Introduction
Methods
Patient population and study design
Clinical follow-up, monitoring, adjudication, and angiographic analysis
Data analysis
Clinical endpoints
Statistical analysis
Results
Baseline, lesion, and procedural characteristics
Patient characteristics | All patients
n = 1811 |
p
| |
---|---|---|---|
BL
n = 465 | Non-BL
n = 1346 | ||
Age (years) | 63.8 ± 11.3 | 64.0 ± 10.7 | 0.74 |
Female | 100 (21.5) | 389 (28.9) | 0.002 |
BMI (kg/m2) | 27.9 ± 4.5* | 28.0 ± 4.8†
| 0.71 |
Diabetes mellitus | 83 (17.8) | 241 (17.9) | 0.98 |
Previous MI | 112 (24.1) | 285 (21.2) | 0.19 |
Previous PCI | 85 (18.3) | 264 (19.6) | 0.53 |
Previous CABG | 42 (9.0) | 131 (9.7) | 0.66 |
Clinical syndrome at index PCI procedure | |||
Stable angina pectoris | 218 (46.9) | 531 (39.5) | 0.005 |
Unstable angina pectoris | 57 (12.3) | 188 (14.0) | |
Non-ST-elevation myocardial infarction | 118 (25.4) | 329 (24.4) | |
ST-elevation myocardial infarction | 72 (15.5) | 298 (22.1) |
Lesion/procedural characteristics | All patients (n = 1811) |
p
| |
---|---|---|---|
BL
n = 465 | Non-BL
n = 1346 | ||
Multivessel treatment | 123 (26.5) | 173 (12.9) | <0.001 |
Treated coronary vessels | |||
Right coronary artery | 91 (19.6) | 578 (42.9) | <0.001 |
Left anterior descending artery | 336 (72.3) | 518 (38.5) | <0.001 |
Circumflex artery | 148 (31.8) | 375 (27.9) | 0.10 |
De novo lesion | 423 (91.0) | 1204 (89.5) | 0.35 |
Severe calcification | 106 (22.8) | 301 (22.4) | 0.85 |
At least one chronic total occlusion | 19 (4.1) | 57 (4.2) | 0.89 |
At least one in-stent restenosis | 17 (3.7) | 38 (2.8) | 0.37 |
At least one small vessel | 298 (64.1) | 770 (57.2) | 0.01 |
At least one lesion length >27 mm | 95 (20.4) | 223 (16.6) | 0.06 |
Medina classification of bifurcation lesions | |||
0.0.1 | 37 (8.0) | ||
0.1.0 | 67 (14.4) | ||
0.1.1 | 21 (4.5) | ||
1.0.0 | 55 (11.8) | ||
1.0.1 | 39 (8.4) | ||
1.1.0 | 148 (31.8) | ||
1.1.1 | 98 (21.1) | ||
Total stent length | 36.0 (22.0–56.0) | 28.0 (18.0–48.0) | <0.001 |
Number of stents per patient | 2.1 (1.3) | 1.7 (1.0) | <0.001 |
Longest lesion length (mm) | 19.4 (12.0) | 18.3 (12.1) | 0.09 |
Degree of stenosis (pre-PCI)* | 70.2 (16.9) | 71.1 (18.2) | 0.36 |
Residual in-stent stenosis (post-PCI)* | 17.9 (8.7) | 17.3 (8.1) | 0.22 |
Postdilation | 397 (85.4) | 1006 (74.7) | <0.001 |
Stenting approach | |||
1-stent | 387 (83.2) | ||
2-stent | 78 (16.8) | ||
T-stenting | 57 (73.1) | ||
(Mini)crush | 14 (17.9) | ||
Culotte | 2 (2.6) | ||
Other | 5 (6.4) | ||
Final kissing-balloon inflation | 139 (29.9) |
Clinical event rates and multivariate analysis at 2-year follow-up
All patients
n = 1810 |
p
| ||
---|---|---|---|
BL
n = 465 | Non-BL
