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SWITCH Trial

Dr Swapnil Pawar June 13, 2024 218


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    SWITCH Trial
    Dr Swapnil Pawar

 

Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral hemorrhage: a randomized controlled clinical trial

Beck J, Fung C, Strbian D, et al. Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial. Lancet. Published online May 14, 2024

Blog written by Dr Jose Chacko 

Clinical question

 

Does decompressive craniectomy combined with best medical care improve clinical outcomes in spontaneous intracerebral hemorrhage compared with best medical care alone?

 

Population and design

 

The SWITCH randomized controlled trial (RCT) was conducted between October 2014 and April 2023 across 42 stroke centers in nine countries in Europe. The study evaluated the efficacy of decompressive craniectomy in spontaneous, deep, supratentorial intracerebral hemorrhage. Patients were randomized in a 1:1 ratio to undergo decompressive craniectomy combined with best medical treatment, or best medical treatment alone.

 

Inclusion criteria

 

The study included adults with severe, deep intracerebral hemorrhage, involving the basal ganglia and thalamus with possible extension into the cerebral hemispheres, ventricles, or subarachnoid space. Diagnosis was based on CT or MR imaging. The study patients had a GCS of 8–13, NIHSS score of 10–30, and a hematoma volume of 30–100 ml. Randomization was within 66 hours of onset of symptoms. An INR of <1.5 and platelet count >100,000/ cu mm were required for eligibility. Decompressive craniectomy had to be performed within 6 hours of randomization.

 

Excluded

 

  • ICH due to known or suspected structural abnormality
  • Hemorrhage involving cerebellum or brainstem
  • Hemorrhage confined to the cerebral hemispheres without involvement of basal ganglia or thalamus
  • Known advanced dementia, known neurological disability (mRS score of ≥2)
  • Patients expected to die within 24 hours
  • ICH secondary to thrombolysis
  • Bilateral non-reactive pupils

 

Decompressive craniectomy group

Besides best medical treatment, decompressive craniectomy was performed with a skull flap of ≥12 cm. The hematoma was not evacuated. Cranioplasty was carried out within 1–5 months of the procedure.

Control group

In the control group, patients received best medical treatment alone.

Sample size

The sample size was based on a score of 5–6 on the mRS at 180 days, the primary outcome (see below).

 

The modified Rankin Score (mRS) 

Points Disability grade
0 No symptoms
1 Some symptoms, but able to perform all usual activities
2 Slight disability; able to carry out daily activity without assistance. Unable to perform all previous activities
3 Moderate disability; needs help. Able to walk without assistance
4 Moderately severe disability. Unable to walk without assistance; needs assistance for own bodily needs
5 Severe disability; unable to attend to bodily needs without constant assistance. Incontinent
6 Dead

 

 

The investigators assumed a risk of 0.53 for a mRS of 5 or 6 in the control group. A sample size of 300 patients provided the study with >85% power to detect a relative risk reduction of 33% at a two-sided alpha level of 0.05.

 

Results

 

The study was ceased after enrolment of 201 patients due to lack of funding. Ninety-five patients in each arm were included in the final analysis. Eight patients crossed over from the best medical treatment to the decompressive craniectomy group; one patient who was randomized to undergo decompressive craniectomy received best medical treatment alone. Nine patients in the decompressive craniectomy group and eight in the best medical treatment group underwent hematoma evacuation which was not part of the study protocol.

 

Patients were well-matched at baseline – the median GCS was 10 (IQR: 9–12) in both groups. The median NIHSS score was 18 in the DC group and 19 in the best medical treatment group. Intraventricular extension was present in 28% and 30% respectively. The median hematoma volume was 57 ml (IQR 44–74). The median time from onset of symptoms to surgery was 26 hours; the median diameter of the skull flap was 13 cm.

 

Outcomes

 

The primary outcome: mRS at 180 days

 

At 180 days, there were more patients with an unfavorable neurological outcome, with mRS was 5–6 among patients who underwent best medical treatment alone. The mRS was between 5–6 in 42/95 (44%) patients in the DC arm compared with 55/95 (58%) in the best medical treatment group. The adjusted risk ratio (aRR), in favor of DC was 0·77, [(95% CI 0·59 to 1·01), P = 0·057].  The results were similar on per-protocol analysis – the mRS was 5–6 in 36/77 (47%) in the decompressive craniectomy group and 44/73 (60%) in the best medical treatment group (aRR 0·76, 95% CI 0·58 to 1·00).

 

Secondary outcomes

 

There was a trend towards improved survival at 180 days among patients in the DC group (17% vs. 27%; P = 0·065). There was no significant difference in mRS 4–6 or mortality between groups at 180 and 365 days. The median duration of hospital stay was significantly shorter in the DC group (19·5 vs. 23.5 days, P = 0.018).

 

Improved survival came at a risk of attaining an mRS of 4 – an outcome that may not be preferable; mRS of 0–3 was similar in both groups. The hematoma volume at 48 hours and extent of post-hemorrhagic brain defects at 180 days were similar in both groups.

 

There was no difference between groups in the quality of life after 6 months, assessed using the EuroQol visual analog scale. The proportion of patients who needed permanent residential care was similar at 6 months and 1 year.

 

At study completion, 77% of patients who underwent DC reported that they would have undergone surgery again.

 

The incidence of adverse events were also similar in both groups (DC: 41% vs. best medical treatment: 44%).

 

Conclusions

 

The SWITCH study offered weak evidence that decompressive craniectomy combined with best medical treatment might be superior to best medical treatment alone. However, survival is associated with severe disability in both groups.

 

Strengths

 

The SWITCH trial was the first RCT that evaluated the outcomes from decompressive craniectomy in spontaneous intracerebral hemorrhage. The trial design was appropriate for the intervention studied. Randomization was central, with allocation concealment and the outcome was evaluated by independent assessors. Follow-up was nearly complete (96%). An absolute risk reduction of 13% and a relative risk reduction of 23% for mRS 5–6 was observed with DC. Although ceased before attaining sample size, it was larger than studies that evaluated DC in stroke patients (DECIMAL, DESTINY, and HAMLET).

 

Limitations

 

  • The trial was ceased before attaining the planned sample size, leading to an underpowered study.

 

  • Improved survival came at a risk of attaining an mRS of 4 (unable to walk without assistance; needs assistance for own bodily needs) – an outcome that may not be preferable. Patients with mRS of 0–3 was similar in both groups

 

  • The assumed relative risk reduction of 33% used to calculate the sample size may have been too large.

 

  • Uneven randomization across centers

 

  • The standard of care changed during the course of the study (9.5 years), with some centers introducing minimally invasive surgery.

 

  • Crossover occurred between groups

 

  • Hematoma evacuation (not included in the protocol) was carried out in a few patients.

 

  • Primary outcome was conducted by telephonic interview. Although assessors were unaware of the treatment allocation, group assignment may have become evident during the conversation (inadvertently revealed by the participant).

 

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