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Clinical Trial
. 2024 Feb 24;403(10428):731-740.
doi: 10.1016/S0140-6736(24)00050-3. Epub 2024 Feb 9.

Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial

Amrou Sarraj  1 , Michael G Abraham  2 , Ameer E Hassan  3 , Spiros Blackburn  4 , Scott E Kasner  5 , Santiago Ortega-Gutierrez  6 , Muhammad Shazam Hussain  7 , Michael Chen  8 , Hannah Johns  9 , Leonid Churilov  9 , Deep K Pujara  10 , Faris Shaker  4 , Laith Maali  2 , Pere Cardona Portela  11 , Nabeel A Herial  12 , Daniel Gibson  13 , Osman Kozak  14 , Juan F Arenillas  15 , Bernard Yan  16 , Natalia Pérez de la Ossa  17 , Sophia Sundararajan  10 , Yin C Hu  18 , Dennis J Cordato  19 , Nathan W Manning  20 , Ricardo A Hanel  21 , Amin N Aghaebrahim  21 , Ronald F Budzik  22 , William J Hicks  23 , Jordi Blasco  24 , Teddy Y Wu  25 , Jenny P Tsai  7 , Joanna D Schaafsma  26 , Chirag D Gandhi  27 , Fawaz Al-Mufti  27 , Navdeep Sangha  28 , Steven Warach  29 , Timothy J Kleinig  30 , Vignan Yogendrakumar  31 , Felix Ng  31 , Edgar A Samaniego  6 , Mohammad A Abdulrazzak  7 , Mark W Parsons  19 , Mohammad H Rahbar  32 , Thanh N Nguyen  33 , Johanna T Fifi  34 , Vitor Mendes Pereira  35 , Maarten G Lansberg  36 , Greg W Albers  36 , Anthony J Furlan  10 , Pascal Jabbour  12 , Clark W Sitton  37 , Cathy Sila  10 , Nicholas Bambakidis  18 , Stephen M Davis  31 , Lawrence Wechsler  38 , Michael D Hill  39 , James C Grotta  40 , Marc Ribo  41 , Bruce C V Campbell  42 ; SELECT2 Investigators
Affiliations
Clinical Trial

Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial

Amrou Sarraj et al. Lancet. .

Abstract

Background: Multiple 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.

Methods: SELECT2 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.

Findings: The 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]).

Interpretation: In 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.

Funding: Stryker Neurovascular.

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Conflict of interest statement

Declaration of interests AS received grant support from Stryker Neurovascular for the SELECT2 trial. AEH is a data and safety monitoring board (DSMB) member for the COMAND trial; has received grants from Penumbra, Viz.ai, Perfuze and, Medtronic; and reported consulting fees from Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera Therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, Rapid Medical, Imperative Care, Galaxy Therapeutics, Route 92, and Perfuze. MSH reports consulting fees from Keneka and is a DSMB member for Stryker, Cerenovus, and Tiger Medical. SO-G is the Treasurer of the Society of Vascular and Interventional Neurology; has received grants from the National Institutes of Health's (NIH) National Institute of Neurological Disorders and Stroke funding, Stryker Neurovascular, Methink, and Microvention; and consulting fees and honoraria from Medtronic and Stryker Neurovascular. BY reports grants and consulting fees from Stryker and Medtronic. SEK is a DSMB member for AstraZeneca beyond 36 months; has received grants from Bayer, Medtronic, Diamedica, and Genentech; has received royalties from UpToDate; and consulting fees from Shionogi and AbbVIE. MC has received consulting fees from Medtronic and Penumbra beyond 36 months. CWS received salary support for his role within an imaging core laboratory in the SELECT, SELECT2, SEGA, and SIPA trials. DG reports grants from Styrker; has received consulting fees from Siemens Healthineers and iSchemaView; travel support from Penumbra; and has a leadership role in the stroke performances oversight committee. JFA reports grant support from the Spanish Ministry of Science, AstraZeneca, and Pfizer; consulting fees from Medtronics, Pfizer and BMS, and AstraZeneca; honoraria payment from Medtronics, AstraZeneca, Pfizer and BMS, Amgen, and Daichii-Sankyo; and DSMB membership for the RACECAT trial and WETRUST trial. RAH reports grants from NIH, Stryker, Microvention, Interline Endowment, and CNX; consulting fees from Medtronic, Balt USA, Stryker, QApel Medical, Codman Neuro, Cerenovus, Microventio, Imperative Care, Phenox, and Rapid Medical; is a DSMB member for MIVI, eLum, Three Rivers, Shape Medical, and Corindus; has a leadership role in JNIS; and stock options in InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical, Scientia, RisT, Blink TBI, and Corindus. NWM has received consulting fees from Microvention, Stryker, Medtronic, and Balt. RFB reports grants from Styrker to their institution. NPdlO is a DSMB member for CHOICE-2 and has a leadership role in ISC Scientific Committee and the Stroke: Vascular and Interventional Neurology Journal. FN reports grants from the National Heart Foundation (Australia), the National Health and Medical Research Council (Australia), and the Bethlehem Griffiths Research Foundation. JB is a member of the speakers' bureau for Stryker Neurovascular and Microvention and has leadership and advisory roles with Inspire S and A registries (Medtronics). SW received grants from the University of Texas, University Hospital Cleveland Medical Center, and State of Texas LoneStar Stroke Consortium; is the DSMB chair for the TIMELSS trial; reported consulting fees from Brainsgate; and has a leadership role in Austin Speech Lab. JPT reports consulting fees from Medtronic; honoraria payments from QApel Medica, Imperative Care, Cerenovus, and Microvention; and a leadership role in the Society of NeuroInterventional Surgery. NAH reports consulting and honoraria fees from Medtronic. TNN is a DSMB member for the SELECT2 and CREST-2 trials; is on the advisory board for Brainomix and Idorsia; and is the president elect for the Society of Vascular and Interventional Neurology. LW is the DSMB chair for the SELECT2 trial and has reported consulting fees from Silk Road Medical, Astellas Pharma, Forest Devices, and Ahteresys. JTF reports consulting fees from Stryker, Cerenovus, and Microvention; had a leadership role in the Society of NeuroInterventional Surgery; is a DSMB member for the SELECT and MIVI trials; and has stock options in Imperative Care. MDH is the president of the Canadian Neurological Sciences Federation; is a board member of the Canadian Stroke Consortium; is a DSMB member for the RACECAT trial, Oncovir Hiltonel trial, DUMAS trial, ARTESIA trial, and the BRAIN-AF trial; has received grants from a Boehringer Ingelheim grant to the University of Calgary for the TEMPO_2 trial, from Biogen to the University of Calgary, from NoNO, from the Canadian Institutes for Health Research for the ESCAPE-NA1 trial and the ESCAPE-NEXT trial, and from Medtronic to the University of Calgary for the HERMES collaboration; has received consulting fees from Sun Pharma and Brainsgate; has US Patent 62/086,077 and 10,916,346; and stocks in Circle and PureWeb. MR reports consulting fees from Medtronic, Anaconda Biomed, Cerenovus, and Nora Health; honoraria payments from Boehringer Ingelheim and Vesalio; and has stock options in Averto, Anaconda Biomed, and CVAid. GWA reports personal fees from Genentech, Janssen Global Services, Medtronic, IschemaView, AstraZeneca Pharmaceuticals, and Biogen, outside the submitted work and has a patent entitled Automated detection of arterial input function and/or venous output function voxels in medical imaging issued. All other authors declare no competing interests.

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