Background
Methods
Patients population
Interventional procedures
Clinical and angiographic follow-up and quantitative coronary angiography
Definitions and outcomes analysis
Statistical analysis
Results
Baseline clinical and angiographic characteristics
EES (N = 405) | R-ZES (N = 274) | P value | |
---|---|---|---|
Age, years | 63.9 ± 11.8 | 64.9 ± 11.9 | 0.264 |
Male | 297 (73.3%) | 197 (71.9%) | 0.680 |
Coexisting condition
| |||
Diabetes mellitus | 157 (38.8%) | 101 (36.9%) | 0.616 |
Hypertension | 283 (69.9%) | 172 (62.8%) | 0.056 |
Dyslipidemia | 140 (34.6%) | 91 (33.2%) | 0.714 |
Cerebrovascular disease | 35 (8.7%) | 18 (6.6%) | 0.325 |
Peripheral artery disease | 9 (2.2%) | 9 (3.3%) | 0.398 |
Chronic renal failure | 15 (3.7%) | 14 (5.1%) | 0.374 |
Cardiovascular risk factors
| |||
Current smoker | 103 (25.4%) | 77 (28.1%) | 0.439 |
Previous PCI | 69 (17.0%) | 40 (14.6%) | 0.396 |
Previous CABG | 5 (1.2%) | 5 (1.8%) | 0.531 |
Previous MI | 33 (8.1%) | 25 (9.1%) | 0.842 |
Clinical indications
| |||
Stable angina | 189 (46.7%) | 124 (45.3%) | 0.717 |
Unstable angina | 99 (24.4%) | 64 (23.4%) | 0.745 |
Acute myocardial infarction | 117 (28.9%) | 86 (31.4%) | 0.485 |
Emergency PCI for acute STEMI | 41 (10.1%) | 34 (12.4%) | 0.351 |
Left ventricular ejection fraction | 57.11 ± 10.40 | 56.25 ± 11.71 | 0.374 |
Severe LV dysfunction (LVEF < 30%) | 6 (1.5%) | 7 (2.6%) | 0.317 |
Multivessel disease | 275 (67.9%) | 207 (75.5%) | 0.031 |
Complex patient†
| 293 (72.3%) | 208 (75.9%) | 0.328 |
EES (N = 500) | R-ZES (N = 366) | P value | |
---|---|---|---|
Before index procedure
| |||
Target vessel location | 0.509 | ||
Left main | 32 (6.4%) | 11 (3.0%) | |
LAD | 252 (50.4%) | 168 (45.9%) | |
LCX | 109 (21.8%) | 95 (26.0%) | |
RCA | 135 (27.0%) | 100 (27.3%) | |
Type B2 or C lesions†
| 315 (63.0%) | 227 (62.0%) | 0.769 |
In-stent restenosis | 39 (7.8%) | 15 (4.1%) | 0.032 |
Chronic total occlusion | 14 (2.8%) | 20 (5.5%) | 0.052 |
Bifurcation‡
| 31 (6.2%) | 31 (8.5%) | 0.201 |
Small vessel§
| 169 (33.8%) | 167 (45.6%) | 0.001 |
Long lesion¶
| 102 (20.4%) | 69 (18.9%) | 0.572 |
Lesion length, mm | 20.63 ± 9.89 | 21.10 ± 10.32 | 0.530 |
Reference diameter, mm | 2.90 ± 0.59 | 2.79 ± 0.58 | 0.012 |
Minimum lumen diameter, mm | 0.75 ± 0.49 | 0.72 ± 0.51 | 0.352 |
Percent stenosis, % | 79.60 ± 15.35 | 78.03 ± 17.05 | 0.162 |
After index procedure
| |||
Number of stents/lesion | 1.23 ± 0.47 | 1.20 ± 0.43 | 0.226 |
Total stent length/lesion, mm | 27.83 ± 13.33 | 28.16 ± 12.55 | 0.717 |
Pressure deployment, atm | 15.02 ± 5.94 | 15.12 ± 4.74 | 0.783 |
Mean stent diameter/lesion, mm | 3.11 ± 0.45 | 2.91 ± 0.40 | < 0.001 |
Minimum lumen diameter, mm | |||
In-stent | 2.61 ± 0.47 | 2.51 ± 0.43 | 0.001 |
In-segment | 2.60 ± 0.48 | 2.49 ± 0.45 | 0.001 |
Percent stenosis, % | |||
In-stent | 12.85 ± 7.00 | 11.71 ± 7.11 | 0.019 |
In-segment | 12.35 ± 7.32 | 11.38 ± 7.58 | 0.063 |
Acute gain, mm | |||
In-stent | 1.88 ± 0.61 | 1.80 ± 0.55 | 0.094 |
In-segment | 1.86 ± 0.63 | 1.79 ± 0.57 | 0.128 |
Angiographic outcomes and at 9 months
EES (Lesion n = 324) | R-ZES (Lesion n = 240) | P value | |
---|---|---|---|
Number of patients
|
264 (65.2%)
|
181 (66.1%)
|
0.869
|
Before index procedure
| |||
Lesion length, mm | 20.33 ± 10.04 | 20.89 ± 8.89 | 0.528 |
Reference diameter, mm | 2.88 ± 0.60 | 2.77 ± 0.50 | 0.038 |
