 0.393 |
3 | 1828 (98.2) | 411 (97.6) | 0.754 | 4152 (98.1) | 1125 (97.7) | 0.425 |
B2 or C lesions | 1430 (76.8) | 330 (78.4) | 0.484 | 3101 (73.3) | 885 (76.9) | 0.013 |
severe calcification | 72 (3.9) | 13 (3.1) | 0.446 | 115 (2.7) | 29 (2.5) | 0.712 |
CTO lesions | 143 (7.7) | 30 (7.1) | 0.698 | 267 (6.3) | 107 (9.3) | < 0.001 |
Ostial lesions | 316 (17.0) | 66 (15.7) | 0.521 | 697 (16.5) | 178 (15.5) | 0.413 |
Bifurcation lesions | 346 (18.6) | 77 (18.3) | 0.889 | 825 (19.5) | 239 (20.8) | 0.337 |
Thrombosis | 67 (3.6) | 15 (3.6) | 0.972 | 173 (4.1) | 50 (4.3) | 0.699 |
Two-year clinical outcomes of G2-DESs versus BP-DESs
Clinical outcomes (n, %) | DM | No-DM | ||||
---|---|---|---|---|---|---|
G2‑DES N = 1862 | BP‑DES N = 421 |
p
| G2‑DES N = 4232 | BP‑DES N = 1151 |
P
| |
MACE | 219 (11.8) | 60 (14.3) | 0.159 | 403 (9.5) | 129 (11.2) | 0.089 |
All-cause death | 27 (1.5) | 6 (1.4) | 0.969 | 40 (0.9) | 16 (1.4) | 0.187 |
Cardiac death | 16 (0.9) | 2 (0.5) | 0.554 | 25 (0.6) | 6 (0.5) | 0.782 |
Non-fatal MI | 37 (2.0) | 15 (3.6) | 0.050 | 75 (1.8) | 17 (1.5) | 0.493 |
ST | 20 (1.1) | 5 (1.2) | 0.797 | 32 (0.8) | 6 (0.5) | 0.399 |
Revascularization | 145 (7.8) | 39 (9.3) | 0.315 | 279 (6.6) | 89 (7.7) | 0.174 |
TVR | 81 (4.4) | 24 (5.7) | 0.232 | 136 (3.2) | 59 (5.1) | 0.002 |
TLR | 66 (3.5) | 22 (5.2) | 0.106 | 92 (2.2) | 52 (4.5) | < 0.001 |
Stroke | 26 (1.4) | 4 (1.0) | 0.468 | 51 (1.2) | 15 (1.3) | 0.789 |
Bleeding | 124 (6.7) | 21 (5.0) | 0.204 | 310 (7.3) | 79 (6.9) | 0.592 |
BARC 2_5 | 50 (2.7) | 8 (1.9) | 0.355 | 123 (2.9) | 31 (2.7) | 0.701 |
BARC 3_5 | 8 (0.4) | 1 (0.2) | > 0.999 | 24 (0.6) | 4 (0.3) | 0.358 |
Clinical outcomes (n, %) | Univariate multivariate | |||
---|---|---|---|---|
HR (95% CI) |
P
| HR (95% CI) |
P
| |
MACE | 1.245 (0.935–1.656) | 0.133 | 1.252 (0.939–1.669) | 0.126 |
All-cause death | 0.986 (0.407–2.389) | 0.976 | 0.953 (0.387–2.351) | 0.917 |
Cardiac death | 0.555 (0.128–2.412) | 0.432 | 0.410 (0.089–1.879) | 0.251 |
Non-fatal MI | 1.808 (0.992–3.295) | 0.053 | 1.689 (0.913–3.122) | 0.095 |
Stent thrombosis | 1.116 (0.419–2.974) | 0.826 | 1.002 (0.370–2.714) | 0.997 |
Revascularization | 1.205 (0.846–1.717) | 0.300 | 1.215 (0.852–1.733) | 0.283 |
TVR | 1.329 (0.843–2.096) | 0.221 | 1.325 (0.835–2.101) | 0.232 |
TLR | 1.495 (0.923–2.422) | 0.103 | 1.453 (0.891–2.371) | 0.134 |
Stroke | 0.681 (0.237–1.950) | 0.474 | 0.731 (0.253–2.111) | 0.563 |
Bleeding | 0.748 (0.471–1.188) | 0.219 | 0.727 (0.447–1.182) | 0.198 |
BRAC 2_5 | 0.710 (0.337–1.497) | 0.368 | 0.705 (0.333–1.491) | 0.360 |
BRAC 3_5 | 0.554 (0.069–4.432) | 0.578 | 0.563 (0.070–4.535) | 0.590 |
Clinical outcomes (n, %) | Univariate multivariate | |||
---|---|---|---|---|
HR (95% CI) |
P
| HR (95% CI) |
P
| |
MACE | 1.190 (0.976–1.451) | 0.085 | 1.145 (0.937–1.401) | 0.186 |
All-cause death | 1.477 (0.827–2.637) | 0.188 | 1.268 (0.686–2.344) | 0.449 |
Cardiac death | 0.886 (0.363–2.159) | 0.790 | 0.772 (0.293–2.039) | 0.602 |
Non-fatal MI | 0.834 (0.493–1.413) | 0.50 | 0.758 (0.441–1.304) | 0.317 |
Stent thrombosis | 0.692 (0.289–1.654) | 0.407 | 0.573 (0.222–1.480) | 0.250 |
Revascularization | 1.188 (0.936–1.508) | 0.157 | 1.184 (0.931–1.505) | 0.168 |
TVR | 1.619 (1.193–2.198) | 0.002 | 1.539 (1.128–2.099) | 0.007 |
TLR | 2.109 (1.501–2.963) | < 0.001 | 1.963 (1.390–2.772) | < 0.001 |
Stroke | 1.087 (0.611–1.932) | 0.778 | 0.976 (0.538–1.771) | 0.936 |
Bleeding | 1.022 (0.798–1.310) | 0.861 | 1.055 (0.807–1.379) | 0.696 |
BRAC 2_5 | 0.927 (0.625–1.374) | 0.705 | 0.929 (0.625–1.381) | 0.714 |
BRAC 3_5 | 0.613 (0.213–1.766) | 0.364 | 0.630 (0.216–1.839) | 0.397 |