TABLE 3.
Clinical characteristics, treatment and outcome
| Re‐exposure analyses (n = 42) a | |||||||
|---|---|---|---|---|---|---|---|
| Patients with CSVT (n = 46) | Re‐exposed to ASP (n = 31) | Non‐re‐exposed to ASP (n = 11) | |||||
| n/N | % | n/N | % | n/N | % | p‐Value | |
| Neurological status at diagnosis | |||||||
| Seizures | 17/43 | 40 | 14/29 | 48 | 2/11 | 18 | 0.08 |
| Affected consciousness | 13/45 | 29 | 8/30 | 27 | 3/11 | 27 | 0.97 |
| Visual disturbance and/or papilloedema | 4/34 | 12 | 1/21 | 5 | 3/11 | 27 | 0.07 |
| Headache | 27/43 | 63 | 17/29 | 59 | 8/11 | 72 | 0.41 |
| Nausea/vomiting | 12/43 | 28 | 10/29 | 34 | 2/11 | 18 | 0.32 |
| Motor difficulties | 16/43 | 37 | 11/29 | 38 | 4/11 | 36 | 0.93 |
| Modified Rankin Scale, median, IQR | (2) | (1–4) | (2) | (1–2.75) | (3) | (1.8–3.25) | 0.14 |
| Imaging at diagnosis | |||||||
| Parenchymal lesions | 16/36 | 44 | 11/23 | 48 | 3/10 | 30 | 0.34 |
| Bilateral lesions | 7/34 | 21 | 4/21 | 19 | 1/10 | 10 | 0.52 |
| Oedema | 8/35 | 23 | 6/23 | 26 | 0 | 0.09 | |
| Haemorrhage | 11/36 | 31 | 6/23 | 26 | 3/10 | 30 | 0.82 |
| ≥1 venous infarction | 8/35 | 23 | 6/22 | 27 | 1/10 | 10 | 0.27 |
| CSVT score | |||||||
| 1 point | 11/39 | 28 | 8/27 | 30 | 2/9 | 22 | 0.13 |
| 2 points | 7/39 | 18 | 7/27 | 26 | 0 | ||
| 3–4 points | 15/39 | 38 | 10/27 | 37 | 4/9 | 44 | |
| >4 points | 6/39 | 15 | 2/27 | 7 | 3/9 | 33 | |
| Treatment | |||||||
| Days on any antithrombotic treatment, median, IQR | (232) | (183–403) | (240) | (184–408) | (280) | (175–662) | 0.72 |
| Truncation of ASP after CSVT | |||||||
| ≥1 ASP dose omitted | 37/44 | 84 | 25/31 | 81 | 11/11 | 100 | 0.12 |
| Number of ASP doses omitted, median, IQR | (2.5) | (1–6.75) | (2) | (1–5) | (6) | (4–8) | <0.01 |
| ≥1 intrathecal treatment omitted | 14/43 | 33 | 9/30 | 30 | 4/11 | 36 | 0.7 |
| Outcome at follow‐up | |||||||
| Follow‐up (years), median, IQR b | (4.5) | (2.8–7.4) | (4.6) | (2.8–6.8) | (7.9) | (3.3–9.5) | 0.43 |
| Major bleeding during antithrombotic treatment, no. (IR) | 4/46 | (0.10) | 1/31 | (0.039) | 1/11 | (0.079) | 0.66 |
| Epilepsy treatment ongoing | 4/41 | 10 | 4/30 | 13 | 0 | 0.56 | |
| Visual disturbance | 1/41 | 2 | 1/31 | 3 | 0 | 1 | |
| Headache | 3/40 | 8 | 2/29 | 7 | 1/10 | 10 | 1 |
| Motor difficulties | 3/41 | 7 | 2/30 | 7 | 1/10 | 10 | 1 |
| Modified Rankin Scale, median, IQR | (0) | (0–1) | (0) | (0–1) | (0) | (0–2) | 0.57 |
| Imaging at follow‐up | |||||||
| Recanalisation | |||||||
| No recanalisation | 1/35 | 3 | 1/23 | 4 | 0 | 0.48 | |
| Grade I: partial | 10/35 | 29 | 6/23 | 26 | 3/10 | 30 | |
| Grade II: complete of ≥1 | 4/35 | 11 | 1/23 | 4 | 2/10 | 20 | |
| Grade III: complete of all | 20/35 | 57 | 15/23 | 65 | 5/10 | 50 | |
| CSVT score at follow‐up | |||||||
| No thrombosis, 0 points | 19/31 | 61 | 14/21 | 67 | 5/9 | 56 | 0.43 |
| 1 point | 9/31 | 29 | 6/21 | 29 | 2/9 | 22 | |
| 2 points | 2/31 | 6 | 1/21 | 5 | 1/9 | 11 | |
| 3–4 points | 1/31 | 3 | 0 | 1/9 | 11 | ||
Abbreviations: ASP, asparaginase; CSVT, cerebral sinovenous thrombosis; IQR, interquartile range; IR, incidence rate.
Four patients were excluded from the analysis: death shortly after diagnosis (n = 3) and already received all ASP doses (n = 1), p‐value: simple statistical test of differences between re‐exposed and non‐re‐exposed (no adjustments were applied because of the small sample size), n: number of patients with CSVT, N: number of patients with CSVT and available data, IR is the incidence rate per year at risk. Motor difficulties: trouble walking, impaired function of arms/hands. Infarction is defined as dead tissue visible in the scan in an area related to cerebral thrombosis. Major bleeding was defined according to Schulman and Kearon [24].
The maximal follow‐up defined as the last day of follow‐up at the local centre. Recanalisation was defined according to Qureshi [28].