Table 1.
Characteristic | All patients (n=399 344) | Any bleeding | Standardized difference | Major bleeding | Standardized difference | ICH | Standardized difference | GB | Standardized difference | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
No | Yes | No | Yes | No | Yes | No | Yes | ||||||
(n=273 949) | (n=125 395) | (n=356 087) | (n=43 257) | (n=391 800) | (n=7544) | (n=379 319) | (n=20 025) | ||||||
Age, y | 77.9±10.2 | 77.8±10.3 | 78.0±9.9 | 2.0 | 77.9±10.3 | 77.4±9.5 | −4.9 | 77.8±10.2 | 78.9±9.0 | 11.1 | 77.9±10.2 | 77.7±9.3 | −2.2 |
Sex, men | 252 300 (63.2) | 165 965 (60.6) | 86 335 (68.9) | 17.4 | 221 927 (62.3) | 30 373 (70.2) | 16.7 | 247 350 (63.1) | 4950 (65.6) | 5.2 | 238 543 (62.9) | 13 757 (68.7) | 12.3 |
CHA2DS2VASc score | 3.4±1.5 | 3.4±1.5 | 3.6±1.5 | 14.9 | 3.4±1.5 | 3.5±1.5 | 3.1 | 3.4±1.5 | 3.6±1.5 | 11.1 | 3.4±1.5 | 3.5±1.5 | 2.4 |
Hypertension | 255 733 (64.0) | 168 692 (61.6) | 87 041 (69.4) | 16.5 | 226 397 (63.6) | 29 336 (67.8) | 8.9 | 250 679 (64.0) | 5054 (67.0) | 6.3 | 242 285 (63.9) | 13 448 (67.2) | 6.9 |
Diabetes | 89 768 (22.5) | 58 058 (21.2) | 31 710 (25.3) | 9.7 | 78 661 (22.1) | 11 107 (25.7) | 8.4 | 87 906 (22.4) | 1862 (24.7) | 5.3 | 84 763 (22.3) | 5005 (25.0) | 6.2 |
Heart failure | 114 243 (28.6) | 89 893 (32.8) | 49 397 (39.4) | 13.7 | 123 523 (34.7) | 15 767 (36.4) | 3.7 | 136 749 (34.9) | 2541 (33.7) | −2.6 | 132 067 (34.8) | 7223 (36.1) | 2.6 |
Dilated cardiomyopathy | 23 910 (6.0) | 15 415 (5.6) | 8495 (6.8) | 4.8 | 21 095 (5.9) | 2815 (6.5) | 2.4 | 23 455 (6.0) | 455 (6.0) | 0.2 | 22 616 (6.0) | 1294 (6.5) | 2.1 |
Coronary artery disease | 98 260 (24.6) | 60 498 (22.1) | 37 762 (30.1) | 18.4 | 85 874 (24.1) | 12 386 (28.6) | 10.3 | 96 352 (24.6) | 1908 (25.3) | 1.6 | 92 744 (24.5) | 5516 (27.5) | 7.1 |
Previous myocardial infarction | 17 643 (4.4) | 10 556 (3.9) | 7087 (5.7) | 8.5 | 15 613 (4.4) | 2030 (4.7) | 1.5 | 17 361 (4.4) | 282 (3.7) | −3.5 | 16 793 (4.4) | 850 (4.2) | −0.9 |
Previous PCI | 16 692 (4.2) | 9716 (3.5) | 6976 (5.6) | 9.7 | 14 619 (4.1) | 2073 (4.8) | 3.3 | 16 392 (4.2) | 300 (4.0) | −1.0 | 15 819 (4.2) | 873 (4.4) | 0.9 |
Previous CABG | 1965 (0.5) | 7456 (2.7) | 6139 (4.9) | 11.4 | 11 553 (3.2) | 2042 (4.7) | 7.6 | 13 308 (3.4) | 287 (3.8) | 2.2 | 12 723 (3.4) | 872 (4.4) | 5.2 |
