Patient characteristics on entrance into the PT period or Fiix period and at the end of the study
| . | PT period (12 mo) . | Fiix period (12 mo) . | Active patients at end of study . |
|---|---|---|---|
| Patients | 2363 (100) | 1796 (100) | 1409 (100) |
| Age at beginning of period, median (IQR), y | 76 (66-83) | 76 (67-84) | 76 (68-84) |
| Males | 1418 (60) | 1092 (61) | 865 (61) |
| White | >99% | >99% | >99% |
| Years of warfarin treatment, median (IQR) | 5.7 (2.3-10.8) | 7.0 (3.1-12.2) | NA |
| Intended treatment <6 mo | 76 (3) | 42 (2) | NA |
| Normalized ratio target range | |||
| 2-3 | 2166 (92) | 1616 (90) | 1265 (90) |
| 2.5-3.5 | 146 (6) | 123 (7) | 102 (7) |
| 1.5-2.5 | 53 (2) | 56 (3) | 42 (3) |
| Main indication for warfarin | |||
| AF, all | 1353 (57) | 993 (55) | 807 (57) |
| Prior cerebral infarction | 276 (20) | 191 (19) | 158 (20) |
| CHA2DS2-VASC score, median (IQR) | 3 (2-4) | 3 (2-4) | 3 (2-4) |
| Ischemic heart disease | 51 (2) | 39 (2) | 33 (2) |
| Congestive heart failure | 13 (1) | 9 (1) | 8 (1) |
| Atrial septal defect | 5 (<0.5) | 2 (<0.5) | 2 (<0.5) |
| Prosthetic heart valve | 132 (6) | 116 (6) | 100 (7) |
| Valvular heart disease | 17 (1) | 10 (1) | 8 (1) |
| Cerebral TE or TIA (without AF) | 133 (6) | 105 (6) | 82 (6) |
| Peripheral arterial TE | 16 (1) | 15 (1) | 8 (1) |
| VTE | 612 (26) | 481 (27) | 343 (24) |
| Deep vein thrombosis | 286 (12) | 235 (13) | 158 (11) |
| Pulmonary embolism | 326 (14) | 246 (14) | 185 (13) |
| Other indication | 33 (1) | 26 (1) | 18 (1) |
| Associated conditions | |||
| Hypertension | 664 (28) | 514 (29) | 406 (29) |
| Ischemic heart disease | 455 (19) | 335 (19) | 253 (18) |
| Other atherosclerosis | 108 (5) | 80 (4) | 61 (4) |
| Congestive heart failure | 529 (22) | 408 (23) | 334 (24) |
| Diabetes | 210 (9) | 165 (9) | 132 (9) |
| History of cancer | 302 (13) | 243 (14) | 201 (14) |
| Renal failure | 177 (7) | 148 (8) | 119 (8) |
| Prior cerebral infarction or TIA | 507 (21) | 351 (20) | 282 (20) |
| Cerebral infarction | 356 (15) | 243 (14) | 203 (14) |
| TIA | 151 (6) | 108 (6) | 79 (6) |
| . | PT period (12 mo) . | Fiix period (12 mo) . | Active patients at end of study . |
|---|---|---|---|
| Patients | 2363 (100) | 1796 (100) | 1409 (100) |
| Age at beginning of period, median (IQR), y | 76 (66-83) | 76 (67-84) | 76 (68-84) |
| Males | 1418 (60) | 1092 (61) | 865 (61) |
| White | >99% | >99% | >99% |
| Years of warfarin treatment, median (IQR) | 5.7 (2.3-10.8) | 7.0 (3.1-12.2) | NA |
| Intended treatment <6 mo | 76 (3) | 42 (2) | NA |
| Normalized ratio target range | |||
| 2-3 | 2166 (92) | 1616 (90) | 1265 (90) |
| 2.5-3.5 | 146 (6) | 123 (7) | 102 (7) |
| 1.5-2.5 | 53 (2) | 56 (3) | 42 (3) |
| Main indication for warfarin | |||
| AF, all | 1353 (57) | 993 (55) | 807 (57) |
| Prior cerebral infarction | 276 (20) | 191 (19) | 158 (20) |
| CHA2DS2-VASC score, median (IQR) | 3 (2-4) | 3 (2-4) | 3 (2-4) |
| Ischemic heart disease | 51 (2) | 39 (2) | 33 (2) |
| Congestive heart failure | 13 (1) | 9 (1) | 8 (1) |
| Atrial septal defect | 5 (<0.5) | 2 (<0.5) | 2 (<0.5) |
| Prosthetic heart valve | 132 (6) | 116 (6) | 100 (7) |
| Valvular heart disease | 17 (1) | 10 (1) | 8 (1) |
| Cerebral TE or TIA (without AF) | 133 (6) | 105 (6) | 82 (6) |
| Peripheral arterial TE | 16 (1) | 15 (1) | 8 (1) |
| VTE | 612 (26) | 481 (27) | 343 (24) |
| Deep vein thrombosis | 286 (12) | 235 (13) | 158 (11) |
| Pulmonary embolism | 326 (14) | 246 (14) | 185 (13) |
| Other indication | 33 (1) | 26 (1) | 18 (1) |
| Associated conditions | |||
| Hypertension | 664 (28) | 514 (29) | 406 (29) |
| Ischemic heart disease | 455 (19) | 335 (19) | 253 (18) |
| Other atherosclerosis | 108 (5) | 80 (4) | 61 (4) |
| Congestive heart failure | 529 (22) | 408 (23) | 334 (24) |
| Diabetes | 210 (9) | 165 (9) | 132 (9) |
| History of cancer | 302 (13) | 243 (14) | 201 (14) |
| Renal failure | 177 (7) | 148 (8) | 119 (8) |
| Prior cerebral infarction or TIA | 507 (21) | 351 (20) | 282 (20) |
| Cerebral infarction | 356 (15) | 243 (14) | 203 (14) |
| TIA | 151 (6) | 108 (6) | 79 (6) |
Unless otherwise indicated, data are shown as n (%). Percentages may not total 100% owing to the presence of >1 indication in some patients or rounding of numbers.
CHA2DS2-VASC score, congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or TIA or thromboembolism, vascular disease; NA, not applicable.