SWITCH
(2024)Objective
Assess whether decompressive craniectomy plus best medical treatment improves functional outcome at 6 months compared with best medical treatment alone in patients with severe deep supratentorial intracerebral hemorrhage.
Study Summary
Intervention
Multicenter, randomized, open-label, assessor-blinded trial in 42 centers across Europe. Patients aged 18–75 years with ICH involving basal ganglia or thalamus were randomized to decompressive craniectomy (≥12 cm diameter, without hematoma evacuation) plus best medical treatment vs. best medical treatment alone. N=197; median hematoma volume ~57 mL; follow-up at 180 and 365 days.
Study Design
Arms: Array
Outcome
• Mortality at 180 days: 17% vs. 27%; aRR 0.61 (95% CI 0.36–1.01)
• mRS shift analysis at 180 days: common OR 0.57 (95% CI 0.34–0.97)
• Serious adverse events: 42% (surgery) vs. 44% (control), no significant difference
• Length of hospital stay: median 19.5 days (surgery) vs. 23.5 days (control), p=0.018
Bottom Line
The SWITCH trial provides weak evidence that decompressive craniectomy plus best medical treatment might be superior to best medical treatment alone in people with severe deep intracerebral haemorrhage, with a trend toward improved outcome but survival remained associated with severe disability in both groups.
Major Points
- The trial was stopped early due to lack of funding, resulting in being underpowered for the primary endpoint.
- In the intention-to-treat analysis, 42 (44%) of 95 participants in the decompressive craniectomy group and 55 (58%) of 95 in the best medical treatment group had an mRS of 5–6 at 180 days (adjusted risk ratio [aRR] 0.77, 95% CI 0.59 to 1.01, p=0.057).
- Ordinal mRS analysis favored surgery (common odds ratio 0.57, 95% CI 0.34 to 0.97).
- Mortality at 180 days was lower with surgery: 17% vs 27%.
- Severe adverse events occurred in 41% (surgery) vs 44% (control).
- Median hospital stay was shorter in the surgical group: 19.5 vs 23.5 days (p=0.018).
- Survival remained associated with severe disability in most cases.
Study Design
- Study Type
- Multicentre, randomised, open-label, assessor-blinded trial
- Randomization
- Yes
- Blinding
- Assessor-blinded for outcome assessment; investigators and core lab staff masked to allocation and outcomes.
- Sample Size
- 201
- Follow-up
- 6 months (primary outcome), up to 12 months total
- Centers
- 42
- Countries
- Austria, Belgium, Finland, France, Germany, Netherlands, Spain, Sweden, Switzerland
Primary Outcome
Definition: mRS 5–6 at 180 days in the intention-to-treat population
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 58% | 44% | 0.77 (0.59 to 1.01) | 0.057 |
Limitations & Criticisms
- Underpowered due to early termination after only 201 of planned 300 patients enrolled.
- Assumed large treatment effect may have masked smaller benefits.
- Open-label design, with possible bias from participant awareness.
- Variability in surgical technique and evolving care standards over long enrollment period.
- Limited female representation (~33%) and lack of ethnic data.
- Data from imaging core lab on specific anatomical involvement not provided.
Citation
Lancet 2024; 403: 2395-404