Vascular disease | 77 224 (19.3) | 46 334 (16.9) | 30 890 (24.6) | 19.1 | 67 478 (18.9) | 9746 (22.5) | 8.8 | 75 774 (19.3) | 1450 (19.2) | −0.3 | 72 987 (19.2) | 4237 (21.2) | 4.8 |
Dyslipidemia | 95 820 (24.0) | 60 946 (22.2) | 34 874 (27.8) | 4.5 | 84 273 (23.7) | 11 547 (26.7) | 7.0 | 93 950 (24.0) | 1870 (24.8) | 1.9 | 90 626 (23.9) | 5194 (25.9) | 4.7 |
Ischemic stroke | 22 593 (5.7) | 14 597 (5.3) | 7996 (6.4) | 4.5 | 20 382 (5.7) | 2211 (5.1) | −2.7 | 22 001 (5.6) | 592 (7.8) | 8.9 | 21 634 (5.7) | 959 (4.8) | −4.1 |
Previous ICH | 7948 (2.0) | 0 (0.0) | 7948 (6.3) | 36.8 | 6620 (1.9) | 1328 (3.1) | 7.8 | 7948 (2.0) | 0 (0.0) | −20.3 | 7686 (2.0) | 262 (1.3) | −5.6 |
Lung disease | 87 569 (21.9) | 56 481 (20.6) | 31 088 (24.8) | 10.0 | 78 476 (22.0) | 9093 (21.0) | −2.5 | 86 266 (22.0) | 1303 (17.3) | −12.0 | 83 380 (22.0) | 4189 (20.9) | −2.6 |
COPD | 55 891 (14.0) | 35 707 (13.0) | 20 184 (16.1) | 8.7 | 49 775 (14.0) | 6116 (14.1) | 0.5 | 55 102 (14.1) | 789 (10.5) | −11.0 | 53 061 (14.0) | 2830 (14.1) | 0.4 |
Liver disease | 23 265 (5.8) | 13 435 (4.9) | 9830 (7.8) | 12.0 | 20 478 (5.8) | 2787 (6.4) | 2.9 | 22 893 (5.8) | 372 (4.9) | −4.0 | 21 966 (5.8) | 1299 (6.5) | 2.9 |
Thyroid diseases | 39 955 (10.0) | 27 088 (9.9) | 12 867 (10.3) | 1.2 | 35 844 (10.1) | 4111 (9.5) | −1.9 | 39 217 (10.0) | 738 (9.8) | −0.8 | 38 028 (10.0) | 1927 (9.6) | −1.4 |
Inflammatory disease | 30 925 (7.7) | 18 506 (6.8) | 12 419 (9.9) | 11.4 | 27 204 (7.6) | 3721 (8.6) | 3.5 | 30 433 (7.8) | 492 (6.5) | −4.8 | 29 318 (7.7) | 1607 (8.0) | 1.1 |
Cognitive impairment | 33 205 (8.3) | 22 416 (8.2) | 10 789 (8.6) | 1.5 | 30 697 (8.6) | 2508 (5.8) | −10.9 | 32 580 (8.3) | 625 (8.3) | −0.1 | 32 063 (8.5) | 1142 (5.7) | −10.7 |
Abnormal renal function | 35 344 (8.9) | 19 855 (7.2) | 15 489 (12.4) | 17.2 | 30 544 (8.6) | 4800 (11.1) | 8.5 | 34 653 (8.8) | 691 (9.2) | 1.1 | 33 374 (8.8) | 1970 (9.8) | 3.6 |
Modifiable risk factors | |||||||||||||
Smoker | 41 307 (10.3) | 26 117 (9.5) | 15 190 (12.1) | 8.3 | 36 788 (10.3) | 4519 (10.4) | 0.4 | 40 712 (10.4) | 595 (7.9) | −8.7 | 39 386 (10.4) | 1921 (9.6) | −2.6 |
Obesity | 60 134 (15.1) | 38 312 (14.0) | 21 822 (17.4) | 9.4 | 52 982 (14.9) | 7152 (16.5) | 4.5 | 59 088 (15.1) | 1046 (13.9) | −3.5 | 56 831 (15.0) | 3303 (16.5) | 4.2 |
Alcohol‐related diagnoses | 27 438 (6.9) | 16 316 (6.0) | 11 122 (8.9) | 11.1 | 23 986 (6.7) | 3452 (8.0) | 4.8 | 26 976 (6.9) | 462 (6.1) | −3.1 | 25 825 (6.8) | 1613 (8.1) | 4.8 |
