Table 1.
Baseline characteristics - Modified intention-to-treat cohort
| Rivaroxaban (n=26) |
Standard-of-care (n=27) |
Total (n=53) | |
|---|---|---|---|
|
| |||
| Demographics | |||
|
| |||
| Age | |||
| Median, IQR (years) | 48.5 (37.0 – 64.25) | 48.0 (39.0 – 58.0) | 48.0 (38.5 – 73.2) |
| Range (years) | 19 – 74 | 21 – 86 | 19 – 86 |
| 18–29 (N, %) | 4 (15.4) | 4 (14.8) | 8 (15.1) |
| 30–39 (N, %) | 3 (11.5) | 3 (11.1) | 6 (11.3) |
| 40–49 (N, %) | 6 (23.1) | 7 (25.9) | 13 (24.5) |
| 50–59 (N, %) | 4 (15.4) | 7 (25.9) | 11 (20.8) |
| 60–69 (N, %) | 6 (23.1) | 2 (7.4) | 8 (15.1) |
| ≥70 | 3 (11.5) | 4 (14.8) | 7 (13.2) |
|
| |||
| Female Sex (N, %) | 18 (69.2) | 17 (63.0) | 35 (66.0) |
|
| |||
| Self-identified race-ethnicity (N, %) | |||
| white | 16 (61.5) | 15 (55.5) | 31 (58.5) |
| East Asian | 5 (19.2) | 1 (3.7) | 6 (11.3) |
| South Asian | 1 (3.8) | 3 (11.1) | 4 (7.5) |
| Indigenous | 1 (3.8) | 1 (3.7) | 2 (3.8) |
| Other | 2 (7.7) | 7 (25.9) | 9 (17.0) |
| Missing | 1 (3.8) | 0 (0.0) | 1 (1.9) |
|
| |||
| Risk factors (N, %) | |||
|
| |||
| Prior VTE | 3 (12.0) | 0 (0.0) | 3 (5.8) |
|
| |||
| Active cancer | 0 (0.0) | 1 (3.7) | 1 (1.9) |
|
| |||
| Known thrombophilia | 0 (0.0) | 0 (0.0) | 0 (0.0) |
|
| |||
| Recent infection (within last month) | 6 (23.1) | 3 (11.1) | 9 (17.0) |
|
| |||
| Oral contraceptive use | 7 (26.9) | 8 (29.6) | 16 (30.2) |
| Other hormonal contraceptive | 1 (3.8) | 0 (0.0) | 1 (1.9) |
|
| |||
| Hormone replacement therapy | 0 (0.0) | 1 (3.7) | 1 (1.9) |
|
| |||
| Post-partum (6 months or less) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
|
| |||
| Surgery in the last six weeks | 2 (7.7) | 1 (3.7) | 3 (5.7) |
|
| |||
| Dehydration in last 7 days | 1 (3.8) | 3 (11.1) | 4 (7.5) |
|
| |||
| Inflammatory bowel disease | 0 (0.0) | 0 (0.0) | 0 (0.0) |
|
| |||
| Family history of VTE | 2 (7.7) | 2 (7.4) | 4 (7.5) |
|
| |||
| Presentation | |||
|
| |||
| Symptom onset to enrollment, days | |||
| Median (IQR) | 8.0 (6.75 – 14.0) | 9.0 (3 – 14.0) | 8.0 (4.5 – 14.0) |
|
| |||
| Diagnosis to enrollment, days, Median (IQR) | 4.0 (2 – 6) | 3.0 (1 – 7) | 3.0 (2 – 6) |
| Range | 1 – 14 | 1 – 12 | 1 – 14 |
| Received bridging anticoagulation prior to randomization (N, %) | 25 (96.2) | 26 (96.3) | 51 (96.2) |
| UFH | 9 (34.6) | 12 (44.4) | 21 (39.6) |
| LMWH | 12 (46.2) | 9 (34.6) | 21 (39.6) |
| UFH + LMWH | 2 (7.7) | 4 (14.8) | 6 (11.3) |
| LMWH + Oral anticoagulant | 2 (7.7) | 1 (3.7) | 3 (5.7) |
| No lead-in anticoagulation | 1 (3.8) | 1 (3.7) | 2 (3.8) |
|
| |||
| Presenting symptoms, N(%) | |||
| Headache | 23 (88.5) | 24 (88.9) | 47 (88.7) |
| Focal sensory | 5 (19.2) | 8 (28.6) | 13 (24.5) |
| Nausea/vomiting | 13 (50.0) | 14 (51.9) | 27 (50.9) |
| Visual loss/blurring | 7 (26.9) | 7 (25.9) | 14 (26.4) |
| Diplopia | 6 (23.1) | 1 (3.7) | 7 (13.2) |
| Language disturbance | 6 (23.1) | 7 (25.9) | 13 (24.5) |
| Cognitive dysfunction/encephalopathy | 10 (38.5) | 9 (33.3) | 19 (35.8) |
| Focal motor | 9 (34.6) | 8 (29.6) | 17 (32.1) |
| Seizure | 13 (50.0) | 10 (37.0) | 23 (43.4) |
| Tinnitus | 4 (15.4) | 4 (14.8) | 8 (15.1) |
|
| |||
| NIHSS Median (IQR) | 0 (0 – 1) | 0 (0 – 1) | 0 (0 – 1) |
| 0 (N, %) | 15 (57.7) | 18 (66.7) | 33 (62.3) |
| 1–4 | 7 (26.9) | 7 (25.9) | 14 (26.4) |
| 5–9 | 4 (15.4) | 2 (7.4) | 6 (11.3) |
|
| |||
| Baseline neuroimaging characteristics | |||
|
| |||
| Baseline imaging modality (N, %) | N=26 | N=27 | N=53 |
| CT/CTV | 20 (76.9) | 23 (85.2) | 43 (81.1) |
| MR/MRV | 6 (23.1) | 4 (14.8) | 11 (20.8) |
|
| |||
| Venous edema or venous infarct (N, %) |
N=25 8 (32.0) |
N=26 8 (30.1) |
N=51 16 (31.4) |
|
| |||
| Intracranial hemorrhage (N, %) | N=25 | N=26 | N=51 |
| Any | 13 (52) | 8 (30.8) | 21 (41.2) |
| HI1 | 1 (4) | 0 (0) | 1 (2.0) |
| HI2 | 1 (4) | 3 (11.5) | 4 (7.8) |
| PH1 | 5 (20) | 2 (7.7) | 7 (13.7) |
| PH2 | 2 (8) | 1 (3.8) | 3 (5.9) |
| 3c (subarachnoid) | 4 (16) | 2 (7.7) | 6 (11.8) |