Anticoagulation testing, dosing, intensity, and variability
| . | PT-INR period (12 mo) . | Fiix-NR period (12 mo) . | P . | Proportional change from PT to Fiix period (%) . |
|---|---|---|---|---|
| Patients analyzed, n | 1997 | 1437 | NA | NA |
| Monitoring tests and intervals | ||||
| Monitoring tests, n (%) | 29 018 (100) | 17 895 (100) | NA | |
| Within target range | 18 665 (64) | 11 084 (62) | NA | |
| Below target range | 5 799 (20) | 3 430 (19) | NA | |
| Above target range | 4 544 (16) | 3 430 (19) | NA | |
| Annual tests per patient | 17 (12-24) | 13 (9-18) | <.0001 | −24 |
| Patient testing interval, d | 20 (15-29) | 27 (20-39) | <.0001 | +35 |
| Patient normalized ratios | 2.47 (2.30-2.65) | 2.50 (2.30-2.70) | .0580 | 0 |
| Patient PT-INR or Fiix-NR range | 1.80 (1.20-2.60) | 1.60 (1.10-2.30) | <.0001 | −16 |
| Patient’s normalized ratio between test variability (VGR) | ||||
| All patients: any target | 0.15 (0.06-0.30) | 0.10 (0.04-0.21) | <.0001 | −33 |
| 2.5-3.5 | 0.30 (0.11-0.58) | 0.15 (0.07-0.36) | .0017 | −50 |
| 2-3 | 0.15 (0.06-0.30) | 0.10 (0.04-0.20) | <.0001 | −33 |
| 1.5-2.5 | 0.05 (0.03-0.12) | 0.04 (0.02-0.18) | .8340 | −20 |
| Patient’s TTR | ||||
| Any target range | 77 (65-88) | 79 (67-89) | .0157 | +3 |
| 2.5-3.5 | 70 (53-83) | 71 (58-82) | .8518 | +1 |
| 2-3 | 77 (65-88) | 79 (68-89) | .0067 | +3 |
| 1.5-2.5 | 88 (77-98) | 86 (74-100) | .7339 | −2 |
| Dosing | ||||
| Patient daily dose | 4.5 (3.2-6.1) | 4.4 (3.1-6.1) | .1820 | −2 |
| Patient dose range | 0.71 (0.15-1.57) | 0.43 (0.00-1.00) | <.0001 | −39 |
| Patient annual dose adjustments | 5.0 (1.1-10.3) | 3.3 (0.0-7.1) | <.0001 | −34 |
| Patient dose-adjustment interval, d | 64 (32-172) | 95 (46-289) | <.0001 | +48 |
| . | PT-INR period (12 mo) . | Fiix-NR period (12 mo) . | P . | Proportional change from PT to Fiix period (%) . |
|---|---|---|---|---|
| Patients analyzed, n | 1997 | 1437 | NA | NA |
| Monitoring tests and intervals | ||||
| Monitoring tests, n (%) | 29 018 (100) | 17 895 (100) | NA | |
| Within target range | 18 665 (64) | 11 084 (62) | NA | |
| Below target range | 5 799 (20) | 3 430 (19) | NA | |
| Above target range | 4 544 (16) | 3 430 (19) | NA | |
| Annual tests per patient | 17 (12-24) | 13 (9-18) | <.0001 | −24 |
| Patient testing interval, d | 20 (15-29) | 27 (20-39) | <.0001 | +35 |
| Patient normalized ratios | 2.47 (2.30-2.65) | 2.50 (2.30-2.70) | .0580 | 0 |
| Patient PT-INR or Fiix-NR range | 1.80 (1.20-2.60) | 1.60 (1.10-2.30) | <.0001 | −16 |
| Patient’s normalized ratio between test variability (VGR) | ||||
| All patients: any target | 0.15 (0.06-0.30) | 0.10 (0.04-0.21) | <.0001 | −33 |
| 2.5-3.5 | 0.30 (0.11-0.58) | 0.15 (0.07-0.36) | .0017 | −50 |
| 2-3 | 0.15 (0.06-0.30) | 0.10 (0.04-0.20) | <.0001 | −33 |
| 1.5-2.5 | 0.05 (0.03-0.12) | 0.04 (0.02-0.18) | .8340 | −20 |
| Patient’s TTR | ||||
| Any target range | 77 (65-88) | 79 (67-89) | .0157 | +3 |
| 2.5-3.5 | 70 (53-83) | 71 (58-82) | .8518 | +1 |
| 2-3 | 77 (65-88) | 79 (68-89) | .0067 | +3 |
| 1.5-2.5 | 88 (77-98) | 86 (74-100) | .7339 | −2 |
| Dosing | ||||
| Patient daily dose | 4.5 (3.2-6.1) | 4.4 (3.1-6.1) | .1820 | −2 |
| Patient dose range | 0.71 (0.15-1.57) | 0.43 (0.00-1.00) | <.0001 | −39 |
| Patient annual dose adjustments | 5.0 (1.1-10.3) | 3.3 (0.0-7.1) | <.0001 | −34 |
| Patient dose-adjustment interval, d | 64 (32-172) | 95 (46-289) | <.0001 | +48 |
The 12-mo Fiix-NR period was compared with the 12-mo PT period. Only patients on maintenance-phase anticoagulation (after excluding the first 60 d in new patients) are included in the analysis. Patients not showing up for testing for >90 d, as well as those who had <3 tests during the respective period, were excluded. Unless otherwise noted, data are median (IQR). Ranks were compared using the Mann-Whitney U test.
NA, not applicable.