Table 1.
Baseline characteristics and invasive procedures by randomized treatment in the overall NSTE-ACS population, and by initial treatment strategy (within the first 10 days after randomization)
Overall NSTE-ACS |
NSTE-ACS with revascularization |
NSTE-ACS without revascularization |
||||
---|---|---|---|---|---|---|
Ticagrelor (N = 5581) | Clopidogrel (N = 5499) | Ticagrelor (N = 2873) | Clopidogrel (N = 2841) | Ticagrelor (N = 2708) | Clopidogrel (N = 2658) | |
Demographics | ||||||
Age, median (25th–75th percentile), years | 64 (56–72) | 64 (56–72) | 63 (55–71) | 63 (55–71) | 65 (57–73) | 65 (57–73) |
Age ≥ 75 years, n (%) | 955 (17.1) | 1024 (18.6) | 420 (14.6) | 460 (16.2) | 535 (19.8) | 564 (21.2) |
Female gender, n (%) | 1746 (31.3) | 1746 (31.8) | 706 (24.6) | 716 (25.2) | 1040 (38.4) | 1030 (38.8) |
Body weight <60 kg, n (%) | 398 (7.2) | 389 (7.1) | 165 (5.8) | 172 (6.1) | 233 (8.6) | 217 (8.2) |
Body mass index, median (25th–75th percentile), kg/m2 | 27.5 (24.8–30.8) | 27.4 (24.8–30.5) | 27.5 (24.9–30.8) | 27.5 (24.9–30.5) | 27.5 (24.7–30.6) | 27.3 (24.6–30.5) |
GRACE risk score nomogram | 130 (112–150) | 130 (112–149) | 128 (110–145) | 127 (110–145) | 133 (114–154) | 134 (116–153) |
Cardiovascular risk factors, n (%) | ||||||
Current smoking | 1636 (29.4) | 1640 (29.9) | 1000 (34.8) | 960 (33.8) | 636 (23.6) | 680 (25.6) |
Hypertension | 3915 (70.2) | 3835 (69.8) | 1881 (65.5) | 1886 (66.4) | 2034 (75.3) | 1949 (73.4) |
Dyslipidaemia | 2885 (51.8) | 2852 (51.9) | 1515 (52.8) | 1569 (55.2) | 1370 (50.7) | 1283 (48.3) |
Diabetes mellitus | 1608 (28.9) | 1520 (27.7) | 756 (26.3) | 747 (26.3) | 852 (31.6) | 773 (29.1) |
Medical history, n (%) | ||||||
Angina pectoris | 2932 (52.6) | 2890 (52.6) | 1337 (46.5) | 1356 (47.7) | 1595 (59.1) | 1534 (57.8) |
Myocardial infarction | 1400 (25.1) | 1410 (25.7) | 609 (21.2) | 608 (21.4) | 791 (29.3) | 802 (30.2) |
Congestive heart failure | 397 (7.1) | 429 (7.8) | 99 (3.4) | 103 (3.6) | 298 (11.0) | 326 (12.3) |
Percutaneous coronary intervention (PCI) | 944 (16.9) | 918 (16.7) | 537 (18.7) | 517 (18.2) | 407 (15.1) | 401 (15.1) |
Coronary artery bypass graft (CABG) | 434 (7.8) | 474 (8.6) | 214 (7.4) | 218 (7.7) | 220 (8.1) | 256 (9.6) |
Transient ischaemic attack | 185 (3.3) | 189 (3.4) | 82 (2.9) | 74 (2.6) | 103 (3.8) | 115 (4.3) |
Non-hemorrhagic stroke | 246 (4.4) | 243 (4.4) | 81 (2.8) | 98 (3.5) | 165 (6.1) | 145 (5.5) |
Peripheral arterial disease | 400 (7.2) | 413 (7.5) | 174 (6.1) | 204 (7.2) | 226 (8.4) | 209 (7.9) |
Chronic renal disease | 273 (4.9) | 279 (5.1) | 117 (4.1) | 108 (3.8) | 156 (5.8) | 171 (6.4) |
Physical findings, median (25th–75th percentile) | ||||||
Heart rate (bpm) | 72 (64–80) | 72 (64–81) | 71 (62–80) | 72 (63–80) | 72 (64–82) | 72 (64–82) |
Systolic blood pressure (mmHg) | 135 (120–150) | 134 (120–150) | 135 (120–150) | 135 (120–150) | 134 (120–150) | 132 (120–150) |