n = 1345 | ||
Cardiac death | 8 (1.7) | 31 (2.3) | 0.45 |
Target vessel myocardial infarction | 16 (3.4) | 22 (1.6) | 0.02 |
Periprocedural myocardial infarction* | 15 (3.2) | 15 (1.1) | 0.002 |
Target vessel revascularization†
| 21 (4.5) | 65 (4.8) | 0.78 |
Target lesion revascularization†
| 16 (3.4) | 50 (3.7) | 0.78 |
Definite stent thrombosis | 2 (0.4) | 13 (1.0) | 0.38 |
Definite or probable stent thrombosis | 4 (0.9) | 16 (1.2) | 0.56 |
Target vessel failure | 43 (9.2) | 106 (7.9) | 0.36 |
Target lesion failure | 38 (8.2) | 93 (6.9) | 0.37 |
Major adverse cardiac events | 43 (9.2) | 112 (8.3) | 0.54 |
Patient-oriented composite endpoint | 60 (12.9) | 168 (12.5) | 0.82 |
Clinical outcome among patients with bifurcated lesions
Patient characteristics | Stent used
n = 465 | Maximum side-branch (SB) diameter (mm) n = 465 | Kissing-balloon inflation
n = 465 | Stenting approach
n = 465 | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Resolute integrity
n = 244 | Promus element
n = 221 |
p
| SB < 2.0
n = 123 | SB ≥ 2.0
n = 342 |
p
| KB
n = 139 | No KB
n = 326 |
p
| 1-Stent
n = 387 | 2-Stent
n = 78 |
p
| |
Cardiac death | 4 (1.6) | 4 (1.8) | 1.00 | 0 | 8 (2.3) | 0.12 | 1 (0.7) | 7 (2.1) | 0.45 | 7 (1.8) | 1 (1.3) | 1.00 |
Target vessel myocardial infarction | 9 (3.7) | 7 (3.2) | 0.76 | 3 (2.4) | 13 (3.8) | 0.58 | 6 (4.3) | 10 (3.1) | 0.50 | 9 (2.3) | 7 (9.0) | 0.003 |
Periprocedural myocardial infarction* | 9 (3.7) | 6 (2.7) | 0.55 | 3 (2.4) | 12 (3.5) | 0.57 | 6 (4.3) | 9 (2.8) | 0.39 | 8 (2.1) | 7 (9.0) | 0.002 |
Target vessel revascularization†
| 12 (4.9) | 9 (4.1) | 0.66 | 7 (5.7) | 14 (4.1) | 0.46 | 4 (2.9) | 17 (5.2) | 0.27 | 5 (3.6) | 17 (5.2) | 0.45 |
Target lesion revascularization†
| 10 (4.1) | 6 (2.7) | 0.41 | 7 (5.7) | 9 (2.6) | 0.11 | 4 (2.9) | 12 (3.7) | 0.88 | 15 (3.9) | 2 (0.5) | 0.75 |
Definite stent thrombosis | 1 (0.4) | 1 (0.5) | 1.00 | 0 | 2 (0.6) | 1.00 | 0 | 2 (0.6) | 1.00 | 2 (0.5) | 0 | 1.00 |
Definite or probable stent thrombosis | 2 (0.8) | 2 (0.9) | 1.00 | 0 | 4 (1.2) | 0.58 | 1 (0.7) | 3 (0.9) | 1.00 | 3 (0.8) | 1 (1.3) | 0.52 |
Target vessel failure | 24 (9.8) | 19 (8.6) | 0.65 | 10 (8.1) | 33 (9.6) | 0.62 | 11 (7.9) | 32 (9.8) | 0.52 | 32 (8.3) | 11 (14.1) | 0.11 |
Target lesion failure | 22 (9.0) | 16 (7.2) | 0.49 | 10 (8.1) | 28 (8.2) | 0.98 | 11 (7.9) | 27 (8.3) | 0.89 | 28 (7.2) | 10 (12.8) | 0.10 |
Major adverse cardiac events | 24 (9.8) | 19 (8.6) | 0.65 | 10 (8.1) | 33 (9.6) | 0.62 | 12 (8.6) | 31 (9.5) | 0.77 | 32 (8.3) | 11 (14.1) | 0.11 |
Patient-oriented composite endpoint | 33 (13.5) | 27 (12.2) | 0.68 | 12 (9.8) | 48 (14.0) | 0.23 | 13 (9.4) | 47 (14.4) | 0.14 | 47 (12.1) | 13 (16.7) | 0.28 |