Table 3.
Patient-reported and functional outcomes*
| Outcome, mean (SD) or median (IQR) | Baseline, N completing assessment | Day 180, N | Day 365, N | |||||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| Rivaroxaban (N=26) | Standard-of-care (N=27) | Rivaroxaban (N=25) | Standard-of-care (N=26) | Rivaroxaban (N=24) | Standard-of-care (N=25) | |||
|
| ||||||||
| mRS, median (IQR) n(%), | n=24 2 (1 – 3) |
n=27 2 (1 – 2.5) |
n=24 1 (0 – 2) |
n=26 1 (0 – 1) |
n=23 1 (0 – 1) |
n=25 1 (0 – 1) |
||
| 0 | 2 (8.3) | 6 (21.4) | 9 (37.5) | 10 (38.5) | 10 (43.5) | 12 (48.0) | ||
| 1 | 6 (25.0) | 7 (25.9) | 8 (33.3) | 11 (42.3) | 9 (39.1) | 9 (36.0) | ||
| 2 | 9 (37.5) | 8 (29.6) | 7 (29.2) | 5 (19.2) | 3 (13.0) | 2 (8.0) | ||
| 3 | 6 (25.0) | 5 (18.5) | 0 | 0 | 1 (4.3) | 1 (4.0) | ||
| 4 | 0 (0.0) | 1 (3.7) | 0 | 0 | 0 | 0 (0.0) | ||
| 5 | 1 (4.2) | 0 (0.0) | 0 | 0 | 0 | 0 (0.0) | ||
| 6 | 0 (0.0) | 0 (0.0) | 0 | 0 | 0 | 1 (4.0) | ||
|
| ||||||||
| Rivaroxaban | Standard-of-care | Rivaroxaban | Standard-of-care |
Difference in proportions, %
(95% CI) |
Rivaroxaban | Standard-of-care | Difference in proportions, % (95% CI)> | |
|
| ||||||||
| mRS 0–1, (N, %) | 8 (33.3) | 13 (47.3) | 17 (70.8) | 21 (80.8) | −10 (−37.0 – 9.1) | 19 (82.6) | 21 (84.0) | −1.4 (−22.5 – 19.7) |
| mRS shift for baseline mRS>0 (N, %) | – | – | 17/21 (81.0) | 14/21 (66.7) | 14.3 (−12.0 – 41.0) | 17/20 (85.0) | 16/20 (80.0) | 5.0 (−18.1 – 28.5) |
|
| ||||||||
|
| ||||||||
| Rivaroxaban | Standard-of-care | Rivaroxaban | Standard-of-care | Mean difference, change from baseline to d180, rivaroxaban v control, 95% CI | Rivaroxaban | Standard-of-care | Mean difference, change from baseline to d365, rivaroxaban v control, 95% CI | |
|
| ||||||||
| EQ5D-5L, N | 22 | 27 | 22 | 25 | 0.01 (−0.08 –0.09) | 20 | 23 | −0.02 (−0.15 – 0.1) |
| Mean (SD) | 0.76 (0.16) | 0.73 (0.17) | 0.89 (0.07) | 0.89 (0.09) | 0.87 (0.10) | 0.85 (0.15) | ||
| Median (IQR) | 0.77 (0.65 – 0.89) | 0.79 (0.59 – 0.89) | 0.91 (0.87 – 0.95) | 0.93 (0.82 – 0.95) | 0.9 (0.84 – 0.95) | 0.9 (0.85 – 0.95) | ||
|
| ||||||||
| PHQ-9, N | 21 | 27 | 21 | 25 | −2.55 (−5.46 – 0.36) | 19 | 23 | −2.3 (−5.96 – 1.35) |
| Mean (SD) | 6.52 (4.05) | 9.15 (5.68) | 3.81 (4.24) | 3.80 (4.28) | 4.68 (5.16) | 4.57 (3.79) | ||
| Median (IQR) | 6.0 (4 – 9) | 9.0 (5 – 13) | 3.0 (0 – 6) | 3.0 (0 – 6) | 3.0 (0 – 8) | 4.0 (2 – 6) | ||
|
| ||||||||
| HIT-6, N | 20 | 27 | 21 | 25 | 0.9 (−5.83 – 7.63) | 19 | 23 | 4.13 (−2.81 – 11.08) |
| Mean (SD) | 59.70 (9.63) | 56.78 (11.85) | 47.00 (9.72) | 44.08 (9.53) | 43.53 (7.80) | 20.48 (7.42) | ||
| Median (IQR) | 60.5 (58 – 64) | 58.0 (49 – 67) | 48.0 (36 – 54) | 40.0 (36 – 51) | 41.0 (36 – 50) | 20.0 (15 – 23) | ||
|
| ||||||||
| FAS, N | 19 | 24 | 21 | 25 | −1.72 (−8.02 – 4.57) | 20 | 23 | 0.29 (−6.71 – 7.29) |
| Mean (SD) | 23.21 (9.16) | 25.83 (10.01) | 18.57 (7.43) | 19.72 (7.29) | 18.10 (6.66) | 20.48 (7.42) | ||
| Median (IQR) | 22.0 (16 – 32) | 24.5 (17 – 32) | 17.0 (12 – 24) | 19.0 (13 – 25) | 16.5 (36 – 49) | 20.0 (15 – 23) | ||
|
| ||||||||
| MoCA, N | 17 | 24 | 15 | 16 | 1.64 (−1.54 – 4.82) | 14 | 15 | 1.59 (−1.1 – 4.27) |
| Mean (SD) | 24.71 (3.55) | 22.88 (3.83) | 25.4 (5.12) | 26.13 (3.07) | 26.93 (1.87) | 28.36 (1.50) | ||
| Median (IQR) | 25 (23 – 28) | 24.5 (21 – 26) | 26 (25 – 28) | 27 (25 – 28) | 27 (26 – 28) | 29 (27.75 – 29.25) | ||
| <26, N(%) | 10 (58.8) | 16 (66.7) | 5 (33.3) | 5 (31.1) | 2 (13.3) | 1 (7.1) | ||
*
Summaries involving change in scores from baseline are based on participants with both baseline and follow-up scores.