title: Endovascular therapy for acute ischaemic stroke: the Pragmatic Ischaemic Stroke Thrombectomy Evaluation (PISTE) randomised, controlled trial.
abstract: OBJECTIVE
  The Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA).
  
  
  METHODS
  Eligible patients had IVT started within 4.5 hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90 min. The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale (mRS) score of 0-2 at day 90.
  
  
  RESULTS
  Ten UK centres enrolled 65 patients between April 2013 and April 2015. Median National Institutes of Health Stroke Scale score was 16 (IQR 13-21). Median stroke onset to IVT start was 120 min. In the intention-to-treat analysis, there was no significant difference in disability-free survival at day 90 with MT (absolute difference 11%, adjusted OR 2.12, 95% CI 0.65 to 6.94, p=0.20). Secondary analyses showed significantly greater likelihood of full neurological recovery (mRS 0-1) at day 90 (OR 7.6, 95% CI 1.6 to 37.2, p=0.010). In the per-protocol population (n=58), the primary and most secondary clinical outcomes significantly favoured MT (absolute difference in mRS 0-2 of 22% and adjusted OR 4.9, 95% CI 1.2 to 19.7, p=0.021).
  
  
  CONCLUSIONS
  The trial did not find a significant difference between treatment groups for the primary end point. However, the effect size was consistent with published data and across primary and secondary end points. Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe, improves excellent clinical outcomes and, in the per-protocol population, improves disability-free survival.
  
  
  BACKGROUND
  NCT01745692; Results.
authors.affiliation: Institute of Neuroscience & Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.
authors.forename: Keith W
authors.initials: KW
authors.lastname: Muir
authors.affiliation: Division of Medical Sciences, Oxford University Hospitals NHS Trust, Oxford University, Oxford, UK.
authors.forename: Gary A
authors.initials: GA
authors.lastname: Ford
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
authors.forename: Claudia-Martina
authors.initials: CM
authors.lastname: Messow
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Ford
authors.affiliation: Institute of Neuroscience & Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.
authors.forename: Alicia
authors.initials: A
authors.lastname: Murray
authors.affiliation: St George's, University of London, London, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Clifton
authors.affiliation: Stroke Research Centre, UCL Institute of Neurology, University College London, London, UK.
authors.forename: Martin M
authors.initials: MM
authors.lastname: Brown
authors.affiliation: St George's, University of London, London, UK.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Madigan
authors.affiliation: Department of Neuroradiology, Queen's Medical Centre, Nottingham, UK.
authors.forename: Rob
authors.initials: R
authors.lastname: Lenthall
authors.affiliation: Stroke Research Centre, UCL Institute of Neurology, University College London, London, UK.
authors.forename: Fergus
authors.initials: F
authors.lastname: Robertson
authors.affiliation: Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Anand
authors.initials: A
authors.lastname: Dixit
authors.affiliation: St George's, University of London, London, UK.
authors.forename: Geoffrey C
authors.initials: GC
authors.lastname: Cloud
authors.affiliation: Brain Research Imaging Centre, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
authors.forename: Joanna
authors.initials: J
authors.lastname: Wardlaw
authors.affiliation: Lay member, Cornwall, UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Freeman
authors.affiliation: Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Philip
authors.initials: P
authors.lastname: White
mesh_terms: D061605:Administration, Intravenous; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020521:Stroke / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D016019:Survival Analysis; D017131:Thrombectomy; D015912:Thrombolytic Therapy; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D010959:Tissue Plasminogen Activator