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Randomized Controlled Trial
Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial.
- Amrou Sarraj, Michael G Abraham, Ameer E Hassan, Spiros Blackburn, Scott E Kasner, Santiago Ortega-Gutierrez, Muhammad Shazam Hussain, Michael Chen, Hannah Johns, Leonid Churilov, Deep K Pujara, Faris Shaker, Laith Maali, Cardona PortelaPerePDepartment of Neurology, Hospital Universitari de Bellvitge, Bellvitge, Spain., Nabeel A Herial, Daniel Gibson, Osman Kozak, Juan F Arenillas, Bernard Yan, Natalia Pérez de la Ossa, Sophia Sundararajan, Yin C Hu, Dennis J Cordato, Nathan W Manning, Ricardo A Hanel, Amin N Aghaebrahim, Ronald F Budzik, William J Hicks, Jordi Blasco, Teddy Y Wu, Jenny P Tsai, Joanna D Schaafsma, Chirag D Gandhi, Fawaz Al-Mufti, Navdeep Sangha, Steven Warach, Timothy J Kleinig, Vignan Yogendrakumar, Felix Ng, Edgar A Samaniego, Mohammad A Abdulrazzak, Mark W Parsons, Mohammad H Rahbar, Thanh N Nguyen, Johanna T Fifi, Mendes PereiraVitorVDepartment of Neurology, St Michael's Hospital, Toronto, ON, Canada., Maarten G Lansberg, Greg W Albers, Anthony J Furlan, Pascal Jabbour, Clark W Sitton, Cathy Sila, Nicholas Bambakidis, Stephen M Davis, Lawrence Wechsler, Michael D Hill, James C Grotta, Marc Ribo, CampbellBruce C VBCVDepartment of Medicine and Neurology, University of Melbourne, Parkville, VC, Australia; Department of Internal Medicine and Neurology, Melbourne Brain Center-The Royal Melbourne Hospital, Parkville, VC, Australia; Department of Medici, and SELECT2 Investigators.
- Department of Neurology, University Hospital Cleveland Medical Center, Cleveland, OH, USA; Department of Neurology, Case Western Reserve University, Cleveland, OH, USA. Electronic address: amrou.sarraj@uhhospitals.org.
- Lancet. 2024 Feb 24; 403 (10428): 731740731-740.
BackgroundMultiple randomised trials have shown efficacy and safety of endovascular thrombectomy in patients with large ischaemic stroke. The aim of this study was to evaluate long-term (ie, at 1 year) evidence of benefit of thrombectomy for these patients.MethodsSELECT2 was a phase 3, open-label, international, randomised controlled trial with blinded endpoint assessment, conducted at 31 hospitals in the USA, Canada, Spain, Switzerland, Australia, and New Zealand. Patients aged 18-85 years with ischaemic stroke due to proximal occlusion of the internal carotid artery or of the first segment of the middle cerebral artery, showing large ischaemic core on non-contrast CT (Alberta Stroke Program Early Computed Tomographic Score of 3-5 [range 0-10, with lower values indicating larger infarctions]) or measuring 50 mL or more on CT perfusion and MRI, were randomly assigned, within 24 h of ischaemic stroke onset, to thrombectomy plus medical care or to medical care alone. The primary outcome for this analysis was the ordinal modified Rankin Scale (range 0-6, with higher scores indicating greater disability) at 1-year follow-up in an intention-to-treat population. The trial is registered at ClinicalTrials.gov (NCT03876457) and is completed.FindingsThe trial was terminated early for efficacy at the 90-day follow-up after 352 patients had been randomly assigned (178 to thrombectomy and 174 to medical care only) between Oct 11, 2019, and Sept 9, 2022. Thrombectomy significantly improved the 1-year modified Rankin Scale score distribution versus medical care alone (Wilcoxon-Mann-Whitney probability of superiority 0·59 [95% CI 0·53-0·64]; p=0·0019; generalised odds ratio 1·43 [95% CI 1·14-1·78]). At the 1-year follow-up, 77 (45%) of 170 patients receiving thrombectomy had died, compared with 83 (52%) of 159 patients receiving medical care only (1-year mortality relative risk 0·89 [95% CI 0·71-1·11]).InterpretationIn patients with ischaemic stroke due to a proximal occlusion and large core, thrombectomy plus medical care provided a significant functional outcome benefit compared with medical care alone at 1-year follow-up.FundingStryker Neurovascular.Copyright © 2024 Elsevier Ltd. All rights reserved.
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