From: Rivaroxaban treatment for asymptomatic venous thromboembolism: insights from the J’xactly study
Asymptomatic PE with/without DVT | Asymptomatic DVT | |||||||
Total | Occurred clinical events | Not occurred clinical events | P-value | Total | Occurred clinical events | Not occurred clinical events | P-value | |
Clinically relevant events | n = 197 | n = 25 | n = 172 | n = 203 | n = 33 | n = 170 | ||
Age (years) | 65 ± 14 | 67 ± 14 | 65 ± 15 | 0.47 | 72 ± 12 | 74 ± 11 | 71 ± 12 | 0.28 |
≥ 75 years | 58 (29.4%) | 7 (28.0%) | 51 (29.7%) | 1.00 | 88 (43.3%) | 17 (51.5%) | 71 (41.8%) | 0.34 |
Female | 94 (47.7%) | 11 (44.0%) | 83 (48.3%) | 0.83 | 151 (74.4%) | 24 (72.7%) | 127 (74.7%) | 0.49 |
Body weight (kg) | 62.7 ± 13.8 | 61.3 ± 13.5 | 62.9 ± 13.8 | 0.60 | 55.5 ± 11.6 | 51.0 ± 10.5 | 56.3 ± 11.8 | 0.017 |
< 50 kg | 33 (16.8%) | 7 (28.0%) | 26 (15.1%) | 0.15 | 63 (31.0%) | 15 (45.5%) | 48 (28.2%) | 0.06 |
CrCL (mL/minute) | 84.5 ± 33.8 | 83.7 ± 37.3 | 84.7 ± 33.3 | 0.90 | 72.9 ± 28.4 | 67.8 ± 31.4 | 73.9 ± 27.7 | 0.26 |
< 50 mL/minute | 29 (14.7%) | 4 (16.0%) | 25 (14.5%) | 0.77 | 47 (23.2%) | 13 (39.4%) | 34 (20.0%) | 0.025 |
Diabetes mellitus | 27 (13.7%) | 1 (4.0%) | 26 (15.1%) | 0.21 | 28 (13.8%) | 3 (9.1%) | 25 (14.7%) | 0.58 |
Chronic heart and lung disease | 7 (3.6%) | 3 (12.0%) | 4 (2.3%) | 0.045 | 9 (4.4%) | 3 (9.1%) | 6 (3.5%) | 0.16 |
Active cancer | 54 (27.4%) | 14 (56.0%) | 40 (23.3%) | 0.001 | 55 (27.1%) | 18 (54.5%) | 37 (21.8%) | < 0.001 |
D-dimer (µg/mL) | 9.3 (5.3–17.5) | 9.5 (6.3–16.1) | 9.1 (5.1–17.5) | 0.65 | 6.6 (2.9–11.9) | 7.1 (3.4–11.1) | 6.4 (2.7–12.3) | 0.40 |
Initial rivaroxaban treatment | ||||||||
Treatment duration, days | ||||||||
Median (IQR) | 361 (165–630) | 222 (107–319) | 406 (173–647) | 0.002 | 106 (68–259) | 170 (100–388) | 99 (55–223) | 0.030 |
Recurrence or aggravation of symptomatic VTE | n = 197 | n = 6 | n = 191 | n = 203 | n = 6 | n = 197 | ||
Age (years) | 65 ± 14 | 60 ± 17 | 65 ± 14 | 0.35 | 70 ± 12 | 72 ± 10 | 70 ± 12 | 0.81 |
≥ 75 years | 58 (29.4%) | 1 (16.7%) | 57 (29.8%) | 0.67 | 134 (42.1%) | 3 (37.5%) | 131 (42.3%) | 1.00 |
Female | 94 (47.7%) | 4 (66.7%) | 90 (47.1%) | 0.43 | 220 (69.2%) | 6 (75.0%) | 214 (69.0%) | 1.00 |
Body weight (kg) | 62.7 ± 13.7 | 70.0 ± 14.0 | 62.4 ± 13.7 | 0.18 | 57.3 ± 12.6 | 55.7 ± 13.5 | 57.3 ± 12.6 | 0.72 |
< 50 kg | 33 (16.8%) | 1 (16.7%) | 32 (16.8%) | 1.00 | 90 (28.3%) | 4 (50.0%) | 86 (27.7%) | 0.23 |
