Odds ratio (OR) analysis of haemorrhagic transformation in trials of thrombolytic agents in acute ischaemic stroke
| Trial | All types of haemorrhages | Symptomatic haemorrhages | Fatal haemorrhages | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Agent odds | Placebo odds | OR (agent/placebo) | 95% CI | Agent odds | Placebo odds | OR (agent/placebo) | 95% CI | Agent odds | Placebo odds | OR (agent/placebo) | 95% CI | |||
| ECASS | 134/179 | 113/194 | 1.3 | 0.93–1.77 | 35/278 | 9/298 | 4.2 | 1.97–8.83 | 19/294 | 7/300 | 2.8 | 1.15–6.69 | ||
| NINDS I+II | 34/278 | 11/301 | 3.3 | 1.66–6.73 | 20/292 | 2/310 | 10.6 | 2.46–45.82 | 9/303 | 1/311 | 9.2 | 1.16–73.36 | ||
| MAST-E | 49/88 | 17/116 | 3.8 | 2.04–7.04 | 24/113 | 4/129 | 6.8 | 2.31–20.34 | — | — | — | — | ||
| MAST-I | 39/118 | 16/140 | 2.9 | 1.54–5.44 | 10/147 | 1/155 | 10.5 | 1.33–83.40 | — | — | — | — | ||
| ASK | 56/118 | 28/138 | 2.3 | 1.40–3.92 | 23/151 | 5/161 | 4.9 | 1.82–13.23 | 17/157 | 3/163 | 5.9 | 1.69–20.47 | ||
The response to rt-PA or streptokinase treatment is shown by the OR for different trials. The OR is measured by dividing the odds for a certain outcome event of the rt-PA group (numerator) by the odds for this event of the placebo group (denominator). An OR of 1 means that the thrombolytic agent did not affect the incidence of haemorrhages. If the 95% CI does not cover unity, the incidence of haemorrhages is significantly enhanced or diminished by the treatment. — = not available. In all trials a significant increase in all types of haemorrhages, of symptomatic haemorrhages, and of fatal haemorrhages was found. The NINDS trial showed the highest relative risk for fatal haemorrhages.