Title: Operative intervention in ICH: Results of the International Surgical Trial in Intracerebral Haemorrhage (STICH)
1Operative intervention in ICH Results of the
International Surgical Trial in Intracerebral
Haemorrhage (STICH)
- A David Mendelow,
- Department of Neurosurgery,
- Newcastle upon Tyne, England
- On behalf of the STICH Investigators
- (Lancet January 29th 2005)
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3Question in STICH
- Does a policy of Early Surgery improve outcome
in patients with spontaneous supratentorial
intracerebral haemorrhage compared with a policy
of Initial Conservative Treatment? - Randomisation within 72 hours of ictus
- Surgery within 24 hours of randomisation
4Time since ictus
Median 20 hrs
hrs
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6Primary Outcome(Prognosis Based)
Early Surgery Initial Conservative treatment
Favourable 122 (26.1) 118 (23.8)
Unfavourable 346 (73.9) 378 (76.2)
7Primary Outcome Prognosis Based
8Mortality
Early Surgery Initial Conservative treatment
Alive 304 (63.7) 316 (62.6)
Dead 173 (36.3) 189 (37.4)
9Mortality
10Kaplan Meier Plot of Survival
Early Surgery
Initial Conservative Treatment
11Secondary OutcomeRankin (Prognosis Based)
Early Surgery Initial Conservative treatment
Favourable 152 (32.8) 137 (28.1)
Unfavourable 312 (67.2) 351 (71.9)
12Secondary OutcomeRankin (Prognosis Based)
13Secondary OutcomeBarthel (Prognosis Based)
Early Surgery Initial Conservative treatment
Favourable 124 (26.7) 110 (22.6)
Unfavourable 341 (73.3) 377 (77.4)
14Secondary OutcomeBarthel (Prognosis Based)
15Primary and Secondary Outcome
- The overall result is NEUTRAL
- NOT POSITIVE or NEGATIVE
16Primary and Secondary Outcome
- The overall result is NEUTRAL
- NOT POSITIVE or NEGATIVE
- Can we now use this information to help with
decision making in our patients? - Subgroups
- Pre-specified published in Lancet paper
- Post-hoc IVH and hydrocephalus
- Crossovers
- Meta-analysis
17Primary and Secondary Outcome
- The overall result is NEUTRAL
- NOT POSITIVE or NEGATIVE
- Can we now use this information to help with
decision making in our patients? - Subgroups
- Pre-specified published in Lancet paper
- Post-hoc IVH and hydrocephalus
- Crossovers
- Meta-analysis
18Favours surgery Favours control
Pre- specified subgroup analysis
19Favours surgery Favours control
GCS
Lobar
Depth
Craniotomy
20Conclusions
- While there is no evidence to support a policy of
Early Surgery compared with a policy of
Initial Conservative Treatment in patients with
spontaneous supratentorial intracerebral
haemorrhage (Timing), pre-specified subgroup
analysis has suggested that Superficial
haematomas treated with craniotomy do better with
Early Surgery.
21Primary and Secondary Outcome
- The overall result is NEUTRAL
- NOT POSITIVE or NEGATIVE
- Can we now use this information to help with
decision making in our patients? - Subgroups
- Pre-specified published in Lancet paper
- Post-hoc IVH and hydrocephalus
- Crossovers
- Meta-analysis
22Primary and Secondary Outcome
- The overall result is NEUTRAL
- NOT POSITIVE or NEGATIVE
- Can we now use this information to help with
decision making in our patients? - Subgroups
- Pre-specified published in Lancet paper
- Post-hoc IVH and hydrocephalus DANGER
- Crossovers
- Meta-analysis
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24Post-hoc analysis of IVH and hydrocephalus (All
CT scans read per protocol Neurosurgery Focus
2003)
- Of 902 readable CT scans
- 42 (377) had IVH
- of whom 55 (208) had hydrocephalus.
