TY - JOUR
T1 - Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage
T2 - a randomised controlled clinical trial
AU - SWITCH study investigators
AU - Beck, Jürgen
AU - Fung, Christian
AU - Strbian, Daniel
AU - Bütikofer, Lukas
AU - Z'Graggen, Werner J.
AU - Lang, Matthias F.
AU - Beyeler, Seraina
AU - Gralla, Jan
AU - Ringel, Florian
AU - Schaller, Karl
AU - Plesnila, Nikolaus
AU - Arnold, Marcel
AU - Hacke, Werner
AU - Jüni, Peter
AU - Mendelow, Alexander David
AU - Stapf, Christian
AU - Al-Shahi Salman, Rustam
AU - Bressan, Jenny
AU - Lerch, Stefanie
AU - Hakim, Arsany
AU - Martinez-Majander, Nicolas
AU - Piippo-Karjalainen, Anna
AU - Vajkoczy, Peter
AU - Wolf, Stefan
AU - Schubert, Gerrit A.
AU - Höllig, Anke
AU - Veldeman, Michael
AU - Roelz, Roland
AU - Gruber, Andreas
AU - Rauch, Philip
AU - Mielke, Dorothee
AU - Rohde, Veit
AU - Kerz, Thomas
AU - Uhl, Eberhard
AU - Thanasi, Enea
AU - Huttner, Hagen B.
AU - Kallmünzer, Bernd
AU - Jaap Kappelle, L.
AU - Deinsberger, Wolfgang
AU - Roth, Christian
AU - Lemmens, Robin
AU - Leppert, Jan
AU - Sanmillan, Jose L.
AU - Coutinho, Jonathan M.
AU - Hackenberg, Katharina A.M.
AU - Reimann, Gernot
AU - Mazighi, Mikael
AU - Bassetti, Claudio L.A.
AU - Mattle, Heinrich P.
AU - Wostrack, Maria
N1 - Publisher Copyright:
© 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
PY - 2024/6/1
Y1 - 2024/6/1
N2 - Background: It is unknown whether decompressive craniectomy improves clinical outcome for people with spontaneous severe deep intracerebral haemorrhage. The SWITCH trial aimed to assess whether decompressive craniectomy plus best medical treatment in these patients improves outcome at 6 months compared to best medical treatment alone. Methods: In this multicentre, randomised, open-label, assessor-blinded trial conducted in 42 stroke centres in Austria, Belgium, Finland, France, Germany, the Netherlands, Spain, Sweden, and Switzerland, adults (18–75 years) with a severe intracerebral haemorrhage involving the basal ganglia or thalamus were randomly assigned to receive either decompressive craniectomy plus best medical treatment or best medical treatment alone. The primary outcome was a score of 5–6 on the modified Rankin Scale (mRS) at 180 days, analysed in the intention-to-treat population. This trial is registered with ClincalTrials.gov, NCT02258919, and is completed. Findings: SWITCH had to be stopped early due to lack of funding. Between Oct 6, 2014, and April 4, 2023, 201 individuals were randomly assigned and 197 gave delayed informed consent (96 decompressive craniectomy plus best medical treatment, 101 best medical treatment). 63 (32%) were women and 134 (68%) men, the median age was 61 years (IQR 51–68), and the median haematoma volume 57 mL (IQR 44–74). 42 (44%) of 95 participants assigned to decompressive craniectomy plus best medical treatment and 55 (58%) assigned to best medical treatment alone had an mRS of 5–6 at 180 days (adjusted risk ratio [aRR] 0·77, 95% CI 0·59 to 1·01, adjusted risk difference [aRD] −13%, 95% CI −26 to 0, p=0·057). In the per-protocol analysis, 36 (47%) of 77 participants in the decompressive craniectomy plus best medical treatment group and 44 (60%) of 73 in the best medical treatment alone group had an mRS of 5–6 (aRR 0·76, 95% CI 0·58 to 1·00, aRD −15%, 95% CI −28 to 0). Severe adverse events occurred in 42 (41%) of 103 participants receiving decompressive craniectomy plus best medical treatment and 41 (44%) of 94 receiving best medical treatment. Interpretation: SWITCH 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. The results do not apply to intracerebral haemorrhage in other locations, and survival is associated with severe disability in both groups. Funding: Swiss National Science Foundation, Swiss Heart Foundation, Inselspital Stiftung, and Boehringer Ingelheim.
AB - Background: It is unknown whether decompressive craniectomy improves clinical outcome for people with spontaneous severe deep intracerebral haemorrhage. The SWITCH trial aimed to assess whether decompressive craniectomy plus best medical treatment in these patients improves outcome at 6 months compared to best medical treatment alone. Methods: In this multicentre, randomised, open-label, assessor-blinded trial conducted in 42 stroke centres in Austria, Belgium, Finland, France, Germany, the Netherlands, Spain, Sweden, and Switzerland, adults (18–75 years) with a severe intracerebral haemorrhage involving the basal ganglia or thalamus were randomly assigned to receive either decompressive craniectomy plus best medical treatment or best medical treatment alone. The primary outcome was a score of 5–6 on the modified Rankin Scale (mRS) at 180 days, analysed in the intention-to-treat population. This trial is registered with ClincalTrials.gov, NCT02258919, and is completed. Findings: SWITCH had to be stopped early due to lack of funding. Between Oct 6, 2014, and April 4, 2023, 201 individuals were randomly assigned and 197 gave delayed informed consent (96 decompressive craniectomy plus best medical treatment, 101 best medical treatment). 63 (32%) were women and 134 (68%) men, the median age was 61 years (IQR 51–68), and the median haematoma volume 57 mL (IQR 44–74). 42 (44%) of 95 participants assigned to decompressive craniectomy plus best medical treatment and 55 (58%) assigned to best medical treatment alone had an mRS of 5–6 at 180 days (adjusted risk ratio [aRR] 0·77, 95% CI 0·59 to 1·01, adjusted risk difference [aRD] −13%, 95% CI −26 to 0, p=0·057). In the per-protocol analysis, 36 (47%) of 77 participants in the decompressive craniectomy plus best medical treatment group and 44 (60%) of 73 in the best medical treatment alone group had an mRS of 5–6 (aRR 0·76, 95% CI 0·58 to 1·00, aRD −15%, 95% CI −28 to 0). Severe adverse events occurred in 42 (41%) of 103 participants receiving decompressive craniectomy plus best medical treatment and 41 (44%) of 94 receiving best medical treatment. Interpretation: SWITCH 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. The results do not apply to intracerebral haemorrhage in other locations, and survival is associated with severe disability in both groups. Funding: Swiss National Science Foundation, Swiss Heart Foundation, Inselspital Stiftung, and Boehringer Ingelheim.
UR - http://www.scopus.com/inward/record.url?scp=85194383905&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(24)00702-5
DO - 10.1016/S0140-6736(24)00702-5
M3 - Article
C2 - 38761811
AN - SCOPUS:85194383905
SN - 0140-6736
VL - 403
SP - 2395
EP - 2404
JO - The Lancet
JF - The Lancet
IS - 10442
ER -