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Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial.
Sarraj, Amrou; Abraham, Michael G; Hassan, Ameer E; Blackburn, Spiros; Kasner, Scott E; Ortega-Gutierrez, Santiago; Hussain, Muhammad Shazam; Chen, Michael; Johns, Hannah; Churilov, Leonid; Pujara, Deep K; Shaker, Faris; Maali, Laith; Cardona Portela, Pere; Herial, Nabeel A; Gibson, Daniel; Kozak, Osman; Arenillas, Juan F; Yan, Bernard; Pérez de la Ossa, Natalia; Sundararajan, Sophia; Hu, Yin C; Cordato, Dennis J; Manning, Nathan W; Hanel, Ricardo A; Aghaebrahim, Amin N; Budzik, Ronald F; Hicks, William J; Blasco, Jordi; Wu, Teddy Y; Tsai, Jenny P; Schaafsma, Joanna D; Gandhi, Chirag D; Al-Mufti, Fawaz; Sangha, Navdeep; Warach, Steven; Kleinig, Timothy J; Yogendrakumar, Vignan; Ng, Felix; Samaniego, Edgar A; Abdulrazzak, Mohammad A; Parsons, Mark W; Rahbar, Mohammad H; Nguyen, Thanh N; Fifi, Johanna T; Mendes Pereira, Vitor; Lansberg, Maarten G; Albers, Greg W; Furlan, Anthony J; Jabbour, Pascal.
Affiliation
  • Sarraj A; 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.
  • Abraham MG; Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.
  • Hassan AE; Department of Neuroscience, Valley Baptist Medical Center, Harlingen, TX, USA.
  • Blackburn S; Department of Neurosurgery, McGovern Medical School at UTHealth, Houston, TX, USA.
  • Kasner SE; Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.
  • Ortega-Gutierrez S; Department of Neurosurgery and Radiology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.
  • Hussain MS; Cerebrovascular Center, Cleveland Clinic, Cleveland, OH, USA.
  • Chen M; Department of Neurosurgery, Rush University Medical Center, Chicago, IL, USA.
  • Johns H; Department of Medicine and Neurology, University of Melbourne, Parkville, VC, Australia.
  • Churilov L; Department of Medicine and Neurology, University of Melbourne, Parkville, VC, Australia.
  • Pujara DK; Department of Neurology, University Hospital Cleveland Medical Center, Cleveland, OH, USA; Department of Neurology, Case Western Reserve University, Cleveland, OH, USA.
  • Shaker F; Department of Neurosurgery, McGovern Medical School at UTHealth, Houston, TX, USA.
  • Maali L; Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.
  • Cardona Portela P; Department of Neurology, Hospital Universitari de Bellvitge, Bellvitge, Spain.
  • Herial NA; Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
  • Gibson D; Department of Neurosurgery, Ascension Wisconsin, Indianapolis, IN, USA.
  • Kozak O; Department of Neurosurgery, Abington Jefferson Health, Abington, PA, USA.
  • Arenillas JF; Department of Internal Medicine, Hospital Clínico Universitario Valladolid-University of Valladolid, Valladolid, Spain.
  • Yan B; Department 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.
  • Pérez de la Ossa N; Department of Neurology, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
  • Sundararajan S; Department of Neurology, University Hospital Cleveland Medical Center, Cleveland, OH, USA; Department of Neurology, Case Western Reserve University, Cleveland, OH, USA.
  • Hu YC; Department of Neurosurgery, University Hospital Cleveland Medical Center, Cleveland, OH, USA; Department of Neurosurgery, Case Western Reserve University, Cleveland, OH, USA.
  • Cordato DJ; Department of Neurology, Liverpool Hospital, Liverpool, NSW, Australia.
  • Manning NW; Department of Neurosurgery, Ingham Institute, Liverpool, NSW, Australia.
  • Hanel RA; Department of Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, FL, USA.
  • Aghaebrahim AN; Department of Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, FL, USA.
  • Budzik RF; Department of Neuro-Interventional Radiology, OhioHealth-Riverside Methodist Hospital, Columbus, OH, USA.
  • Hicks WJ; Department of Neurology, OhioHealth-Riverside Methodist Hospital, Columbus, OH, USA.
  • Blasco J; Department of Interventional Radiology, Hospital Clínic de Barcelona, Barcelona, Spain.
  • Wu TY; Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.
  • Tsai JP; Cerebrovascular Center, Cleveland Clinic, Cleveland, OH, USA.
  • Schaafsma JD; Department of Internal Medicine, Toronto Western Hospital, Toronto, ON, Canada.
  • Gandhi CD; Department of Neurosurgery, Westchester Medical Center-NY Medical College, Valhalla, NY, USA.
  • Al-Mufti F; Department of Neurosurgery, Westchester Medical Center-NY Medical College, Valhalla, NY, USA.
  • Sangha N; Department of Neurology, Kaiser Permanente Southern California, Los Angeles, CA, USA.
  • Warach S; Department of Neurology, Dell Medical School at The University of Texas at Austin-Ascension Texas, Austin, TX, USA.
  • Kleinig TJ; Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia.
  • Yogendrakumar V; Department of Internal Medicine and Neurology, Melbourne Brain Center-The Royal Melbourne Hospital, Parkville, VC, Australia.
  • Ng F; Department of Internal Medicine and Neurology, Melbourne Brain Center-The Royal Melbourne Hospital, Parkville, VC, Australia.
  • Samaniego EA; Department of Neurosurgery and Radiology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.
  • Abdulrazzak MA; Cerebrovascular Center, Cleveland Clinic, Cleveland, OH, USA.
  • Parsons MW; Department of Neurology, Liverpool Hospital, Liverpool, NSW, Australia.
  • Rahbar MH; Department of Internal Medicine, McGovern Medical School at UTHealth, Houston, TX, USA.
  • Nguyen TN; Department of Neurology, Boston Medical Center, Boston, MA, USA.
  • Fifi JT; Department of Neurology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
  • Mendes Pereira V; Department of Neurology, St Michael's Hospital, Toronto, ON, Canada.
  • Lansberg MG; Department of Neurology, Stanford University, Stanford, CA, USA.
  • Albers GW; Department of Neurology, Stanford University, Stanford, CA, USA.
  • Furlan AJ; Department of Neurology, University Hospital Cleveland Medical Center, Cleveland, OH, USA; Department of Neurology, Case Western Reserve University, Cleveland, OH, USA.
  • Jabbour P; Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
Lancet ; 403(10428): 731-740, 2024 Feb 24.
Article in En | MEDLINE | ID: mdl-38346442
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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Full text: 1 Database: MEDLINE Main subject: Brain Ischemia / Stroke / Endovascular Procedures / Ischemic Stroke Type of study: Clinical_trials / Etiology_studies Limits: Humans Country/Region as subject: America do norte Language: En Year: 2024 Type: Article
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Full text: 1 Database: MEDLINE Main subject: Brain Ischemia / Stroke / Endovascular Procedures / Ischemic Stroke Type of study: Clinical_trials / Etiology_studies Limits: Humans Country/Region as subject: America do norte Language: En Year: 2024 Type: Article