Table I.
Baseline patient characteristics and outcomes for all patients and by OAC (prior to matching)
| Variables | All patients | Apixaban | Dabigatran | Rivaroxaban | Warfarin |
|---|---|---|---|---|---|
| Sample size | 34,569 | 1,350 | 3,435 | 8,597 | 11,187 |
| Age (y) mean (SD) | 71.2 (10.7) | 72.3 (10.5) | 67.2 (11.1) | 69.4 (11.0) | 72.8 (9.8) |
| CHADS2VASC, mean (SD)* | |||||
| 0 | 553 (1.6) | 139 (1.2) | 106 (3.1) | 217 (2.5) | 91 (0.8) |
| 1 | 1,880 (5.4) | 548 (4.8) | 330 (9.6) | 649 (7.5) | 353 (3.2) |
| 2 | 3,604 (10.4) | 1,131 (10.0) | 532 (15.5) | 1,174 (13.7) | 767 (6.9) |
| 3+ | 28,532 (82.5) | 9,532 (84.0) | 2,467 (71.8) | 6,557 (76.3) | 9,976 (89.2) |
| HASBLED, mean (SD)† | |||||
| 0 | 679 (2.0) | 196 (1.7) | 128 (3.7) | 232 (2.7) | 123 (1.1) |
| 1 | 3,400 (9.8) | 999 (8.8) | 558 (16.2) | 1,112 (12.9) | 731 (6.5) |
| 2 | 8,348 (24.1) | 2,685 (23.7) | 954 (27.8) | 2,355 (27.4) | 2,354 (21.0) |
| 3 | 10,342 (29.9) | 3,382 (29.8) | 974 (28.4) | 2,527 (29.4) | 3,459 (30.9) |
| 4 | 7,510 (21.7) | 2,576 (22.7) | 547 (15.9) | 1,571 (18.3) | 2,816 (25.2) |
| 5 | 3,320 (9.6) | 1,147 (10.1) | 230 (6.7) | 637 (7.4) | 1,306 (11.7) |
| 6 | 845 (2.4) | 327 (2.9) | 35 (1.0) | 139 (1.6) | 344 (3.1) |
| 7 | 119 (0.3) | 36 (0.3) | NA | 23 (0.3) | 53 (0.5) |
| US region, n (%) | |||||
| Midwest | 5,825 (16.9) | 1,922 (16.9) | 439 (12.8) | 1,288 (15.0) | 2,176 (19.5) |
| Northeast | 6,046 (17.5) | 1,912 (16.8) | 558 (16.2) | 1,586 (18.4) | 1,990 (17.8) |
| South | 19,306 (55.8) | 6,498 (57.3) | 2,091 (60.9) | 4,840 (56.3) | 5,877 (52.5) |
| West | 3,392 (9.8) | 1,018 (9.0) | 347 (10.1) | 883 (10.3) | 1,144 (10.2) |
| Race, n (%) | |||||
| Asian | 867 (2.5) | 261 (2.3) | 96 (2.8) | 272 (3.2) | 238 (2.1) |
| Black | 3,483 (10.1) | 1,246 (11.0) | 272 (7.9) | 719 (8.4) | 1,246 (11.1) |
| Hispanic | 2,259 (6.5) | 714 (6.3) | 212 (6.2) | 621 (7.2) | 712 (6.4) |
| White | 25,051 (72.5) | 7,987 (70.4) | 2,614 (76.1) | 6,287 (73.1) | 8,163 (73.0) |
| Other | 2,909 (8.4) | 1,142 (10.1) | 241 (7.0) | 698 (8.1) | 828 (7.4) |
| Gender: female, n (%) | 14,916 (43.1) | 5,376 (47.4) | 1,251 (36.4) | 3,427 (39.9) | 4,862 (43.5) |
| Medical conditions, n (%) | |||||
| Heart failure (HF) | 13,076 (37.8) | 4,227 (37.2) | 1,010 (29.4) | 2,637 (30.7) | 5,202 (46.5) |
| Hypertension (HTN) | 32,141 (93.0) | 10,560 (93.0) | 3,104 (90.4) | 7,865 (91.5) | 10,612 (94.9) |
| Thromboembolism (Thrombo) | 7,707 (22.3) | 2,562 (22.6) | 623 (18.1) | 1,535 (17.9) | 2,987 (26.7) |
| Diabetes mellitus | 14,817 (42.9) | 4,747 (41.8) | 1,346 (39.2) | 3,435 (40.0) | 5,289 (47.3) |
| Coronar y artery disease (CAD) | 19,548 (56.5) | 6,312 (55.6) | 1,822 (53.0) | 4,393 (51.1) | 7,021 (62.8) |
| Peripheral artery disease (PAD) | 5,240 (15.2) | 1,640 (14.4) | 396 (11.5) | 1,079 (12.6) | 2,125 (19.0) |
| History of major bleeding | 8,544 (24.7) | 2,773 (24.4) | 804 (23.4) | 1,920 (22.3) | 3,047 (27.2) |
| History of intracranial bleeding | 729 (2.1) | 256 (2.3) | 66 (1.9) | 131 (1.5) | 276 (2.5) |
| Liver disease | 5,424 (15.7) | 1,874 (16.5) | 522 (15.2) | 1,328 (15.4) | 1,700 (15.2) |
| Alcoholism | 1,946 (5.6) | 623 (5.5) | 184 (5.4) | 517 (6.0) | 622 (5.6) |
