Cohorts (%) | Patients | Total number of outcome events/ Person-years | Median number per cohort (range) | Outcome event incidence (95% CI) per 100 person-years | ||
---|---|---|---|---|---|---|
All cohorts | Follow-up, person-years | 63 (100) | 3424 | – | 72 (1.7–1020) | – |
Composite outcome* | 32 (51) | 1568 | 313/5169 | 3 (0–108) | 6.1 (5.4–6.8) | |
Deaths attributable to CCM or treatment | 63 (100) | 3424 | 28/10029 | 0 (0–4) | 0.3 (0.2–0.4) | |
Deaths not attributed to CCM or treatment | 61 (97) | 3228 | 18/9348 | 0 (0–4) | 0.2 (0.1–0.3) | |
Symptomatic ICH | 43 (68) | 2465 | 160/8331 | 1 (0–32) | 1.9 (1.6–2.2) | |
Persistent FND | 42 (67) | 2123 | 201/6290 | 2 (0–82) | 3.2 (2.8–3.7) | |
Neurosurgery cohorts | Follow-up, person-years | 49 (100) | 2684 | – | 48 (1.7–1020) | – |
Composite outcome | 21 (43) | 1100 | 198/3021 | 2 (0–108) | 6.6 (5.7–7.5) | |
Deaths attributable to CCM or treatment | 49 (100) | 2684 | 18/6707 | 0 (0–4) | 0.3 (0.2–0.4) | |
Deaths not attributed to CCM or treatment | 48 (98) | 2613 | 7/6701 | 0 (0–4) | 0.1 (0.05–0.2) | |
Symptomatic ICH | 29 (59) | 1725 | 53/5008 | 1 (0–22) | 1.1 (0.8–1.4) | |
Persistent FND | 31 (63) | 1655 | 176/4143 | 2 (0–82) | 4.3 (3.7–4.9) | |
Stereotactic radiosurgery cohorts | Follow-up, person-years | 14 (100) | 740 | – | 160 (24.9–675) | – |
Composite outcome | 11 (79) | 468 | 115/2147 | 5 (1–35) | 5.4 (4.5–6.4) | |
Deaths attributable to CCM or treatment | 14 (100) | 740 | 10/3322 | 0 (0–2) | 0.3 (0.2–0.6) | |
Deaths not attributed to CCM or treatment | 13 (93) | 615 | 11/2647 | 0 (0–3) | 0.4 (0.2–0.8) | |
Symptomatic ICH | 14 (100) | 740 | 107/3322 | 5 (0–32) | 3.2 (2.7–3.9) | |
Persistent FND | 11 (79) | 468 | 25/2147 | 2 (0–6) | 1.2 (0.8–1.7) |
*Composite outcome consisted of death, non-fatal symptomatic ICH or non-fatal new or worse non-haemorrhagic persistent FND attributed to CCM or its treatment.
CCM, cerebral cavernous malformation; ICH, intracranial haemorrhage; FND, focal neurological deficit; CI, confidence interval.