Table 1.
Baseline patient characteristics and inclusion criteriaa
| Drug-coated stent (N = 330) | Bare-metal stent (N = 329) | P-value | |
|---|---|---|---|
| Baseline characteristics | |||
| Age (years) | 76.9 ± 10.0 | 76.5 ± 9.9 | 0.17 |
| Female sex | 122 (37.0) | 110 (33.4) | 0.34 |
| Body mass index | 26.7 ± 4.8 | 26.7 ± 4.5 | 0.98 |
| Diabetes, n/total | 111/328 (33.8) | 108/329 (32.8) | 0.78 |
| Hypertension, n/total | 248/330 (75.2) | 249/327 (76.1) | 0.77 |
| Hypercholesterolaemia | 180/322 (55.9) | 156/321 (57.9) | 0.60 |
| STEMI | 57 (17.2) | 48 (14.5) | 0.40 |
| NSTEMI | 273 (82.8) | 281 (85.5) | 0.40 |
| Creatinine kinase (U/L) | 4.14 ± 7.16 | 3.12 ± 6.40 | 0.17 |
| Creatinine kinase MB (U/L) | 28.19 ± 73.06 | 16.38 ± 30.10 | 0.13 |
| High-sensitive troponin (ng/L) | 12.77 ± 18.94 | 13.80 ± 70.18 | 0.92 |
| Multi-vessel disease | 207/327 (64.1) | 220/323 (68.1) | 0.28 |
| Previous myocardial infarction | 63/329 (19.1) | 82/329 (24.9) | 0.07 |
| Previous PCI | 55/330 (16.7) | 67/328 (20.4) | 0.22 |
| Previous CABG | 24/330 (7.3) | 23/328 (7.0) | 0.90 |
| Congestive heart failure | 29/328 (8.8) | 43/329 (13.1) | 0.08 |
| Atrial fibrillation | 84/330 (25.5) | 109/329 (33.1) | 0.03 |
| Previous stroke | 46/326 (14.1) | 26/329 (7.9) | 0.01 |
| Peripheral vascular disease | 47/325 (14.5) | 49/328 (14.9) | 0.86 |
| Chronic obstructive lung disease | 39/330 (11.8) | 45/328 (13.7) | 0.47 |
| Crusade score | 36.4 ± 13.8 | 36.6 ± 14.1 | 0.87 |
| Criteria for high risk of bleeding | |||
| Oral anti-coagulation planned to continue after PCI | 79 (23.9) | 101 (30.7) | 0.05 |
| Age ≥75 years | 232 (70.3) | 229 (69.6) | 0.85 |
| Haemoglobin <11 g/L or transfusion within 4 weeks before randomization | 73 (22.1) | 79 (24.0) | 0.57 |
| Platelet count <100 000/mm3 | 4 (1.2) | 6 (1.8) | 0.57 |
| Hospital admission for bleeding in previous 12 months | 23 (7.0) | 15 (4.6) | 0.18 |
| Stroke in previous 12 months | 6 (1.8) | 5 (1.5) | 0.77 |
| Previous intracerebral bleed | 7 (2.1) | 7 (2.1) | 0.99 |
| Severe chronic liver disease | 4 (1.2) | 4 (1.2) | 0.99 |
| Creatinine clearance <40 mL/min | 62 (18.8) | 80 (24.3) | 0.08 |
| Cancer (non-skin) in the previous 3 years | 35 (10.6) | 37 (11.2) | 0.79 |
| Planned major surgery in next 12 months | 38 (11.5) | 36 (10.9) | 0.82 |
| Glucocorticoids or NSAID planned for >30 days after PCI | 14 (4.2) | 12 (3.6) | 0.70 |
| Expected non-adherence to >30 days of dual antiplatelet therapy | 18 (5.5) | 19 (5.8) | 0.86 |
STEMI, ST-elevation myocardial infarction; NSTEMI, non-ST-segment myocardial infarction; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting.
aEither presented as n (%) or mean ± SD.