STICH II: Early Surgery for Lobar Intracerebral Hemorrhage (2013) - ESBICM® | Educational Society of Bedside Intensive Care Medicine

STICH II: Early Surgery for Lobar Intracerebral Hemorrhage (2013)

“The STICH II results confirm that early surgery does not increase the rate of death or disability at 6 months and might have a small but clinically relevant survival advantage for patients with spontaneous superficial intracerebral haemorrhage without intraventricular haemorrhage.”

— The STICH II Investigators

1. Publication Details

Trial Title: Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial.
Citation: Mendelow AD, Gregson BA, Rowan EN, et al; for the STICH II Investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. Lancet. 2013;382(9890):397-408. doi:10.1016/S0140-6736(13)60986-1.
Published: August 3, 2013, in The Lancet.
Author: A. David Mendelow, D.Sc., F.R.C.S.
Funding: UK Medical Research Council and The Stroke Association.

2. Keywords

Intracerebral Hemorrhage (ICH), Stroke, Neurosurgery, Craniotomy, Lobar Hemorrhage, Neurocritical Care.

3. The Clinical Question

In conscious patients with spontaneous, superficial lobar intracerebral hemorrhage (Population), does a policy of early surgical hematoma evacuation (Intervention) compared to a policy of initial conservative treatment (Comparison) improve functional outcome at 6 months (Outcome)?

4. Background and Rationale

Existing Knowledge: The role of surgery for spontaneous intracerebral hemorrhage (ICH) was highly controversial. The first large trial, STICH, showed no overall benefit for early surgery but had a pre-planned subgroup analysis suggesting a potential benefit for patients with superficial (lobar) hemorrhages without intraventricular extension.
Knowledge Gap: It was unknown if this specific subgroup of patients—those who were conscious and had a superficial lobar hematoma—would truly benefit from early surgical evacuation. A dedicated trial was needed to test this hypothesis.
Proposed Hypothesis: The authors hypothesized that for patients with spontaneous superficial lobar ICH, a policy of early surgery would lead to a better functional outcome at 6 months compared to a policy of initial conservative treatment.

5. Study Design and Methods

Design: A prospective, multicenter, international, randomized, parallel-group, pragmatic trial.
Setting: 78 centers in 27 countries.
Trial Period: Enrollment from November 2006 to August 2012.
Population:
- Inclusion Criteria: Adult patients with a spontaneous lobar ICH (≤1 cm from the cortical surface) with a volume of 10-100 mL, within 48 hours of ictus, and a best motor score on the GCS of 5 or 6 and a best eye score of 2 or more (i.e., conscious).
- Exclusion Criteria: Intraventricular hemorrhage, hemorrhage from a known aneurysm or AVM, or severe pre-existing disability.
Intervention: Early surgical hematoma evacuation (usually by craniotomy) within 12 hours of randomization, plus best medical treatment.
Control: Initial conservative treatment (best medical treatment), with surgery reserved for neurological deterioration.
Management Common to Both Groups: All patients received best medical treatment according to local guidelines.
Power and Sample Size: The trial was powered to detect an absolute difference of 12% in favorable outcomes, requiring 600 patients.
Outcomes:
- Primary Outcome: A prognosis-based dichotomized outcome (favorable vs. unfavorable) based on the Extended Glasgow Outcome Scale (GOSE) at 6 months.
- Secondary Outcomes: Included 6-month mortality and distribution of GOSE scores.

6. Key Results

Enrollment and Baseline: 601 patients were randomized (307 to early surgery, 294 to initial conservative treatment). The groups were well-matched at baseline.
Trial Status: The trial was completed as planned.
Primary Outcome: There was no significant difference in the rate of unfavorable outcome at 6 months between the early surgery and initial conservative treatment groups (59% vs 62%; P=0.37).
Secondary Outcomes: There was a trend toward lower mortality at 6 months in the early surgery group, but this was not statistically significant (18% vs 24%; P=0.10).
Adverse Events: The rates of adverse events were similar between the two groups.

