Baseline characteristics by prior oral anticoagulation status at randomisation
Characteristic | Prior OAC | No prior OAC | P value† | ||
NOAC (N=1227) | VKA (N=1033) | Any OAC* (N=2262) | (N=2352) | ||
Age, median (25th, 75th), years | 71, 64–77 | 71, 65–77 | 71, 65–77 | 70, 64–77 | 0.040 |
Female sex, no (%) | 336 (27.4) | 276 (26.7) | 613 (27.1) | 724 (30.8) | 0.006 |
Race, no/No (%) | 0.018 | ||||
White | 1120/1208 (92.7) | 960/1031 (93.1) | 2082/2241 (92.9) | 2102/2316 (90.8) | |
Black | 14/1208 (1.2) | 12/1031 (1.2) | 26/2241 (1.2) | 33/2316 (1.4) | |
Asian | 35/1208 (2.9) | 32/1031 (3.1) | 67/2241 (3.0) | 73/2316 (3.2) | |
Other | 39/1208 (3.2) | 27/1031 (2.6) | 66/2241 (2.9) | 108/2316 (4.7) | |
Serum creatinine, median (25th, 75th), mg/dL | 1.0, 0.9–1.2 | 1.0, 0.9–1.2 | 1.0, 0.9–1.2 | 1.0, 0.9–1.2 | 0.020 |
Serum creatinine, no/No (%) | 0.56 | ||||
<1.5 mg/dL | 1114/1210 (92.1%) | 938/1024 (91.6%) | 2054/2236 (91.9%) | 2098/2296 (91.4%) | |
≥1.5 mg/dL | 96/1210 (7.9%) | 86/1024 (8.4%) | 182/2236 (8.1%) | 198/2296 (8.6%) | |
CHA2DS2-VASc score, mean (SD) | 4.0 (1.5) | 4.1 (1.6) | 4.0 (1.5) | 3.8 (1.6) | <0.001 |
HAS-BLED score, mean (SD) | 2.9 (0.9) | 2.9 (1.0) | 2.9 (1.0) | 2.8 (0.9) | <0.001 |
Hypertension leading to medication use, no (%) | 1104 (90.0%) | 923 (89.4%) | 2029 (89.7%) | 2044 (86.9%) | 0.003 |
Heart failure, no (%) | 546 (44.5%) | 510 (49.4%) | 1056 (46.7%) | 917 (39.0%) | <0.001 |
Diabetes mellitus, no (%) | 472 (38.5%) | 399 (38.6%) | 872 (38.5%) | 806 (34.3%) | 0.003 |
Stroke, TIA, or thromboembolism, no/No (%) | 171/1218 (14.0%) | 173/1027 (16.8%) | 344/2247 (15.3%) | 289/2334 (12.4%) | 0.004 |
Concomitant P2Y12 inhibitor, no (%) | <0.001 | ||||
Clopidogrel | 1123 (91.5%) | 985 (95.4%) | 2110 (93.3%) | 2055 (87.4%) | |
Ticagrelor | 66 (5.4%) | 25 (2.4%) | 91 (4.0%) | 189 (8.0%) | |
Prasugrel | 15 (1.2%) | 6 (0.6%) | 21 (0.9%) | 30 (1.3%) | |
None | 23 (1.9%) | 17 (1.6%) | 40 (1.8%) | 78 (3.3%) | |
Qualifying index event, no/No (%) | <0.001 | ||||
ACS and PCI | 418/1223 (34.2%) | 294/1031 (28.5%) | 712/2256 (31.6%) | 1002/2339 (42.8%) | |
Medically managed ACS | 216/1223 (17.7%) | 305/1031 (29.6%) | 521/2256 (23.1%) | 576/2339 (24.6%) | |
Elective PCI | 589/1223 (48.2%) | 432/1031 (41.9%) | 1023/2256 (45.3%) | 761/2339 (32.5%) | |
Days from ACS or PCI to randomisation, mean (SD) | 6.7 (4.3) | 7.0 (4.2) | 6.8 (4.3) | 6.4 (4.1) | 0.001 |
On OAC prior to index event, no/No (%) | 827/1227 (67.4%) | 677/1033 (65.5%) | 1505/2262 (66.5%) | – | – |
For patients reporting more than one type of anticoagulant, the most recent type is used.
*Two patients reported prior oral anticoagulant use but information about the type of anticoagulant was not reported; they were included in the ‘any OAC’ group.
†P value compares ‘any OAC’ versus ‘no prior OAC’ columns.
ACS, acute coronary syndrome; NOAC, non-vitamin K antagonist oral anticoagulant; OAC, oral anticoagulant; PCI, percutaneous coronary intervention; TIA, transient ischaemic attack; VKA, vitamin K antagonist.