| Obesity | 12,013 (34.8) | 4,214 (37.1) | 1,125 (32.8) | 3,082 (35.8) | 3,592 (32.1) |
| Smoke | 12,109 (35.0) | 4,208 (37.1) | 1,058 (30.8) | 2,952 (34.3) | 3,891 (34.8) |
| Falls | 5,257 (15.2) | 1,955 (17.2) | 362 (10.5) | 1,117 (13.0) | 1,823 (16.3) |
| Acute kidney injury (AKI) | 6,391 (18.5) | 2,186 (19.3) | 365 (10.6) | 1,098 (12.8) | 2,742 (24.5) |
| Other valvular heart disease (VHD) | 17,378 (50.3) | 5,700 (50.2) | 1,711 (49.8) | 4,081 (47.5) | 5,886 (52.6) |
| Nonskin cancer | 7,083 (20.5) | 2,344 (20.7) | 618 (18.0) | 1,578 (18.4) | 2,543 (22.7) |
| Recent major bleeding | 219 (0.6) | 60 (0.5) | 21 (0.6) | 29 (0.3) | 109 (1.0) |
| Recent thromboembolism | 1,912 (5.5) | 598 (5.3) | 134 (3.9) | 329 (3.8) | 851 (7.6) |
| Hyperlipidemia | 30,961 (89.6) | 10,113 (89.1) | 3,074 (89.5) | 7,624 (88.7) | 10,150 (90.7) |
| Ischemic stroke | 5,416 (15.7) | 1,837 (16.2) | 412 (12.0) | 1,019 (11.9) | 2,148 (19.2) |
| Myocardial infarction (MI) | 6,703 (19.4) | 2,115 (18.6) | 519 (15.1) | 1,371 (15.9) | 2,698 (24.1) |
| COPD | 5,741 (16.6) | 1,755 (15.5) | 456 (13.3) | 1,295 (15.1) | 2,235 (20.0) |
| Obstructive sleep apnea | 7,904 (22.9) | 2,690 (23.7) | 853 (24.8) | 2,051 (23.9) | 2,310 (20.6) |
| Systolic heart failure (HF) | 5,319 (15.4) | 1,850 (16.3) | 349 (10.2) | 999 (11.6) | 2,121 (19.0) |
| Cardioversion | 4,070 (11.8) | 1,530 (13.5) | 505 (14.7) | 1,127 (13.1) | 908 (8.1) |
| Ablation | 987 (2.9) | 313 (2.8) | 162 (4.7) | 288 (3.4) | 224 (2.0) |
| Pacemaker/ICD | 4,558 (13.2) | 1,581 (13.9) | 384 (11.2) | 991 (11.5) | 1,602 (14.3) |
| PCI/CABG | 6,793 (19.7) | 2,081 (18.3) | 571 (16.6) | 1,365 (15.9) | 2,776 (24.8) |
| Depression | 13,273 (38.4) | 4,550 (40.1) | 1,203 (35.0) | 3,144 (36.6) | 4,376 (39.1) |
| Dementia | 2,497 (7.2) | 939 (8.3) | 154 (4.5) | 493 (5.7) | 911 (8.1) |
| Hypothyroidism | 11,469 (33.2) | 3,863 (34.0) | 1,095 (31.9) | 2,690 (31.3) | 3,821 (34.2) |
| Thyrotoxicosis | 1,853 (5.4) | 586 (5.2) | 212 (6.2) | 450 (5.2) | 605 (5.4) |
| Ulcer in upper GI tract | 2,159 (6.2) | 697 (6.1) | 204 (5.9) | 475 (5.5) | 783 (7.0) |
| Medications, n (%) | |||||
| Antiplatelet | 4,237 (12.3) | 1,386 (12.2) | 364 (10.6) | 916 (10.7) | 1,571 (14.0) |
| NSAIDS | 4,077 (11.8) | 1,376 (12.1) | 444 (12.9) | 1,047 (12.2) | 1,210 (10.8) |
| Amiodarone | 4,022 (11.6) | 1,367 (12.0) | 364 (10.6) | 857 (10.0) | 1,434 (12.8) |
| Dronedarone | 928 (2.7) | 296 (2.6) | 169 (4.9) | 268 (3.1) | 195 (1.7) |
| Other antiarrhythmic drugs (OAAD) | 3,564 (10.3) | 1,264 (11.1) | 484 (14.1) | 1,041 (12.1) | 775 (6.9) |
| Digoxin | 3,200 (9.3) | 821 (7.2) | 371 (10.8) | 669 (7.8) | 1,339 (12.0) |
| Diltiazem | 6,153 (17.8) | 2,064 (18.2) | 626 (18.2) | 1,533 (17.8) | 1,930 (17.3) |
| Verapamil | 613 (1.8) | 161 (1.4) | 68 (2.0) | 152 (1.8) | 232 (2.1) |
| Other rate control drugs (ORC) | 22,733 (65.8) | 7,630 (67.2) | 2,171 (63.2) | 5,515 (64.2) | 7,417 (66.3) |
| Renin-angiotensin system | |||||
| Renin-angiotensin system antagonists (ACE/ARB) | 18,577 (53.7) | 6,201 (54.6) | 1,816 (52.9) | 4,488 (52.2) | 6,072 (54.3) |
| Other calcium channel blockers (CCB) | 7,934 (23.0) | 2,704 (23.8) | 721 (21.0) | 1,864 (21.7) | 2,645 (23.6) |