Sleep apnea syndrome | 22 752 (5.7) | 14 456 (5.3) | 8296 (6.6) | 5.7 | 20 037 (5.6) | 2715 (6.3) | 2.7 | 22 326 (5.7) | 426 (5.6) | −0.2 | 21 496 (5.7) | 1256 (6.3) | 2.6 |
Anemia | 113 132 (28.3) | 63 363 (23.1) | 65 535 (52.3) | 63.0 | 108 026 (30.3) | 20 872 (48.3) | 37.3 | 126 743 (32.3) | 2155 (28.6) | −8.2 | 121 047 (31.9) | 7851 (39.2) | 15.3 |
Denutrition | 59 919 (15.0) | 37 815 (13.8) | 22 104 (17.6) | 10.5 | 54 524 (15.3) | 5395 (12.5) | −8.2 | 59 094 (15.1) | 825 (10.9) | −12.4 | 57 544 (15.2) | 2375 (11.9) | −9.7 |
Bleeding risk scores | |||||||||||||
HAS‐BLED score | 2.5±1.2 | 2.1±1.0 | 3.4±1.0 | 127.5 | 2.4±1.1 | 3.6±1.0 | 109.0 | 2.5±1.2 | 3.5±1.0 | 95.3 | 2.5±1.1 | 3.5±1.0 | 98.7 |
HAS‐BLED score ≥3 | 195 516 (49.0) | 90 653 (33.1) | 104 863 (83.6) | 119.4 | 157 667 (44.3) | 37 849 (87.5) | 102.4 | 188 888 (48.2) | 6628 (87.9) | 93.9 | 178 044 (46.9) | 17 472 (87.3) | 95.0 |
ATRIA score | 4.6±2.7 | 3.8±2.5 | 6.3±2.5 | 101.8 | 4.3±2.6 | 7.0±2.3 | 107.6 | 4.6±2.7 | 5.8±2.5 | 46.3 | 4.5±2.7 | 6.7±2.5 | 84.9 |
ATRIA score ≥5 | 186 308 (46.7) | 97 184 (35.5) | 89 124 (71.1) | 76.4 | 150 725 (42.3) | 35 583 (82.3) | 90.4 | 181 860 (46.4) | 4448 (59.0) | 25.3 | 170 800 (45.0) | 15 508 (77.4) | 70.5 |
ORBIT score | 2.6±1.8 | 1.7±1.3 | 4.4±1.2 | 213.5 | 2.3±1.7 | 4.8±1.1 | 174.2 | 2.5±1.8 | 4.0±1.2 | 97.2 | 2.5±1.8 | 4.6±1.2 | 142.6 |
ORBIT score ≥4 | 122 960 (30.8) | 30 576 (11.2) | 92 384 (73.7) | 163.3 | 86 082 (24.2) | 36 878 (85.3) | 155.4 | 118 552 (30.3) | 4408 (58.4) | 59.1 | 107 072 (28.2) | 15 888 (79.3) | 119.4 |
AF indicates atrial fibrillation; ATRIA, anemia, severe renal disease (eg, dialysis), age ≥75 years, prior bleeding, and hypertension; CABG, coronary artery bypass grafting; CHA2DS2‐VASc congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female); COPD, chronic obstructive pulmonary disease; GB, gastrointestinal bleeding; HAS‐BLED, uncontrolled hypertension (systolic blood pressure >160 mm Hg), abnormal kidney (dialysis or transplant)/liver function (ie, cirrhosis), previous stroke, bleeding history or predisposition, elderly age (≥65 years), and drug (antiplatelet, nonsteroidal anti‐inflammatory drugs)/alcohol abuse; ICH, intracranial hemorrhage; ORBIT, older age ≥75 years, anemia, bleeding history, chronic kidney disease, and treatment with antiplatelet drugs; and PCI, percutaneous coronary intervention.