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SELECTion criteria for large core trials: dogma or data?
  1. Amrou Sarraj1,
  2. Bruce Campbell2,
  3. Marc Ribo3,
  4. Muhammad Shazam Hussain4,
  5. Michael Chen5,
  6. Michael G Abraham6,
  7. Maarten G Lansberg7,
  8. Vitor Mendes Pereira8,
  9. Spiros Blackburn9,
  10. Clark W Sitton10,
  11. Ronald F Budzik11,
  12. Natalia Pérez de la Ossa12,
  13. Juan F Arenillas13,
  14. Teddy Wu14,
  15. Jordi Blasco15,
  16. Michael Mullen16,
  17. Joanna Schaafsma17,
  18. Jenny P Tsai18,
  19. Navdeep Sangha19,
  20. Osman Kozak20,
  21. Daniel Gibson21,
  22. Steven Warach22,
  23. Dennis Cordato23,
  24. Nathan W Manning23,
  25. Timothy J Kleinig24,
  26. Jean-Marc Olivot25,
  27. Lucas Elijovich26,
  28. Georgios Tsivgoulis26,27,
  29. Andrei Alexandrov26,
  30. Pascal Jabbour28,
  31. Bernard Yan2,
  32. Scott E Kasner16,
  33. Adam S Arthur29,
  34. Mark Parsons23,
  35. James C Grotta30,
  36. Ameer E Hassan31,
  37. Gregory W Albers7
  38. On behalf of SELECT2 Investigators and SELECT2 Steering Committee
  1. 1 Neurology, University of Texas McGovern Medical School, Houston, Texas, USA
  2. 2 The Royal Melbourne Hospital, Melbourne, Victoria, Australia
  3. 3 Neurology, Hospital Vall d'Hebron, Barcelona, Spain
  4. 4 Neurology, Cleveland Clinic, Cleveland, Ohio, USA
  5. 5 Neurology, Rush University Medical Center, Chicago, Illinois, USA
  6. 6 Neurology, University of Kansas Medical Center, Kansas City, Kansas, USA
  7. 7 Neurology & Neurological Sciences, Stanford University, Stanford, California, USA
  8. 8 Surgery, Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada
  9. 9 Neurosurgery, University of Texas McGovern Medical School, Houston, Texas, USA
  10. 10 Neuroradiology, University of Texas McGovern Medical School, Houston, Texas, USA
  11. 11 Neurology, Riverside Methodist Hospital, Columbus, Ohio, USA
  12. 12 Stroke Unit, Department of Neurology, Hospital Universitari Germans Trias i Pujol, Badalona, Spain
  13. 13 Stroke Unit, Neurology Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
  14. 14 Neurology, Christchurch Hospital, Christchurch, New Zealand
  15. 15 Interventional Neuroradiology, Hospital Clinic de Barcelona, Barcelona, Spain
  16. 16 Neurology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
  17. 17 Medicine, Division of Neurology, Toronto Western Hospital, Toronto, Ontario, Canada
  18. 18 Department of Neurological Surgery, Spectrum Health Medical Group, Grand Rapids, Michigan, USA
  19. 19 Kaiser Permanente Southern California, Los Angeles, California, USA
  20. 20 Neurosurgery, Jefferson Health - Abington, Abington, Pennsylvania, USA
  21. 21 Ascension Wisconsin, Milwaukee, Wisconsin, USA
  22. 22 Neurology, University of Texas at Austin Dell Seton Medical Center, Austin, Texas, USA
  23. 23 Neurology, Liverpool Hospital, Liverpool, New South Wales, Australia
  24. 24 Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
  25. 25 Stroke Unit, University Hospital Centre Toulouse, Toulouse, France
  26. 26 Neurology, The University of Tennessee Health Science Center, Memphis, Tennessee, USA
  27. 27 Second Department of Neurology, “Attikon” Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece
  28. 28 Neurological Surgery, Thomas Jefferson University Hospitals, Wayne, Pennsylvania, USA
  29. 29 Neurosurgery, The University of Tennessee Health Science Center, Memphis, Tennessee, USA
  30. 30 Neurology, Memorial Hermann Hospital - Texas Medical Center, Houston, Texas, USA
  31. 31 Department of Neurology, University of Texas Rio Grande Valley, Harlingen, Texas, USA
  1. Correspondence to Dr Amrou Sarraj, Neurology, University of Texas McGovern Medical School, Houston, TX 77030, USA; Amrou.Sarraj{at}uth.tmc.edu

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We thank the Editors of JNIS for alerting us in advance to the concerns about SELECT2 raised by Jadhav1 and colleagues and appreciate the opportunity to explain the rationale for the study design and clarify the benefits of including perfusion imaging-based selection criteria. We are confident that SELECT2 will provide high-level, reliable data regarding the safety and efficacy of endovascular thrombectomy (EVT) for large core patients.

