Table 1.
Characteristics of Patients at Start of Follow-Up (N = 3,082)
| Characteristic | VKAa (n = 1,946) | DOACa (n = 1,136) | P | Totala (N = 3,082) |
|---|---|---|---|---|
| Age | ||||
| Mean (SD), y | 75.0 (11.5) | 73.3 (12.3) | <.001 | 74.4 (11.8) |
| ≥75 years, No. (%) | 1,138 (58.5) | 599 (52.7) | .002 | 1,737 (56.4) |
| Male, No. (%) | 1,095 (56.3) | 594 (52.3) | .03 | 1,689 (54.8) |
| Weight, mean (SD), kg | 80.1 (18.0) | 78.9 (17.7) | .08 | 79.7 (17.9) |
| Body mass index | ||||
| Mean (SD), kg/m2 | 28.8 (5.8) | 28.4 (5.6) | .13 | 28.6 (5.7) |
| >30 kg/m2, No. (%) | 576 (35.7) | 336 (34.9) | .68 | 912 (35.4) |
| Medical history, No. (%) | ||||
| Hypertension | 1,367 (70.3) | 757 (66.6) | .04 | 2,124 (68.9) |
| DVT and/or PE | 467 (24.0) | 186 (16.4) | <.001 | 653 (21.2) |
| Diabetes mellitus | 469 (24.1) | 253 (22.3) | .25 | 722 (23.4) |
| Coronary heart disease and/or MI | 393 (20.2) | 156 (13.7) | <.001 | 549 (17.8) |
| Symptomatic heart failure | 336 (17.3) | 141 (12.4) | <.001 | 477 (15.5) |
| Stroke and/or TIA | 303 (15.6) | 172 (15.1) | .75 | 475 (15.4) |
| Peripheral arterial disease | 220 (11.3) | 101 (8.9) | .03 | 321 (10.4) |
| Bleeding requiring hospitalization | 146 (7.5) | 54 (4.8) | .003 | 200 (6.5) |
| Cancer | 65 (3.3) | 27 (2.4) | .13 | 92 (3.0) |
| Timed Up and Go test as estimated by GP, No. (%)b | <.001 | |||
| <14 seconds | 1,022 (52.5) | 695 (61.2) | 1,717 (55.7) | |
| 14-30 seconds | 473 (24.3) | 238 (21.0) | 711 (23.1) | |
| >30 seconds | 229 (11.8) | 108 (9.5) | 337 (10.9) | |
| CHA2DS2-VASc score, No. (%)c,d | .007 | |||
| 0 | 20 (1.2) | 29 (2.9) | 49 (1.9) | |
| 1 | 98 (6.1) | 65 (6.5) | 163 (6.2) | |
| ≥2 | 1,499 (92.7) | 900 (90.5) | 2,399 (91.9) | |
| HAS-BLED score, No. (%)c,e | <.001 | |||
| ≤3 | 1,293 (80.0) | 883 (88.8) | 2,176 (83.3) | |
| >3 | 324 (20.0) | 111 (11.2) | 435 (16.7) | |
| Renal failure (clearance), No. (%) | .07 | |||
| None (≥60 mL/min) | 1,317 (67.7) | 805 (70.9) | 2,122 (68.9) | |
| Moderate (30-60 mL/min) | 513 (26.4) | 257 (22.6) | 770 (25.0) | |
| Severe (15-30 mL/min) | 19 (1.0) | 7 (0.6) | 26 (0.8) | |
| Terminal (<15 mL/min) | 1 (0.1) | 0 (0) | 1 (0) | |
| Hepatic function, No. (%) | .04 | |||
| AST and/or ALT >3N and/or bilirubin >2N | 12 (0.6) | 2 (0.2) | 14 (0.5) | |
| AST and/or ALT <3N and bilirubin <2N | 1,434 (73.7) | 875 (77.0) | 2,309 (74.9) | |
| Indication for anticoagulation, No. (%) | .001 | |||
| Nonvalvular atrial fibrillation | 1,619 (83.2) | 994 (87.5) | 2,613 (84.8) | |
| Treatment of DVT/PE | 327 (16.8) | 142 (12.5) | 469 (15.2) | |
| Anticoagulant, No. (%) | … | |||
| Acenocoumarol | 113 (5.8) | … | 113 (3.7) | |
| Apixaban | … | 66 (5.8) | 66 (2.1) | |
| Dabigatran | … | 440 (38.7) | 440 (14.3) | |
| Fluindione | 1,397 (71.8) | … | 1,397 (45.3) | |
| Rivaroxaban | … | 630 (55.5) | 630 (20.4) | |
| Warfarin | 436 (22.4) | … | 436 (14.1) | |
| Number of concomitant medications with risk for interaction, No. (%)f | .82 | |||
| None | 798 (41.0) | 478 (42.1) | 1,276 (41.4) | |
| 1 | 795 (40.9) | 452 (39.8) | 1,247 (40.5) | |
| ≥2 | 353 (18.1) | 206 (18.1) | 559 (18.1) | |
| Duration of anticoagulant treatment >1 year, No. (%) | 1,446 (74.3) | 582 (51.3) | <.001 | 2,028 (65.8) |
| Patient adherence as perceived by GP | .10 | |||
| Not or not very adherent | 103 (5.4) | 76 (6.8) | 179 (5.9) | |
| Rather or completely adherent | 1,820 (94.6) | 1,041 (93.2) | 2,861 (94.1) |
2N = 2 times the upper limit of normal; 3N = 3 times the upper limit of normal; ALT = alanine aminotransferase; AST = aspartate aminotransferase; CHA2DS2-VASc = congestive heart failure, hypertension, age (>75 = 2 points), diabetes, previous stroke/transient ischemic attack (2 points)–vascular; DOAC = direct oral anticoagulants; DVT = deep vein thrombosis; GP = general practitioner; HAS-BLED = hypertension, abnormal liver/renal function, stroke history, bleeding history or predisposition, labile international normalized ratio, elderly, drug/alcohol use; MI = myocardial infarction; NSAID = nonsteroidal anti-inflammatory drug; PE = pulmonary embolism; TIA = transient ischemic attack; VKA = vitamin K antagonist.
Denominators may be less than shown in column heads because of missing data for some characteristics.
Longer time indicates poorer mobility.
Calculated for 2,611 patients with nonvalvular atrial fibrillation.
Scores range from 0 to 9; higher scores indicate greater stroke risk.
Scores range from 0 to 9; higher scores indicate greater risk for major bleeding.
Concomitant medications from medical records were statins, amiodarone, antiplatelet agents, serotonin reuptake inhibitors, fibrate, verapamil, NSAIDs, quinidine, carbamazepine, tacrolimus, cyclosporine, anticoagulants, systemic antifungal agents, rifampicin, protease inhibitors.