Decompressive Craniectomy Beneficial in Severe, Deep ICH

Decompressive craniectomy appears to be beneficial in patients with severe deep intracerebral hemorrhage, new research suggested.

Although the results just missed statistical significance, possibly because the trial was stopped early due to funding issues, there was a substantial reduction in the primary outcome — the number of patients who died or had very severe disability at 6 months.

"SWITCH is the first study worldwide showing that a substantial reduction may be possible in mortality and disability of people with a severe deep intracerebral hemorrhage."

"Our results are even more important given that there is currently no other treatment option for these people," said senior investigator Urs Fischer, MD, University Hospital Basel, Basel, Switzerland.

The SWITCH trial was presented on May 15 at the European Stroke Organization Conference (ESOC) 2024.

The trial was also simultaneously published online in The Lancet.

An Unresolved Issue

Investigators noted that treatment of severe deep supratentorial intracerebral hemorrhage is a major unresolved issue in stroke management, with all pharmacological and surgical treatment approaches evaluated previously having failed to reduce morbidity and mortality.

A small retrospective series and a systematic review of observational studies evaluating decompressive craniectomy without clot evacuation have shown reduced mortality and an association with better outcomes than the best medical treatment alone.

However, decompressive craniectomy is a major surgical intervention carrying considerable risk for hemorrhagic, infectious, and cerebrospinal fluid disturbance-related complications.

The SWITCH trial, conducted in 42 stroke centers in Europe, Austria, Belgium, Finland, France, Germany, the Netherlands, Spain, Sweden, and Switzerland, randomly assigned adult patients with a severe intracerebral hemorrhage involving the basal ganglia or thalamus to receive either decompressive craniectomy plus best medical treatment or best medical treatment alone.

The primary outcome was severe disability or death as assessed by a score of 5 or 6 on the modified Rankin Scale (mRS) at 180 days.

The trial was conducted over 9 years and was stopped prematurely due to a lack of funding in 2023 after 201 of the planned 300 participants had been enrolled. Patients had a median age of 61 years and a median hematoma volume of 57 mL.

Results showed that the primary endpoint occurred in 44% of those assigned to decompressive craniectomy vs 58% of those receiving best medical treatment alone, giving an adjusted risk ratio (aRR) of 0.77 (95% CI, 0.59-1.01), and an adjusted absolute risk difference (aRD) of −13% (95% CI, −26 to 0; P = .057).

In the per-protocol analysis, 47% of 77 participants in the decompressive craniectomy group and 60% of 73 in the best medical treatment alone group had an mRS score of 5-6 (aRR, 0.76; 95% CI, 0.58-1.00 and aRD, −15%; 95% CI, −28 to 0).

Severe adverse events occurred in 41% of patients receiving decompressive craniectomy and 44% of those who were assigned to the best medical treatment alone.

Clinically Meaningful

While the results are not statistically significant, the investigators noted that the "point estimate of the treatment effect is clinically meaningful and is considerably higher than that of any other treatment intervention in people with intracerebral hemorrhage."

Noting that most other intracerebral hemorrhage trials have used an mRS score of 0-3 as a favorable outcome and an mRS score of 4-6 as an unfavorable outcome, they suggested that an mRS score of 0-4 is a more realistic favorable outcome for very severely affected patients fulfilling the SWITCH trial's eligibility criteria.

However, they pointed out: "SWITCH showed that the benefit of decompression did not come at the cost of an increased number of participants with an mRS of 5, and most survivors were switched into the mRS 4 group. However, there was no difference in the number of participants with mRS 0-3 between the two treatment groups."

"Ultimately, it remains a highly individual decision whether an mRS score of 4 can be considered as a better outcome than being dead," the researchers commented. But they reported that 77% of those who underwent surgery said they would do so again.

They added that the trial excluded people with a Glasgow Coma Scale score of 4-7 because the aim of the trial was to reduce disability and to avoid, if possible, an outcome of mRS score of 5, rather than to reduce mortality at any cost.

The authors emphasized that the results of the SWITCH trial apply to a subgroup of patients with severe deep intracerebral hemorrhage and cannot be generalized to those with intracerebral hemorrhage in other locations. They also acknowledged that, irrespective of treatment, survival was associated with severe disability in both treatment groups.

Results Not Generalizable

Commenting on the SWITCH study at the ESOC meeting, Robin Lemmens, UZ Leuven, Leuven, Belgium, said the results will help support a conversation with relatives.

"While these results may not change the guidelines, I think they will help us inform patients and relatives about this potential option, which decreases the risk of being in a very dependent state (mRS, 5), and this is something that can be considered. It is not always a matter of having overwhelming statistical significance to help us make decisions."

The SWITCH trial was supported by the Swiss National Science Foundation (SNSF), the Swiss Heart Foundation (SHF), the Inselspital-Stiftung, and a small, unrestricted grant from Boehringer Ingelheim.

Fischer reported research support from the SNSF and the SHF; a principal investigator role in the ELAN trial and a co-principal investigator role in the DISTAL, TECNO, SWIFT DIRECT, SWITCH, ELAPSE, and ICARUS trials; research grants from Medtronic, Stryker, Rapid Medical, Penumbra, Medtronic, and Phenox (DISTAL), and Boehringer Ingelheim (TECNO), paid to the institution; consultancies for Medtronic, Stryker, and CSL Behring (fees paid to institution); participation in an advisory board for Alexion/ Portola, Boehringer Ingelheim, Biogen, and Acthera (fees paid to institution); a membership role in a clinical event committee of the COATING study (Phenox) and on a data and safety monitoring committee of the TITAN, LATE_MT, and IN EXTREMIS trials; and presidency of the Swiss Neurological Society.

Lemmens reported institutional fees for consultancy from Genentech and iSchemaView.