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STICH2

STICH2. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial

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STICH2

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  1. STICH2

  2. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial A David Mendelow, Barbara A Gregson, Elise N Rowan, Gordon D Murray, Anil Gholkar, Patrick M Mitchell, for the STICH II Investigators www.thelancet.com Published online May 29, 2013 http://dx.doi.org/10.1016/S0140-6736(13)60986-1

  3. Background • Stroke – 3rd highest cause of death (heart disease and cancer 1 and 2) • Spont ICH – 8-14% strokes • Mortality up to 50% • Independence 20% at 6/12 • Large/ expanding Haematoma, hyperglycaemia, seizures and BP elevation related to outcome

  4. STICH 1 • Failed to show a benefit from early surgey (haematoma evacuation) v conservative Mx- (worse outcomes with surgery especially if large/ intraventricular haemorrhage) • Of the prespecified subgroups that were examined, patients with an ICH within 1cm of the cortical surface showed a benefit for early surgery • Statistical testing of this subgroup was not adjusted for the multiple subgroup comparisons

  5. STICH II • Performed to confirm a benefit of surgery in the latter group • 601 patients who had a spontaneous lobar ICH on computed tomography (1 cm or less from the cortical surface of the brain) • Volume 10 to 100 mL • <48 hours of ictus • Best motor score on the GCS of 5 or 6 • Best eye score of 2 or more. • Randomly assigned to early surgery or conservative treatment.

  6. Primary outcome was a prognosis-based favorable or unfavorable outcome as defined by the score on the Extended Glasgow Outcome Scale at 6 months. • This was calculated by answers to 14 questions sent by mail to patients or their relatives • Large crossover in the conservative group, with 21% of these patients ending up having surgery, mostly because of deterioration. • The authors noting that: "these are the ones with the worst prognosis when surgeons are compelled to operate."

  7. Table. STICH-II: 6-Month Results Primary analysis (intention to treat) showed a small but nonsignificant increase in the number of patients having a favorable outcome at 6 months in the early surgery group. “Suggestion” of a reduction in mortality – (nonsignificant)

  8. Conclusion.. • A benefit of 4% is not really enough to change practice • Deaths were significantly lower in the surgery group at 30 and 90 days but not at 6 months — the time of the primary endpoint. • Underpowered, even with the similar patients from STICH I it does not quite reach statistical significance • Does provide the best evidence available however still no evience of benefit • 2 trials using minimally invasive procedures — CLEAR III (Clot Lysis: Evaluating Accelerated Resolution of IntraventricularHemorrhage III) and MISTIE III (Minimally Invasive Surgery plus rt-PA for ICH Evacuation III) — are continuing

  9. What else..? • BP lowering ineffective – moderate loweringstillrecommended in AHA guidelines (level C evidence) • rF5VIIIa reduces haematoma expansion but did not impact outcomes • Tight glucose control – nil benefit from glucose infusions v sliding scales. One study showed significantly worse outcomes

  10. New Avenues or therapy: • Apoptosis of neurons within the haematoma and surrounding issue occurs with TNF receptor subtypes implicated as a critical component. Attempts to modulate this pathophysiological process has become one of the primary foci of research...

  11. Management • Excellent supportive care • Sensitive discussion with family • Referral to stroke unit • Anticoagulation reversal when applicable • FFP use to reverse warfarin (contains factors II, VII, IX and X required) - can require 10u (2000ml) to reverse INR - can be a problem in patients with background of cardiac disease .Time to reversal varies in studies: 7-32 hours due to practical considerations. • PCC (prothrombin complex concentrate) has rapid action (about 20 minutes) with minimum volume required - expensive, risk of thrombotic complications, DIC. • Vitamin K - has an effect as early as 4 hours and can reverse the INR as early as 8 hours. Risks - anaphylaxis (rare). • Factor VIIa also reverses the INR within minutes - risk of increased thrombotic complication. $$ expensive

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