CrCL (mL/minute) | 84.5 ± 33.8 | 114.4 ± 44.0 | 83.6 ± 33.1 | 0.027 | 72.9 ± 28.4 | 67.5 ± 33.3 | 73.1 ± 28.3 | 0.64 |
< 50 mL/minute | 29 (14.9%) | 0 (0.0%) | 29 (15.3%) | 0.59 | 69 (22.0%) | 3 (37.5%) | 66 (21.6%) | 0.38 |
Diabetes mellitus | 27 (13.7%) | 0 (0.0%) | 27 (14.1%) | 1.00 | 41 (12.9%) | 1 (12.5%) | 40 (12.9%) | 1.00 |
Chronic heart and lung disease | 7 (3.6%) | 0 (0.0%) | 7 (3.7%) | 1.00 | 17 (5.4%) | 1 (12.5%) | 16 (5.2%) | 0.36 |
Active cancer | 51 (25.9%) | 1 (16.7%) | 50 (26.2%) | 1.00 | 75 (23.6%) | 2 (25.0%) | 73 (23.6%) | 1.00 |
D-dimer (µg/mL) | 9.3 (5.3–17.5) | 8.0 (5.1–9.3) | 9.3 (5.2–17.5) | 0.30 | 7.9 (3.5–14.2) | 10.7 (3.1–16.5) | 7.8 (3.5–14.2) | 0.60 |
Initial rivaroxaban treatment | ||||||||
Treatment duration, days | ||||||||
Median (IQR) | 361 (165–630) | 216 (80–477) | 362 (166–630) | 0.37 | 106 (68–259) | 170 (147–321) | 173 (85–514) | 0.82 |
Major bleeding | n = 197 | n = 4 | n = 193 | n = 203 | n = 6 | n = 197 | ||
Age (years) | 65 ± 14 | 55 ± 19 | 65 ± 14 | 0.16 | 70 ± 12 | 72 ± 10 | 70 ± 12 | 0.72 |
≥ 75 years | 58 (29.4%) | 0 (0.0%) | 58 (30.1%) | 0.32 | 134 (42.1%) | 3 (37.5%) | 131 (42.3%) | 1.00 |
Female | 94 (47.7%) | 3 (75.0%) | 91 (47.2%) | 0.35 | 220 (69.2%) | 5 (62.5%) | 215 (69.4%) | 0.71 |
Body weight (kg) | 62.7 ± 13.8 | 54.9 ± 13.5 | 62.8 ± 13.8 | 0.26 | 57.3 ± 12.6 | 54.3 ± 8.5 | 57.4 ± 12.7 | 0.50 |
< 50 kg | 33 (16.8%) | 2 (50.0%) | 31 (16.1%) | 0.13 | 90 (28.3%) | 1 (12.5%) | 89 (28.7%) | 0.45 |
CrCL (mL/minute) | 84.5 ± 33.8 | 111.9 ± 58.6 | 84.0 ± 33.1 | 0.10 | 72.9 ± 28.4 | 63.1 ± 18.7 | 73.2 ± 28.6 | 0.39 |
< 50 mL/minute | 29 (14.9%) | 0 (0.0%) | 29 (15.2%) | 1.00 | 69 (22.0%) | 2 (25.0%) | 67 (21.9%) | 0.69 |
Diabetes mellitus | 27 (13.7%) | 0 (0.0%) | 27 (14.0%) | 1.00 | 41 (12.9%) | 1 (12.5%) | 40 (12.9%) | 1.00 |
Chronic heart and lung disease | 7 (3.6%) | 1 (25.0%) | 6 (3.1%) | 0.14 | 17 (5.4%) | 0 (0.0%) | 17 (5.5%) | 1.00 |
Active cancer | 54 (27.4%) | 0 (0.0%) | 54 (28.0%) | 0.58 | 75 (23.6%) | 4 (50.0%) | 71 (22.9%) | 0.09 |
D-dimer (µg/mL) | 9.3 (5.3–17.5) | 10.3 (9.5–15.4) | 9.1 (5.2–17.5) | 0.53 | 7.9 (3.5–14.2) | 7.1 (2.7–23.7) | 7.9 (3.6–14.2) | 0.96 |
Initial rivaroxaban treatment | ||||||||
Treatment duration, days | ||||||||
Median (IQR) | 361 (165–630) | 236 (41–371) | 362 (168–631) | 0.18 | 106 (68–259) | 294 (38–595) | 173 (86–514) | 0.92 |