Table 3.
Safety endpoints and intracranial haemorrhage subtypes
| Trevo group (n=88) | Merci group (n=90) | Odds ratio (95% CI) | p value* | |
|---|---|---|---|---|
| Primary safety endpoint | ||||
| Composite events | 13 (15%) | 21 (23%) | 0·57 (0·26–1·22) | 0·1826 |
| Device-related (potential or definite) | 8 (9%) | 16 (18%) | 0·46 (0·19–1·14) | 0·1238 |
| Device-related (potential or definite): neurologically significant | 3 (3%) | 4 (4%) | 0·76 (0·16–3·49) | 1·0000 |
| Device-related (definite) | 2 (2%) | 6 (7%) | 0·33 (0·06–1·66) | 0·2780 |
| Device-related (definite): neurologically significant | 0 | 1 (1%) | 0·0 (NA) | 1·0000 |
| Vessel perforation | 1 (1%) | 9 (10%) | 0·10 (0·01–0·83) | 0·0182 |
| Intramural arterial dissection | 0 | 1 (1%) | 0·0 (NA) | 1·0000 |
| Symptomatic intracranial haemorrhage (ECASS III definition)† | 6 (7%) | 8 (9%) | 0·75 (0·25–2·26) | 0·7820 |
| Embolisation to previously uninvolved territory | 6 (7%) | 4 (4%) | 1·57 (0·43–578) | 0·5334 |
| Access-site complication requiring surgical repair or blood transfusion | 2 (2%) | 1 (1%) | 2·07 (0·18–23·25) | 0·6186 |
| Death within 24 h | 2 (2%) | 0 | ∞ (NA) | 0·2430 |
| In-vivo device failure | 0 | 0 | NA | 1·0000 |
| Other PRAE | 0 | 0 | NA | 1·0000 |
| Secondary safety endpoints | ||||
| Death by day 90 | 29 (33%) | 21 (24%) | 1·61 (0·83–3·13) | 0·1845 |
| Neurological deterioration at 24 h‡ | 14 (16%) | 20 (22%) | 0·66 (0·31–1·41) | 0·3418 |
| Haemorrhage categories | ||||
| Asymptomatic intracranial haemorrhage at 24 h | 36 (41%) | 48 (53%) | 0·61 (0·33–1·10) | 0·1017 |
| Symptomatic intracranial haemorrhage (SITS-MOST criteria)§ | 4 (4%) | 2 (2%) | 2·09 (0·37–1174) | 0·4411 |
| PH-1 (any) | 13 (15%) | 19 (21%) | 0·65 (0·30–1·40) | 0·3304 |
| PH-1 (device-related) | 0 | 1 (1%) | 0·00 (0·00–19·43) | 1·0000 |
| PH-2 (any) | 7 (8%) | 5 (6%) | 1·47 (0·45–4·82) | 0·5642 |
| PH-2 (device-related) | 1 (1%) | 1 (1%) | 1·02 (0·01–81·19) | 1·0000 |
| SAH (any) | 11 (12%) | 21 (23%) | 0·47 (0·21–1·04) | 0·0786 |
| SAH (device-related) | 7 (8%) | 17 (19%) | 0·37 (0·12–1·01) | 0·0469 |
ECASS=European Cooperative Acute Stroke Study. NA=not applicable. PRAE=procedure-related adverse event. SITS-MOST=Safe Implementation of Thrombolysis in Stroke Monitoring Study. PH=parenchymal haemorrhage. SAH=subarachnoid hemorrhage. NIHSS=National Institutes of Health Stroke Scale.
Fisher’s exact test.
Any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the NIHSS, or that led to death and was identified as the predominant cause of the neurological deterioration.
≥4 point increase compared with baseline in the NIHSS at 24 h.
Local or remote PH-2 on the imaging scan obtained at 24 (18–36) h, plus neurological deterioration as indicated by a score on the NIHSS that was higher by ≥4 points than the baseline value, or the lowest value between baseline and 24 h, or haemorrhage leading to death.