Minimum lumen diameter, mm | 0.73 ± 0.50 | 0.71 ± 0.53 | 0.769 |
Percent stenosis, % | 80.73 ± 14.79 | 77.64 ± 17.24 | 0.024 |
After index procedure
| |||
Total stent length, mm | 27.03 ± 12.91 | 28.61 ± 12.88 | 0.153 |
Number of stents/lesion | 1.20 ± 0.45 | 1.20 ± 0.43 | 0.889 |
Minimum lumen diameter, mm | |||
In-stent | 2.60 ± 0.48 | 2.53 ± 0.43 | 0.061 |
In-segment | 2.59 ± 0.50 | 2.50 ± 0.46 | 0.030 |
Percent stenosis, % | |||
In-stent | 13.03 ± 6.92 | 11.17 ± 6.26 | 0.001 |
In-segment | 12.60 ± 7.20 | 11.27 ± 7.53 | 0.037 |
Acute gain, mm | |||
In-stent | 1.89 ± 0.64 | 1.83 ± 0.56 | 0.284 |
In-segment | 1.87 ± 0.67 | 1.80 ± 0.60 | 0.237 |
Follow-up procedure
| |||
Minimum lumen diameter, mm | |||
In-stent | 2.37 ± 0.66 | 2.23 ± 0.64 | 0.017 |
In-segment | 2.36 ± 0.66 | 2.20 ± 0.66 | 0.006 |
Percent stenosis, % | |||
In-stent | 20.65 ± 17.52 | 20.50 ± 19.23 | 0.925 |
In-segment | 19.41 ± 17.30 | 20.68 ± 19.19 | 0.431 |
Late lumen loss, mm | |||
In-stent | 0.24 ± 0.53 | 0.29 ± 0.58 | 0.267 |
In-segment | 0.23 ± 0.52 | 0.29 ± 0.64 | 0.248 |
Loss index | |||
In-stent | 0.19 ± 0.78 | 0.09 ± 0.57 | 0.129 |
In-segment | 0.15 ± 0.81 | 0.07 ± 0.99 | 0.093 |
Binary restenosis, % | |||
In-stent | 18 (5.8%) | 15 (6.8%) | 0.716 |
In-segment | 17 (5.6%) | 15 (6.9%) | 0.582 |
Clinical outcomes up to 3 years of follow-up
EES (N = 405) | R-ZES (N = 274) | P value | |
---|---|---|---|
All cause death | 4.6% (16) | 3.9% (9) | 0.753 |
Cardiac death | 1.7% (6) | 1.7% (4) | 0.962 |
Any myocardial infarction | 2.1% (7) | 1.9% (4) | 0.858 |
Target vessel | 1.8% (6) | 1.4% (3) | 0.732 |
Non Target vessel | 0.3% (1) | 0.4% (1) | 0.760 |
MI due to ST | 1.0% (3) | 1.4% (3) | 0.564 |
Target lesion revascularization | 5.6% (18) | 6.6% (16) | 0.333 |
Target vessel revascularization | 7.7% (26) | 8.3% (20) | 0.539 |
Any revascularization | 19.2% (54) | 17.4% (37) | 0.603 |
Target lesion failure†
| 7.5% (25) | 7.9% (19) | 0.578 |
Patient-oriented composite outcome‡
| 22.8% (69) | 20.1% (44) | 0.888 |
Definite ST | 1.3% (4) | 0.9% (2) | 0.789 |
Acute (0–1 day) | 0.0% | 0.0% | NA |
Subacute (2–30 days) | 0.5% (2) | 0.0% | 0.249 |
Late (31–360 days) | 0.3% (1) | 0.0% | 0.418 |
Very late (≥ 361 days) | 0.5% (1) | 0.9% (2) | 0.296 |
Probable ST | 0.3% (1) | 0.9% (2) | 0.344 |
Acute (0–1 day) | 0.3% (1) | 0.0% | 0.411 |
Subacute (2–30 days) | 0.0% | 0.4% (1) §
| 0.221 |
Late (31–360 days) | 0.0% | 0.0% | NA |
Very late (≥ 361 days) | 0.0% | 0.5% (1) | 0.215 |
Definite/Probable ST | 1.5% (5) | 1.8% (4) | 0.741 |
Subgroup analysis
Propensity score matched group analysis
EES | R-ZES | Adjusted HR*
| 95% CI | P value | |
---|---|---|---|---|---|
All cause death | 4.9 (11) | 3.7 (8) | 1.833 | 0.678-4.957 | 0.232 |
Cardiac death | 2.2 (5) | 1.9 (4) | 1.667 | 0.398-6.974 | 0.484 |
Any myocardial infarction | 2.7 (5) | 2.0 (4) | 1.000 | 0.202-4.955 | >0.999 |
Target vessel | 2.2 (4) | 1.6 (3) | 1.500 | 0.251-8.977 | 0.657 |
Target lesion revascularization | 5.7 (10) | 7.2 (16) | 0.533 | 0.226-1.258 | 0.151 |
Target vessel revascularization | 7.4 (14) | 9.1 (20) | 0.706 | 0.337-1.478 | 0.356 |
Any revascularization | 22.3 (35) | 18.6 (36) | 0.833 | 0.490-1.417 | 0.501 |
Target lesion failure | 8.4 (16) | 8.6 (19) | 0.875 | 0.427-1.793 | 0.715 |
Patient-oriented outcome | 26.4 (46) | 21.1 (42) | 1.029 | 0.642-1.650 | 0.904 |