The choice of imaging modality for identifying large core in acute ischemic stroke remains an area of considerable debate. Magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), computed tomography (CT) or MR perfusion imaging and Alberta Stroke Program Early CT Score (ASPECTS) have all been proposed and studied. At present, there is no clear consensus on which imaging modality is best for identifying patients with large core. It is important to recognize that the early window randomized EVT trials used a broad range of imaging selection criteria. The imaging selection criteria for the initial five pivotal trials ranged from allowing patients to be enrolled regardless of the degree of early infarct signs,2 to studies that required a specific ASPECTS score range in addition to other imaging criteria,3–5 to EXTEND IA6 where the ASPECTS score was not considered, and CT perfusion (CTP) mismatch with a maximum estimated core size was required. All five trials were successful but with substantial variability in the treatment effect, leaving uncertainty as to the optimal imaging approach as well as whether there are patient subgroups who do not benefit. In fact, those utilizing perfusion mismatch criteria (EXTEND-IA, SWIFT PRIME) had higher rates of modified Rankin Scale (mRS) scores 0–2 and larger treatment effects, compared with other trials.2–6

Even if a treatment has a clear benefit in most patients, there can be important subgroups that do not …

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Footnotes

  • Twitter @amrsarrajMD, @marcriboj, @dr_mchen, @VitorMendesPer1, @DrPatchiz, @PascalJabbourMD, @AdamArthurMD

  • Collaborators SELECT2 Investigators and SELECT2 Steering Committee.

  • Contributors AS designed and drafted the manuscript and provided administrative support. GWA designed and drafted the manuscript and provided critical revisions. BC, MR, MSH, MC, MGA, MGL, VMP, SB, CWS, RFB, NPO, JFA, TW, JB, MM, JS, JPT, NS, OK, DG, SW, DC, NWM, TJK, JMO, LE, GT, AA, PJ, BY, SEK, ASA, MP, JCG, and AEH provided critical revisions to the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests AS reports serving as the Principal Investigator (PI) for SELECT, SELECT2, a site PI for DEFUSE 3, and a speaker bureau and advisory board member in Stryker. MR reports serving as a site PI and steering committee member for SELECT2, and holds consulting agreement for Medtronic, Stryker, Cerenovus, Anaconda Biomed, Apta Targets, Sanofi, and reports serving as a speakers bureau member for: Philips, UCB Pharma, Ischemia View, and reports ownership in Anaconda Biomed, and Methinks. MSH reports receiving fees for consulting for Cerenovus, and reports serving as a member on DSMB for Rapid Medical, and DSMB for Cerenovus, and a steering committee member and a site PI for SELECT2. MGL reports serving as a steering committee member for SELECT2, and PI for DEFUSE 3. BY reports serving as a co-PI for SELECT2 and DIRECTS SAFE. JFA reports having received honoraria as speaker/consultant for the following companies: BI, Pfizer, Daiichi, Bayer, Amgen, and Medtronic; and reports serving as a site PI on SELECT2. The institutions where JFA works have received research funding from Spanish Ministry of Economy, European Comission, and Castilla y León Departments of Health and Education. JMO receives consulting fees from Aptoll, Abbvie, Medtronic, and reports receiving speaker fees from Pfizer, Bristol Myers Squibb. LE reports serving as a site PI on SELECT2 and a sonsultant for Cerenovus, Medtronic, VizAI, Microvention, and Scientia. AA reports serving as a speaker bureau member and consultant for NovaSignal, Longeviti, and Siemens. NW Manning reports serving as a site PI on SELECT2, and a consultant for Balt, Stryker, Microvention and Medtronic. CWS reports serving as an Imaging Core Lab member for SELECT and SELECT2. SEK reports serving as a site PI on SELECT2, and reports receiving consultant fees from Medtronic, receiving grants non-relevant to this work from WL Gore, Medtronic, Bristol-Myers Squibb, and other fees from Bristol-Myers Squibb (consultant), Abbvie (consultant), UpToDate (royalties), and Elsevier (royalties). ASA reports serving as a consultant for Balt, Johnson and Johnson, Medtronic, Microvention, Penumbra, Scientia, Siemens, Stryker, and reports receiving research support from Balt, Medtronic, Microvention, Penumbra, and Siemens, and is a shareholder at Azimuth, Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Mentice, Neurogami, Serenity, Synchron, Triad Medical, and Truvic. MP reports research partnership with Siemens, Apollo Medical Imaging, and Canon; and reports serving as an advisory boards member for Medtronic, Boehringer Ingelheim. AEH reports serving as a consultant/speaker for Medtronic, Microvention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt; a site PI on SELECT2 and COMPLETE study – Penumbra, LVO SYNCHRONISE; steering committee/publication committee member for SELECT, DAWN, SELECT2, EXPEDITE II, EMBOLISE, CLEAR; a Proctor for Pipeline, FRED, Wingspan, and Onyx; and is supported by grants from GE Healthcare, Valley Baptist. GWA reports serving as a steering committee member for SELECT2, PI for DEFUSE 3, and reports receiving consulting fees for iSV and Genentech and has equity interest in iSV. BC, MGA, MC, SB, RFB, NPO, TW, JB, MM, JS, JPT, NS, OK, DG, SW, DC, and TJK report serving as site PIs for SELECT2. VMP, GT, PJ, and JCG report no relevant disclosures and no conflicts of interest to this work.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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    Ashutosh P Jadhav Werner Hacke Diederik W J Dippel Claus Ziegler Simonsen Vincent Costalat Jens Fiehler Goetz Thomalla Martin Bendszus Tommy Andersson Heinrich Paul Mattle Thabele M Leslie-Mazwi Maxim Mokin Albert J Yoo Osama O Zaidat Sunil A Sheth Tudor G Jovin David Liebeskind