TABLE 1.
Baseline characteristics of oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (AF) subjects with a CHA2DS2-VASc score of ≥ 1 in men or ≥ 2 in women.
| Patient characteristics | VKA (n = 56,610) | NOAC |
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| Overall (n = 221,172) | Dabigatran (n = 29,492) | Rivaroxaban (n = 77,023) | Apixaban (n = 79,176) | Edoxaban (n = 35,481) | ||
| Age (years) | 73.1 ± 11.3 | 77.2 ± 9.4 | 76.7 ± 9.2 | 76.7 ± 9.4 | 78.0 ± 9.3 | 77.1 ± 9.6 |
| < 65 years | 14,043 (24.8%) | 19,569 (8.8%) | 2804 (9.5%) | 7280 (9.5%) | 6142 (7.8%) | 3343 (9.4%) |
| 65–74 years | 16,157 (28.5%) | 66,950 (30.3%) | 9168 (31.1%) | 24,101 (31.3%) | 22,444 (28.3%) | 11,237 (31.7%) |
| 75–84 years | 17,645 (31.2%) | 85,594 (38.7%) | 11,763 (39.9%) | 30,127 (39.1%) | 30,769 (38.9%) | 12,935 (36.5%) |
| ≥ 85 years | 8765 (15.5%) | 49,059 (22.2%) | 5757 (19.5%) | 15,515 (20.1%) | 19,821 (25.0%) | 7966 (22.5%) |
| Female | 26,575 (46.9%) | 106,404 (48.1%) | 13,852 (47.0%) | 36,652 (47.6%) | 39,284 (49.6%) | 16,616 (46.8%) |
| Reduced dose | NA | 82,170 (37.2%) | 16,463 (55.8%) | 30,697 (39.9%) | 23,882 (30.2%) | 11,128 (31.4%) |
| Follow-up (years) | 3.7 ± 2.1 | 2.7 ± 1.9 | 3.4 ± 2.1 | 3.3 ± 2.0 | 2.4 ± 1.7 | 1.3 ± 0.9 |
| Comorbidities | ||||||
| Hypertension | 39,183 (69.2%) | 152,277 (68.9%) | 20,006 (67.8%) | 52,305 (67.9%) | 56,070 (70.8%) | 23,895 (67.3%) |
| Coronary artery disease | 15,181 (26.8%) | 39,085 (17.7%) | 4662 (15.8%) | 13,261 (17.2%) | 15,019 (19.0%) | 6143 (17.3%) |
| Congestive heart failure | 10,330 (18.2%) | 34,535 (15.6%) | 3809 (12.9%) | 11,621 (15.1%) | 13,934 (17.6%) | 5170 (14.6%) |
| Valvular heart disease | 12,579 (22.2%) | 27,564 (12.5%) | 3284 (11.1%) | 8619 (11.2%) | 10,993 (13.9%) | 4668 (13.2%) |
| Peripheral artery disease | 7419 (13.1%) | 17,251 (7.8%) | 2090 (7.1%) | 5445 (7.1%) | 7064 (8.9%) | 2651 (7.5%) |
| Dyslipidemia | 34,295 (60.6%) | 127,879 (57.8%) | 17,522 (59.4%) | 43,226 (56.1%) | 46,705 (59.0%) | 20,426 (57.6%) |
| Chronic kidney disease | 9097 (16.1%) | 24,524 (11.1%) | 2002 (6.8%) | 7428 (9.6%) | 10,912 (13.8%) | 4183 (11.8%) |
| Chronic liver disease | 2648 (4.7%) | 7206 (3.3%) | 816 (2.8%) | 2482 (3.2%) | 2673 (3.4%) | 1234 (3.5%) |
| Chronic lung disease | 8509 (15.0%) | 26,967 (12.2%) | 3201 (10.9%) | 9443 (12.3%) | 10,299 (13.0%) | 4024 (11.3%) |
| Obstructive sleep apnea | 2296 (4.1%) | 8270 (3.7%) | 994 (3.4%) | 2788 (3.6%) | 2992 (3.8%) | 1496 (4.2%) |
| Cancer | 5991 (10.6%) | 23,939 (10.8%) | 2729 (9.3%) | 8053 (10.5%) | 8805 (11.1%) | 4352 (12.3%) |