(Paramasweram Battathiri et al. Ann Arbour 2005)
25- Overall favourable outcomes
- No IVH - 31.4
- IVH - 15.1
- (plt0.00001)
- IVH alone - 19.5
- IVH hydrocephalus - 11.5
- (p0.031)
-
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28Intraventricular haemorrhage (IVH), Hydrocephalus
(HCP), Early Surgery(ES), Initial Conservative
treatment (ICT) Total Number of patients in
that group
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30Intraventricular haemorrhage (IVH), Hydrocephalus
(HCP), Early Surgery(ES), Initial Conservative
treatment (ICT) Total Number of patients in
that group
31Lobar haemorrhages with No IVH and No
Hydrocephalus (prognosis based outcome)
Early surgery Initial Conservative Treatment
Favourable outcome 53 (49) 42 (37) 95
Unfavourable outcome 56 70 126
109 112 221
P0.095
32Lobar haematomas with No IVH and No Hydrocephalus
(prognosis based outcome)
33Primary and Secondary Outcome
- The overall result is NEUTRAL
- NOT POSITIVE or NEGATIVE
- Can we now use this information to help with
decision making in our patients? - Subgroups
- Pre-specified published in Lancet paper
- Post-hoc IVH and hydrocephalus
- Crossovers (26 ICT group)
- Meta-analysis
34Crossovers from intention to treat (ICT Initial
Conservative Treatment)
(M Prasad et al. Ann Arbour 2005)
35Crossovers and GCS in ICT group of 140
crossovers to surgery
- Average drop in GCS at crossover was 3 points
36Volume in ICT group of 140 crossovers to surgery
(in red)
37Depth from cortical surface in ICT group of 140
crossovers (in red)
38Factors that drove crossovers to surgery from
Initial Conservative Treatment (ICT)
- Deterioration in Glasgow Coma Score (GCS)
- Larger volume
- Bigger midline shift
- Superficial
- Focal deficit
- NOT
- IVH
- hydrocephalus
39Primary and Secondary Outcome
- The overall result is NEUTRAL
- NOT POSITIVE or NEGATIVE
- Can we now use this information to help with
decision making in our patients? - Subgroups
- Pre-specified published in Lancet paper
- Post-hoc IVH and hydrocephalus
- Crossovers
- Meta-analysis
40Meta-analysis of 12 trials of surgery for ICH
(Mortality only)
41Meta-analysis of 12 trials of surgery for ICH
(Death or disability)
42Conclusions
- While there is no evidence to support a policy of
Early Surgery compared with a policy of
Initial Conservative Treatment in patients with
spontaneous supratentorial intracerebral
haemorrhage (Timing), pre-specified subgroup
analysis has suggested that Superficial
haematomas treated with craniotomy do better with
Early Surgery. - Meta-analysis suggests
- Superficial clots consider craniotomy
- Deep clots consider aspiration
- New Meta-analysis to evaluate lobar vs. deep with
no IVH (12 trials) - Patients with IVH and/or hydrocephalus have much
poorer outcomes and should be considered
separately (new trials)
43Intraventricular haemorrhage (IVH), Hydrocephalus
(HCP), Early Surgery(ES), Initial Conservative
treatment (ICT) Total Number of patients in
that group
44Lobar haemorrhages with No IVH and No
Hydrocephalus (prognosis based outcome)
Early surgery Initial Conservative Treatment
Favourable outcome 53 (49) 42 (37) 95
Unfavourable outcome 56 70 126
109 112 221
P0.095
45Lobar haemorrhages with No IVH and No
Hydrocephalus (prognosis based outcome)
Early surgery Initial Conservative Treatment
Favourable outcome 53 (49) 42 (37) 95
Unfavourable outcome 56 70 126
109 112 221
P0.095
46Lobar haematomas with No IVH and No Hydrocephalus
(prognosis based outcome)
47STICH II
- Supratentorial LOBAR ICH with no IVH or
hydrocephalus - Randomisation within 48 hours of ictus
- Surgery within 12 hours of randomisation
- Outcome as in STICH I
- 600 patients needed
- Funding applied for from UK MRC
48How do we manage a patient with Supratentorial
ICH?
- Observation clinically or with ICP/CPP monitoring
and operate with deterioration - Craniotomy if there is deterioration from GCS
between 9 and 12 and if the clot is superficial - Aspiration if the clot is deep another large
trial is needed (data from meta-analysis of
aspiration methods)
49Acknowledgements
- UK Stroke Association
- UK Medical Research Council (MRC)
- NIH, Northern Brainwave Appeal and NNF
- Investigators, patients and relatives from 107
centres in 27 countries - MRC Steering Committee
- MRC Data Monitoring and Ethics Committee
- All Co-investigators and Fellows