Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial.

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.

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests JBe reports research grants from the Swiss National Science Foundation (SNSF), the Swiss Heart Foundation (SHF), and the German Research Council; co-principal investigator role in the TOSCAN trial and fees for advisory boards and lectures from B Braun, Stryker, and Penumbra; and filed patents (PCT/EP2014/056340; PCT/EP2019/087124). CF reports support from Inselspital Stiftung. DS reports a research grant from governmental educational funding (Finland), hospital research funds (Helsinki University Hospital), and an unrestricted educational grant (Boehringer Ingelheim), with all funds handled by hospital-based institution; partner of the consortium funding for the PROOF trial (EU), LVO check (EU), and an electric impedance tomography project (Jane ja Aatos Erkon Säätiö); consultancies and scientific advisory board for Orion, Herantis Pharma, Boehringer Ingelheim, Portola, Alexion, AstraZeneca, Bristol Myers Squibb, and Janssen; and Data Safety Monitoring Board member role in the ENDOLOW trial. WJZ'G reports support from SNSF, Bangerter Stiftung, Von Tobel Stiftung, Herzstiftung, Baasch Medicus Stiftung, Parkinson Schweiz, Swiss Foundation for Research in Muscle Diseases, and the Stanley Thomas Johnson Foundation. JG reports global principal investigator role in STAR and SWIFT DIRECT trials and a consultancy role for Johnson & Johnson/Cerenovus. FR reports research support from Friedhelm Frees Foundation, state Rhineland Palatine; principal investigator role in PERLA-C study (fees paid to institution); consultancies for Brainlab, Stryker, Cybersurgery, and Spineart (fees paid to FR); speaker fees from Spineart, Stryker, Brainlab, and Ulrich (fees paid to FR); and royalties from Spineart (fees paid to FR). MA reports a scientific advisory board role for and lecture fees from Bayer, Medtronic, Novartis, and Sanofi; a scientific advisory board role for Amgen, Boehringer Ingelheim, BMS, Daiichi Sankyo, Pfizer, and Novo Nordisk; and grants from SNSF and SHF. RA-SS reports research grants from the UK National Institute for Health and Care Research and Chief Scientist Office of the Scottish Government; a consultancy role with Recursion Pharmaceuticals, Bioxodes, and Novo Nordisk (NN9931-4553 and NN9931-4554 endpoint adjudication committee), all paid to the University of Edinburgh, outside the submitted work. AHa reports a grant from SHF. NM-M reports a research grant from the Finnish Medical Foundation. PV reports grants or research support from Deutsche Forschungsgemeinschaft, EU, Einstein Stiftung, EANS, AOSpine, and Berliner Krebs Gesellschaft; honoraria from AOSpine, Brainlab, Spineart, Ulrich Medical, Zeiss, and Icotec; consultancy role with BIT Pharma, Sonovum, and Robeauté; and speaker or teacher fees from DWG, AOSpine, Eurospine, Brain Lab, Aesculap, Medtronic, Zeiss, Icotec, and ESO. RR reports a consultancy role with Ulrich Medical and a research grant from Else-Kröner-Fresenius-Stiftung. HBH received personal honoraria or unrestricted research grants from Portola Pharmaceuticals, Boehringer Ingelheim, Daiichi Sanyko, Bayer AG, Novartis, AstraZeneca, and CSL Behring, outside the submitted work. BK reports a scientific advisory board role with and lecture fees from AstraZeneca and Medtronic, outside the submitted work. RL and JL are senior clinical investigators of FWO Flanders. JC has received research support paid to his institution from Boehringer Ingelheim, Bayer, and AstraZeneca, and is a co-founder and shareholder of TrianecT. MM reports personal fees from Boehringer Ingelheim, AstraZeneca, Novo Nordisk, and Novartis. HPM reports personal fees from Medtronic, Stryker, and Cerenovus. AR reports research grants from Zeiss Meditech and a shareholder role for LEM surgical. UF reports 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 (BEYOND SWIFT, SWIFT DIRECT), 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. All other authors report no competing interests.