| Upper GI tract disorder | 5192 (9.2%) | 16,139 (7.3%) | 1862 (6.3%) | 5727 (7.4%) | 6339 (8.0%) | 2211 (6.2%) |
| Lower GI tract disorder | 4137 (7.3%) | 16,054 (7.3%) | 1928 (6.5%) | 5483 (7.1%) | 5949 (7.5%) | 2694 (7.6%) |
| Diabetes mellitus | 24,136 (42.6%) | 72,548 (32.8%) | 8685 (29.4%) | 24,253 (31.5%) | 28,011 (35.4%) | 11,598 (32.7%) |
| Thyroid disease | 8711 (15.4%) | 32,698 (14.8%) | 4137 (14.0%) | 11,495 (14.9%) | 12,367 (15.6%) | 4699 (13.2%) |
| Anemia | 6801 (12.0%) | 17,486 (7.9%) | 1777 (6.0%) | 5796 (7.5%) | 7149 (9.0%) | 2764 (7.8%) |
| Osteoporosis | 3951 (7.0%) | 16,315 (7.4%) | 2079 (7.0%) | 5743 (7.5%) | 6017 (7.6%) | 2475 (7.0%) |
| Dementia | 2929 (5.2%) | 12,527 (5.7%) | 1393 (4.7%) | 4330 (5.6%) | 5054 (6.4%) | 1750 (4.9%) |
| Parkinson’s disease | 1631 (2.9%) | 7039 (3.2%) | 918 (3.1%) | 2326 (3.0%) | 2738 (3.5%) | 1057 (3.0%) |
| History of falling | 4255 (7.5%) | 19,083 (8.6%) | 1969 (6.7%) | 5788 (7.5%) | 8141 (10.3%) | 3185 (9.0%) |
| Frailty | 14,480 (25.6%) | 70,711 (32.0%) | 8405 (28.5%) | 22,734 (29.5%) | 28,895 (36.5%) | 10,677 (30.1%) |
| Prior thromboembolism | 9357 (16.5%) | 31,358 (14.2%) | 5472 (18.6%) | 8473 (11.0%) | 13,822 (17.5%) | 3591 (10.1%) |
| Prior MB/CRNMB | 4253 (7.5%) | 12,726 (5.8%) | 1523 (5.2%) | 4018 (5.2%) | 5122 (6.5%) | 2063 (5.8%) |
| Medication history | ||||||
| Number of concomitant drugs | 7.4 ± 4.6 | 6.8 ± 4.2 | 6.4 ± 3.8 | 6.8 ± 4.1 | 7.1 ± 4.4 | 6.7 ± 4.2 |
| Polypharmacy (5–9) | 25,276 (44.6%) | 102,867 (46.5%) | 14,133 (47.9%) | 36,325 (47.2%) | 36,287 (45.8%) | 16,122 (45.4%) |
| Hyperpolypharmacy (≥ 10) | 15,243 (26.9%) | 47,915 (21.7%) | 5178 (17.6%) | 16,136 (20.9%) | 19,313 (24.4%) | 7288 (20.5%) |
| Rate control therapy | 33,766 (59.6%) | 147,739 (66.8%) | 19,352 (65.6%) | 50,533 (65.6%) | 54,041 (68.3%) | 23,813 (67.1%) |
| Beta blockers | 32,062 (56.6%) | 140,018 (63.3%) | 18,322 (62.1%) | 47,560 (61.7%) | 51,349 (64.9%) | 22,787 (64.2%) |
| Verapamil, diltiazem | 2093 (3.7%) | 8554 (3.9%) | 1166 (4.0%) | 3286 (4.3%) | 2982 (3.8%) | 1120 (3.2%) |
| Digoxin | 3679 (6.5%) | 21,587 (9.8%) | 2686 (9.1%) | 7241 (9.4%) | 8264 (10.4%) | 3396 (9.6%) |
| Rhythm control therapy | 13,529 (23.9%) | 72,097 (32.6%) | 9859 (33.4%) | 26,916 (34.9%) | 24,979 (31.5%) | 10,343 (29.2%) |
| Class I AAD | 2926 (5.2%) | 21,065 (9.5%) | 3111 (10.5%) | 8053 (10.5%) | 6549 (8.3%) | 3352 (9.4%) |
| Class III AAD | 11,408 (20.2%) | 56,148 (25.4%) | 7506 (25.5%) | 20,951 (27.2%) | 20,033 (25.3%) | 7658 (21.6%) |