Diastolic blood pressure (mmHg) | 80 (70–89) | 80 (70–87) | 80 (70–89) | 80 (70–87) | 80 (70–89) | 80 (70–87) |
Risk indicators, n (%) | ||||||
Troponin positive, n (%) | 4356 (80.8) | 4323 (81.3) | 2522 (89.6) | 2486 (89.3) | 1834 (71.3) | 1837 (72.4) |
ST depression (≥1 mm) | 3158 (56.8) | 3201 (58.4) | 1547 (54.0) | 1535 (54.2) | 1611 (59.8) | 1666 (62.8) |
TIMI risk score > 2 | 4838 (89.7) | 4785 (89.8) | 2584 (91.3) | 2566 (91.8) | 2254 (88.0) | 2219 (87.7) |
Type of ACS at discharge, n (%) | ||||||
STEMI | 449 (8.1) | 437 (8.0) | 330 (11.5) | 305 (10.7) | 119 (4.4) | 132 (5.0) |
NSTEMI | 3605 (64.8) | 3525 (64.3) | 2045 (71.2) | 2025 (71.3) | 1560 (58.0) | 1500 (56.7) |
UA/other | 1509 (27.1) | 1524 (27.8) | 497 (17.3) | 510 (18.0) | 1012 (37.6) | 1014 (38.3) |
Antithrombotic treatment during index hospitalization, n (%) | ||||||
Aspirin | 5386 (96.6) | 5316 (96.8) | 2797 (97.4) | 2779 (97.8) | 2589 (95.9) | 2537 (95.8) |
Unfractionated heparin | 2910 (52.1) | 2856 (51.9) | 1845 (64.2) | 1845 (64.9) | 1065 (39.3) | 1011 (38.0) |
Low molecular weight heparin | 3181 (57.0) | 3084 (56.1) | 1568 (54.6) | 1501 (52.8) | 1613 (59.6) | 1583 (59.6) |
Fondaparinux | 194 (3.5) | 191 (3.5) | 87 (3.0) | 76 (2.7) | 107 (4.0) | 115 (4.3) |
Bivalirudin | 140 (2.5) | 133 (2.4) | 135 (4.7) | 122 (4.3) | 5 (0.2) | 11 (0.4) |
GP IIb/IIIa inhibitor | 1170 (21.0) | 1117 (20.3) | 982 (34.2) | 963 (33.9) | 188 (6.9) | 154 (5.8) |
Other drug from randomization to end of study, n (%) | ||||||
Beta-blocker | 4768 (85.4) | 4685 (85.2) | 2536 (88.3) | 2512 (88.4) | 2232 (82.4) | 2173 (81.8) |
ACE-inhibitor and/or ARB | 4693 (84.2) | 4602 (83.8) | 2447 (85.2) | 2433 (85.6) | 2246 (83.2) | 2169 (81.9) |
Statin | 5196 (93.1) | 5109 (92.9) | 2777 (96.7) | 2745 (96.6) | 2419 (89.3) | 2364 (88.9) |
Proton-pump inhibitor | 2776 (49.7) | 2613 (47.5) | 1618 (56.3) | 1536 (54.1) | 1158 (42.8) | 1077 (40.5) |
Calcium channel inhibitor | 1553 (27.8) | 1515 (27.6) | 720 (25.1) | 723 (25.4) | 833 (30.8) | 792 (29.8) |
Diuretic | 2393 (42.9) | 2280 (41.5) | 1073 (37.3) | 1037 (36.5) | 1320 (48.9) | 1243 (46.9) |
Invasive procedures | ||||||
Coronary angiography | ||||||
During first 10 days, n (%) | 4143 (74.5) | 4072 (74.2) | 2873 (100.0) | 2841 (100.0) | 1270 (47.2) | 1231 (46.6) |
After first 10 days, n (%) | 357 (6.4) | 335 (6.1) | 0 (0) | 0 (0) | 357 (13.3) | 335 (12.7) |
PCI | ||||||
During first 10 days, n (%) | 2590 (46.4) | 2550 (46.4) | 2590 (90.1) | 2550 (89.8) | 0 (0) | 0 (0) |
After first 10 days, n (%) | 279 (5.0) | 291 (5.3) | 11 (0.4) | 3 (0.1) | 268 (9.9) | 288 (10.8) |
CABG | ||||||
During first 10 days, n (%) | 296 (5.3) | 305 (5.5) | 296 (10.3) | 305 (10.7) | 0 (0) | 0 (0) |
After first 10 days, n (%) | 382 (6.8) | 375 (6.8) | 55 (1.9) | 55 (1.9) | 327 (12.1) | 320 (12.0) |