| Other adrenergic blocking (Obeta) | 2,012 (5.8) | 608 (5.4) | 184 (5.4) | 437 (5.1) | 783 (7.0) |
| Loop diuretics | 8,582 (24.8) | 2,831 (24.9) | 649 (18.9) | 1,718 (20.0) | 3,384 (30.2) |
| Thiazides | 8,053 (23.3) | 2,692 (23.7) | 858 (25.0) | 1,956 (22.8) | 2,547 (22.8) |
| Cholesterol-lowering drugs (Statins) | 17,950 (51.9) | 6,089 (53.6) | 1,704 (49.6) | 4,257 (49.5) | 5,900 (52.7) |
| Insulin | 2,842 (8.2) | 894 (7.9) | 233 (6.8) | 574 (6.7) | 1,141 (10.2) |
| Metformin | 5,289 (15.3) | 1,731 (15.3) | 523 (15.2) | 1,366 (15.9) | 1,669 (14.9) |
| Other diabetes mellitus drugs (Odiab) | 4,538 (13.1) | 1,468 (12.9) | 426 (12.4) | 1,050 (12.2) | 1,594 (14.2) |
| Antiulcer agents (Antiulcer) | 9,233 (26.7) | 3,189 (28.1) | 774 (22.5) | 2,034 (23.7) | 3,236 (28.9) |
| eGFR groups, n (%) | |||||
| 15–30 | 1,060 (3.1) | 327 (2.9) | 39 (1.1) | 111 (1.3) | 583 (5.2) |
| 30–45 | 3,433 (9.9) | 1,213 (10.7) | 222 (6.5) | 607 (7.1) | 1,391 (12.4) |
| 45–60 | 6,716 (19.4) | 2,278 (20.1) | 594 (17.3) | 1,523 (17.7) | 2,321 (20.7) |
| 60–90 | 18,037 (52.2) | 5,916 (52.1) | 1,877 (54.6) | 4,764 (55.4) | 5,480 (49.0) |
| 90+ | 5,323 (15.4) | 1,616 (14.2) | 703 (20.5) | 1,592 (18.5) | 1,412 (12.6) |
| Outcomes, n (%) | |||||
| Major bleeding | 1,068 (3.1) | 239 (2.1) | 68 (2.0) | 246 (2.9) | 515 (4.6) |
| All-cause mortality | 1,675 (4.8) | 365 (3.2) | 152 (4.4) | 306 (3.6) | 852 (7.6) |
| Primary composite | 2,110 (6.1) | 471 (4.1) | 193 (5.6) | 381 (4.4) | 1,065 (9.5) |
| Follow-up time (mo), mean (SD) | |||||
| Follow up major bleeding | 8.1 (8.9) | 7.7 (7.7) | 8.8 (10.8) | 8.2 (9.0) | 8.2 (9.4) |
| Follow-up all-cause mortality | 8.7 (9.7) | 7.9 (7.8) | 9.6 (11.9) | 8.6 (9.4) | 9.2 (10.7) |
| Follow-up primary composite | 8.1 (9.0) | 7.7 (7.7) | 8.8 (10.8) | 8.3 (9.0) | 8.3 (9.5) |
| Mean follow-up, all outcomes | 8.3 (9.0) | 7.7 (7.7) | 9.0 (10.9) | 8.4 (9.0) | 8.6 (9.5) |
CABG, coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; eGFR, glomerular filtration rate; GI, gastrointestinal; ICD, implantable cardioverter-defibrillator; NA, counts that are less than 10, and we masked those cells in accordance with OptumLabs data use policy; NSAID, nonsteroidal anti-inflammatory drug; PCI, percutaneous coronary intervention.
Unless otherwise noted, data are presented as n (%) for categorical variables and mean (SD) for continuous variables.
*
The CHADS2VASC score ranges from 0 to 9; higher score indicates higher risk of stroke. A point score is calculated as 1 point each for heart failure, hypertension, diabetes mellitus, vascular disease, age 65 to 74 years, and female sex; 2 points for age ≥75 y and prior stroke, TIA, or thromboembolism.
†
The HASBLED score ranges from 0 to 9; higher score indicates higher risk of bleeding. A point score is calculated as 1 point each for hypertension, abnormal kidney function, abnormal liver function, prior stroke, prior bleeding or bleeding predisposition, labile international normalized ratio (INR), older than 65 years, medication usage predisposing to bleeding, and alcohol use. This study did not consider INR, so the range of HASBLED was 0 to 8.