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.
↵a Denominators may be less than shown in column heads because of missing data for some characteristics.
↵b Longer time indicates poorer mobility.
↵c Calculated for 2,611 patients with nonvalvular atrial fibrillation.
↵d Scores range from 0 to 9; higher scores indicate greater stroke risk.
↵e Scores range from 0 to 9; higher scores indicate greater risk for major bleeding.
↵f 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.