Table 2:
Treatment variables
MISTIE (n=250) |
Medical (n=249) |
p value | |
---|---|---|---|
Ictus to randomisation time (hours) | 47 (33–60) | 46 (36–58) | 0·817 |
Ictus to end of treatment (EOT) time (hours)* | 123 (104–150) | 115 (103–127) | <0·0001 |
MISTIE procedure duration (hours) | 1 (1–1) | NA | NA |
Number of alteplase doses | 4 (2–6) | NA | NA |
EOT CT | |||
ICH volume (mL) | 12·5 (7·6–21·0)† | 43·7 (33·6–56·3)† | <0·0001 |
IVH volume (mL) | 0·2 (0–1·5) | 0·3 (0–1·9) | 0·137 |
EOT ICH remaining ≤15 mL | 148 (59·7%) | 2 (0·8%) | <0·0001 |
Withdrawal of care | 26 (10·4%) | 35 (14·1%) | 0·213 |
Days in ICU | 10 (7–17) | 10 (5–16) | 0·460 |
Days to return home | 55 (34–105) | 62 (35–100) | 0·846 |
ICP events monitored | |||
% subjects with any ICP ≥20 mm Hg | 34 (13·6%) | 38 (15·3%) | 0·598 |
% subjects with any CPP <70 mm Hg | 9/34 (26·5%) | 22/38 (57·9%) | 0·007 |
% ICP readings ≥20 mm Hg† | 23/690 (3·3%) | 67/711 (9·4%) | 0·01 |
% CPP readings <70 mm Hg† | 64/690 (9·3%) | 159/711 (22·4%) | 0·04 |
One or more ICP therapies | 25/34 (73·5%) | 26/38 (68·4%) | 0·634 |
Data are median (IQR), mean (SD), or n/N (%). NA=not applicable. ICH=intracerebral haemorrhage. IVH=intraventricular haemorrhage. ICU=intensive care unit. ICP=intracranial pressure. CPP=cerebral perfusion pressure.
End of treatment time calculated as 24 h after last dose for patients in the MISTIE group who received alteplase and as the sum of randomisation time plus median surgical end of treatment time for patients in the standard medical care group. This achieved a virtual dosing endpoint without alteplase dosing for each individual patient in the standard medical care groups.
Adjusted for number of readings per patient.
Data were available for 240 patients in the MISTIE group and 238 patients in the standard medical care group. Additional outcome variable data are included in the appendix.