| Antiplatelet | 23,467 (41.5%) | 98,502 (44.5%) | 13,120 (44.5%) | 33,686 (43.7%) | 36,075 (45.6%) | 15,621 (44.0%) |
| Acetylsalicylic acid | 21,770 (38.5%) | 91,410 (41.3%) | 12,247 (41.5%) | 31,470 (40.9%) | 33,381 (42.2%) | 14,312 (40.3%) |
| P2Y12 inhibitor | 3714 (6.6%) | 14,359 (6.5%) | 1736 (5.9%) | 4386 (5.7%) | 5495 (6.9%) | 2742 (7.7%) |
| ACE inhibitor/ARB | 30,107 (53.2%) | 116,668 (52.7%) | 15,474 (52.5%) | 40,726 (52.9%) | 42,270 (53.4%) | 18,198 (51.3%) |
| DHP calcium channel blocker | 18,807 (33.2%) | 70,374 (31.8%) | 9019 (30.6%) | 23,590 (30.6%) | 26,577 (33.6%) | 11,188 (31.5%) |
| Loop diuretic | 20,413 (36.1%) | 65,853 (29.8%) | 7567 (25.7%) | 22,861 (29.7%) | 25,297 (32.0%) | 10,128 (28.5%) |
| Non-loop diuretic | 21,015 (37.1%) | 83,508 (37.8%) | 10,813 (36.7%) | 29,127 (37.8%) | 30,225 (38.2%) | 13,343 (37.6%) |
| Proton pump inhibitor | 25,494 (45.0%) | 90,800 (41.1%) | 11,208 (38.0%) | 30,849 (40.1%) | 33,965 (42.9%) | 14,778 (41.7%) |
| NSAID | 14,819 (26.2%) | 51,687 (23.4%) | 7043 (23.9%) | 18,730 (24.3%) | 17,779 (22.5%) | 8135 (22.9%) |
| Oral corticosteroids | 13,528 (23.9%) | 45,237 (20.5%) | 5438 (18.4%) | 15,952 (20.7%) | 16,438 (20.8%) | 7409 (20.9%) |
| SSRI/SNRI | 7713 (13.6%) | 26,959 (12.2%) | 3460 (11.7%) | 9658 (12.5%) | 10,121 (12.8%) | 3720 (10.5%) |
| Clinical risk score | ||||||
| CHA2DS2-VASc score | 3.6 ± 1.8 | 3.7 ± 1.6 | 3.6 ± 1.6 | 3.5 ± 1.6 | 3.9 ± 1.7 | 3.5 ± 1.6 |
| HAS-BLED score | 2.6 ± 1.3 | 2.6 ± 1.2 | 2.6 ± 1.1 | 2.5 ± 1.1 | 2.7 ± 1.2 | 2.5 ± 1.2 |
| Charlson comorbidity index | 4.5 ± 2.4 | 4.6 ± 2.2 | 4.4 ± 2.1 | 4.4 ± 2.2 | 4.8 ± 2.3 | 4.5 ± 2.3 |
| Prescriber | ||||||
| Primary care physician | 33,162 (58.6%) | 80,888 (36.6%) | 11,146 (37.8%) | 32,035 (41.6%) | 27,350 (34.5%) | 10,358 (29.2%) |
| Cardiologist | 10,601 (18.7%) | 89,477 (40.5%) | 12,218 (41.4%) | 28,980 (37.6%) | 30,998 (39.2%) | 17,282 (48.7%) |
| Other physician | 12,847 (22.7%) | 50,806 (23.0%) | 6128 (20.8%) | 16,008 (20.8%) | 20,828 (26.3%) | 7842 (22.1%) |
Data shown as mean ± standard deviation, or counts and percentages. Incident VKA users included 27,392 acenocoumarol, 15,412 warfarin and 13,806 phenprocoumon users. AAD, antiarrhythmic drug; ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker; CRNMB, clinically relevant non-major bleeding; DHP, dihydropyridine; GI, gastrointestinal; MB, major bleeding; NA, not applicable; NOAC, non-vitamin K antagonist oral anticoagulant; NSAID, non-steroidal anti-inflammatory drug; OAC, oral anticoagulant; SNRI, serotonin and norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; VKA, vitamin K antagonist.