7. Medical Statistics

Analysis Principle: An intention-to-treat analysis was performed.
Statistical Tests Used: The primary outcome was analyzed using logistic regression.
Primary Outcome Analysis: The proportion of patients with a favorable or unfavorable outcome (based on a prognostic model) was compared between the two groups.
Key Statistic(s) Reported: Odds Ratio (OR) for unfavorable outcome with early surgery: 0.86 (95% CI, 0.62 to 1.20; P=0.37).
Interpretation of Key Statistic(s):
- Odds Ratio (OR): An OR of 0.86 suggests a 14% lower odds of an unfavorable outcome with surgery, but this was not statistically significant.
- Confidence Interval (CI): The 95% CI widely crosses 1.0, indicating no statistically significant difference.
- P-value: The p-value of 0.37 confirms the lack of a statistically significant difference.
Clinical Impact Measures: Not applicable as no benefit was shown for the primary outcome.
Subgroup Analyses: A post-hoc analysis suggested that patients with a poorer prognosis at baseline (GCS 9-12) appeared to have a greater benefit from early surgery.

8. Strengths of the Study

Study Design and Conduct: This was a large, international, multicenter randomized trial that addressed a very specific and important clinical question generated by its predecessor trial.
Generalizability: The inclusion of 78 centers worldwide increases the external validity of the findings.
Focused Population: The trial successfully recruited the specific subgroup of patients it was designed to study.

9. Limitations and Weaknesses

Internal Validity (Bias): The study was unblinded. A significant number of patients (21%) in the conservative treatment group crossed over to receive surgery, which would tend to bias the result toward the null.
External Validity (Generalizability): The results are only applicable to the highly selected population of conscious patients with superficial lobar ICH.
Other: The primary outcome was neutral. The observed benefit was smaller than the trial was powered to detect.

10. Conclusion of the Authors

11. To Summarize

Impact on Current Practice: The STICH II trial, like its predecessor, had a neutral primary outcome. It did not provide the definitive evidence needed to recommend routine early surgery for all patients with superficial lobar ICH. However, by showing that surgery was not harmful and suggesting a potential survival benefit in patients with a poorer prognosis, it provides support for considering surgery on an individual basis, especially for patients who are deteriorating.
Specific Recommendations:
- Patient Selection: For conscious adult patients with a spontaneous, superficial lobar ICH of 10-100 mL.
- Actionable Intervention: A policy of early surgery is not routinely superior to initial conservative management. However, it can be considered a safe option, particularly for patients with a poorer prognosis (e.g., lower GCS) at presentation.
- Expected Benefit: No proven improvement in functional outcome, but a possible small survival advantage.
What This Trial Does NOT Mean: This trial does not mean that surgery is futile for ICH. It helps define a population where initial conservative management is a very reasonable approach, with surgery reserved for clinical worsening.
Implementation Caveats: The decision to operate remains a complex one, balancing the patient’s clinical state, hematoma characteristics, and the risks of surgery.

12. Context and Related Studies

Building on Previous Evidence: This trial was a direct result of the subgroup findings from the original STICH trial (2005). It was designed to provide a definitive answer for this specific patient group.
Influence on Subsequent Research: The neutral results of both STICH and STICH II for conventional craniotomy have spurred significant interest in minimally invasive surgery (MIS) techniques for hematoma evacuation. Trials like MISTIE III (2019) and ENRICH (2023) have since evaluated these less invasive approaches.

13. Unresolved Questions & Future Directions

Unresolved Questions: What is the optimal timing of surgery for patients in the conservative arm who deteriorate? Could minimally invasive techniques provide the benefit that conventional craniotomy did not?
Future Directions: The focus of surgical ICH research has largely shifted from whether to operate to how to operate, with an emphasis on minimally invasive techniques that aim to maximize clot evacuation while minimizing iatrogenic injury.

14. External Links

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

15. Framework for Critical Appraisal

Clinical Question: The question was highly relevant, testing a specific, plausible hypothesis generated from the largest previous trial on the topic.
Methods: The multicenter RCT design was appropriate and well-conducted. The pragmatic nature and international scope are strengths.
Results: The trial had a clear neutral result for its primary functional outcome. The trend toward a survival benefit is hypothesis-generating but not definitive. The high crossover rate in the conservative arm complicates interpretation.
Conclusions and Applicability: The authors’ conclusion is a fair and balanced interpretation of the data. The trial is highly applicable to neurosurgeons and intensivists, providing evidence to support initial conservative management in many conscious patients with lobar ICH, while also identifying a subgroup with poorer prognosis who may still be considered for early surgery.

16. Disclaimer and Contact

This summary is provided by the Academic Committee of ESBICM (ACE) to facilitate the understanding of this study; readers are advised to refer to the original trial document for a deeper understanding. If you find any information incorrect, or missing, or it needs an update or have a request for a specific critical care trial summary, kindly write to us at academics[at]esbicm.org.