Background
Methods
Study population and study protocol
Study devices and anti-thrombotic medications
End points and definitions
Statistical analysis
Results
Patient, lesion, and procedural characteristics and angiographic outcomes
Patient-level characteristics | Sirolimus- and probucol-eluting stent (n = 575) | Zotarolimus-eluting stent (n = 295) | P value |
---|---|---|---|
Age (years) | 69 (61–76) | 70 (62–76) | 0.40 |
Female | 150 (26.1) | 79 (26.8) | 0.83 |
Diabetes mellitus therapy
| |||
Insulin | 197 (34.0) | 109 (37.0) | 0.43 |
Oral antidiabetic drugs | 289 (50.0) | 149 (51.0) | 0.94 |
Hypertension | 547 (95.1) | 281 (95.3) | 0.94 |
Hypercholesterolemia | 389 (68.0) | 188 (64.0) | 0.25 |
Current smoker | 105 (18.0) | 52 (18.0) | 0.82 |
Prior myocardial infarction | 177 (30.8) | 85 (28.8) | 0.55 |
Prior bypass surgery | 59 (10.3) | 34 (11.5) | 0.57 |
Clinical presentation
| 0.46 | ||
Silent ischemia | 36 (6.3) | 15 (5.1) | |
Stable angina | 324 (56.3) | 154 (52.2) | |
Unstable angina | 98 (17.0) | 61 (20.7) | |
Non ST-segment elevation myocardial infarction | 73 (12.7) | 45 (15.3) | |
ST-segment elevation myocardial infarction | 44 (7.7 %) | 20 (6.8 %) | |
Multi-vessel disease | 517 (89.9) | 263 (89.2) | 0.73 |
Ejection fraction (%)a
| 54 (44-60) | 55 (41–61) | 0.56 |
Lesion-level characteristics | Sirolimus- and probucol-eluting stent (n = 849) | Zotarolimus-eluting stent (n = 439) | P value |
---|---|---|---|
Target vessel
| 0.11 | ||
Left anterior descending | 336 (39.6) | 196 (44.6) | |
Left circumflex | 236 (27.8) | 123 (28.0) | |
Right coronary artery | 277 (32.6) | 120 (27.3) | |
Chronic total occlusion | 56 (6.6) | 22 (5.0) | 0.26 |
Bifurcation | 200 (23.6) | 112 (25.5) | 0.44 |
Ostial | 152 (17.9) | 80 (18.2) | 0.89 |
Complex morphology | 626 (74.0) | 336 (77.0) | 0.27 |
Lesion length (mm) | 16.6 ± 9.5 | 17.9 ± 10.4 | 0.07 |
Reference vessel diameter (mm) | 2.75 ± 0.52 | 2.79 ± 0.51 | 0.36 |
Minimal luminal diameter (mm) | 0.91 ± 0.50 | 0.92 ± 0.47 | 0.83 |
Percent diameter stenosis (%) | 67 ± 16 | 67 ± 15 | 0.83 |
Lesion-level characteristics | Sirolimus- and probucol-eluting stent (n = 849) | Zotarolimus-eluting stent (n = 439) | P value |
---|---|---|---|
Balloon diameter (mm) | 3.05 (2.59–3.47) | 3.02 (2.60–3.45) | 0.82 |
Stented length (mm) | 25 (18–34) | 24 (18–33) | 0.23 |
In stent analysis
| |||
Post-procedural minimal luminal diameter (mm) | 2.50 ± 0.50 | 2.57 ± 0.49 | 0.045 |
Post-procedural percent diameter stenosis (%) | 12 ± 7 | 11 ± 7 | 0.03 |
At follow-up minimal luminal diameter (mm)a
| 2.13 ± 0.73 | 2.20 ± 0.72 | 0.18 |
At follow-up percent diameter stenosis (%)a
| 24 ± 22 | 23 ± 21 | 0.68 |
Late lumen loss (mm)a
| 0.36 ± 0.63 | 0.36 ± 0.59 | 0.48 |
In segment analysis
| |||
Post-procedural minimal luminal diameter (mm) | 2.23 ± 0.58 | 2.26 ± 0.55 | 0.33 |
Post-procedural percent diameter stenosis (%) | 22 ± 12 | 22 ± 12 | 0.83 |
At follow-up minimal luminal diameter (mm)a
| 1.90 ± 0.70 | 1.98 ± 0.69 | 0.10 |
At follow-up percent diameter stenosis (%)a
| 33 ± 20 | 32 ± 19 | 0.20 |
Late lumen loss (mm)a
| 0.31 ± 0.61 | 0.26 ± 0.57 | 0.34 |
Binary restenosisa
| 107 (17.0) | 57 (17.2) | 0.95 |
Outcomes at 5 years
Sirolimus- and probucol-eluting stent (n = 575) | Zotarolimus-eluting stent (n = 295) | Hazard ratio [95 % CI] | P value | |
---|---|---|---|---|
Cardiac death, target vessel-related myocardial infarction or target lesion revascularization | 178 (32.9) | 91 (33.4) | 0.98 [0.76–1.26] | 0.88 |
Cardiac death or target vessel-related myocardial infarction | 101 (19.1) | 54 (20.1) | 0.94 [0.67–1.30] | 0.70 |
Cardiac death | 81 (15.6) | 44 (16.7) | 0.92 [0.63–1.32] | 0.64 |
Target vessel-related myocardial infarction | 26 (4.6) | 18 (6.6) | 0.73 [0.40–1.34] | 0.31 |
Target lesion revascularization | 100 (18.6) | 50 (18.8) | 1.00 [0.72–1.41] | 0.98 |
All-cause death | 133 (24.4) | 79 (27.8) | 0.84 [0.63–1.11] | 0.21 |
Any myocardial infarction | 37 (6.5) | 21 (7.6) | 0.90 [0.53–1.54] | 0.70 |
Any revascularization | 234 (43.4) | 124 (46.9) | 0.92 [0.74–1.15] | 0.48 |
Target vessel revascularization | 144 (26.8) | 70 (26.2) | 0.82 [0.78–1.37] | 0.82 |
Definite or probable stent thrombosis | 14 (2.5) | 7 (2.6) | 1.02 [0.41–2.52] | 0.97 |
Definite stent thrombosis | 7 (1.2) | 4 (1.6) | 0.89 [0.26–3.04] | 0.85 |
Probable stent thrombosis | 7 (1.2) | 3 (1.0) | 1.19 [0.31–4.60] | 0.80 |