Operative intervention in ICH: Results of the International Surgical Trial in Intracerebral Haemorrhage (STICH)

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Operative 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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Question 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

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Time since ictus
Median 20 hrs

hrs
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Primary Outcome(Prognosis Based)
Early Surgery Initial Conservative treatment
Favourable 122 (26.1) 118 (23.8)
Unfavourable 346 (73.9) 378 (76.2)
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Primary Outcome Prognosis Based
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Mortality
Early Surgery Initial Conservative treatment
Alive 304 (63.7) 316 (62.6)
Dead 173 (36.3) 189 (37.4)
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Mortality
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Kaplan Meier Plot of Survival
Early Surgery
Initial Conservative Treatment
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Secondary OutcomeRankin (Prognosis Based)
Early Surgery Initial Conservative treatment
Favourable 152 (32.8) 137 (28.1)
Unfavourable 312 (67.2) 351 (71.9)
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Secondary OutcomeRankin (Prognosis Based)
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Secondary OutcomeBarthel (Prognosis Based)
Early Surgery Initial Conservative treatment
Favourable 124 (26.7) 110 (22.6)
Unfavourable 341 (73.3) 377 (77.4)
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Secondary OutcomeBarthel (Prognosis Based)
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Primary and Secondary Outcome

• The overall result is NEUTRAL
• NOT POSITIVE or NEGATIVE

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Primary 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

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Primary 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

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Favours surgery Favours control
Pre- specified subgroup analysis

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Favours surgery Favours control
GCS
Lobar
Depth
Craniotomy
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Conclusions

• 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.

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Primary 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

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Primary 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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Post-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)
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• 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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Intraventricular haemorrhage (IVH), Hydrocephalus
(HCP), Early Surgery(ES), Initial Conservative
treatment (ICT) Total Number of patients in
that group
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Intraventricular haemorrhage (IVH), Hydrocephalus
(HCP), Early Surgery(ES), Initial Conservative
treatment (ICT) Total Number of patients in
that group
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Lobar 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
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Lobar haematomas with No IVH and No Hydrocephalus
(prognosis based outcome)
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Primary 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

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Crossovers from intention to treat (ICT Initial
Conservative Treatment)
(M Prasad et al. Ann Arbour 2005)
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Crossovers and GCS in ICT group of 140
crossovers to surgery

• Average drop in GCS at crossover was 3 points

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Volume in ICT group of 140 crossovers to surgery
(in red)
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Depth from cortical surface in ICT group of 140
crossovers (in red)
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Factors 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

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Primary 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

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Meta-analysis of 12 trials of surgery for ICH
(Mortality only)
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Meta-analysis of 12 trials of surgery for ICH
(Death or disability)
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Conclusions

• 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)

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Intraventricular haemorrhage (IVH), Hydrocephalus
(HCP), Early Surgery(ES), Initial Conservative
treatment (ICT) Total Number of patients in
that group
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Lobar 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
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Lobar 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
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Lobar haematomas with No IVH and No Hydrocephalus
(prognosis based outcome)
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STICH 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

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How 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)

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Acknowledgements

• 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