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Vascular neurology
Clinical relevance of intracranial hemorrhage after thrombectomy versus medical management for large core infarct: a secondary analysis of the SELECT2 randomized trial
  1. Michael Chen1,
  2. Krishna C Joshi2,
  3. Bradley Kolb3,
  4. Clark W Sitton4,
  5. Deep Kiritbhai Pujara5,
  6. Michael G Abraham6,
  7. Santiago Ortega-Gutierrez7,
  8. Scott E Kasner8,
  9. Shazam M Hussain9,
  10. Leonid Churilov10,
  11. Spiros Blackburn11,
  12. Sophia Sundararajan12,
  13. Yin C Hu13,
  14. Nabeel Herial14,
  15. Juan F Arenillas15,
  16. Jenny P Tsai16,
  17. Ronald F Budzik17,
  18. William Hicks18,
  19. Osman Kozak19,20,
  20. Bernard Yan21,
  21. Dennis Cordato22,23,
  22. Nathan W Manning24,25,
  23. Mark Parsons26,
  24. Ricardo A Hanel27,
  25. Amin Aghaebrahim28,
  26. Teddy Wu29,
  27. Pere Cardona Portela30,
  28. Chirag D Gandhi31,
  29. Fawaz Al-Mufti32,
  30. Natalia Perez de la Ossa33,
  31. Joanna Schaafsma34,
  32. Jordi Blasco35,
  33. Navdeep Sangha36,
  34. Steven Warach37,
  35. Timothy J Kleinig38,
  36. Hannah Johns10,
  37. Faris Shaker5,
  38. Mohammad A Abdulrazzak39,
  39. Abhishek Ray40,
  40. Jeffery Sunshine41,
  41. Amanda Opaskar12,
  42. Kelsey R Duncan12,
  43. Wei Xiong12,
  44. Faisal K Al-Shaibi12,
  45. Edgar A Samaniego42,
  46. Thanh N Nguyen43,
  47. Johanna T Fifi44,
  48. Stavropoula I Tjoumakaris14,
  49. Pascal Jabbour45,
  50. Vitor Mendes Pereira46,
  51. Maarten G Lansberg47,
  52. Cathy Sila48,49,
  53. Nicholas C Bambakidis50,
  54. Stephen Davis21,
  55. Lawrence Wechsler51,
  56. Gregory W Albers52,
  57. James C Grotta53,
  58. Marc Ribo54,55,
  59. Ameer E Hassan56,
  60. Bruce Campbell21,
  61. Michael D Hill57,58,
  62. Amrou Sarraj59
  1. 1Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA
  2. 2Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA
  3. 3Rush University Medical Center, Chicago, Illinois, USA
  4. 4Diagnostic & Interventional Imaging, UT Houston, Houston, Texas, USA
  5. 5Neurology, University of Texas McGovern Medical School, Houston, Texas, USA
  6. 6Neurology and Radiology, University of Kansas Medical Center, Kansas City, Kansas, USA
  7. 7Neuroloy, Neurosurgery and Radiology, The University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
  8. 8Neurology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
  9. 9Cleveland Clinic Stroke Program, Cleveland Clinic, Cleveland Heights, Ohio, USA
  10. 10University of Melbourne, Parkville, Victoria, Australia
  11. 11Neurosurgery, University of Texas Medical School at Houston Vivian L Smith Department of Neurosurgery, Houston, Texas, USA
  12. 12University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA
  13. 13Neurosurgery, University Hospitals Case Medical Center, Cleveland, Ohio, USA
  14. 14Neurological Surgery, Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania, USA
  15. 15Stroke Unit, Neurology Department, Stroke Unit. Neurology Department. Universitary Hospital, Valladolid (Spain), Valladolid, Spain
  16. 16Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA
  17. 17Riverside Methodist Hospital, Columbus, Ohio, USA
  18. 18OhioHealth Neurological Physicians, Riverside Methodist Hospital, Columbus, Ohio, USA
  19. 19Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
  20. 20Abington Memorial Hospital, Abington, Pennsylvania, USA
  21. 21The Royal Melbourne Hospital, Parkville, Victoria, Australia
  22. 22Department of Neurology and Neurophysiology, Liverpool Hospital, Liverpool, New South Wales, Australia
  23. 23Ingham Institute of Applied Medical Research, Sydney, New South Wales, Australia
  24. 24Institute of Neurosciences, UNSW Prince of Wales Clinical School, Sydney, New South Wales, Australia
  25. 25Advanced Endovascular Therapy, Florey Institute of Neuroscience and Mental Health, Melbourne, Victoria, Australia
  26. 26Liverpool Hospital, Liverpool, New South Wales, Australia
  27. 27Baptist Health, Jacksonville, Florida, USA
  28. 28Neurological Institute, Lyerley Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA
  29. 29Neurology, Christchurch Hospital, Christchurch, Canterbury, New Zealand
  30. 30Bellvitge University Hospital, L'Hospitalet de Llobregat, Catalunya, Spain
  31. 31Neurosurgery, Westchester Medical Center, Valhalla, New York, USA
  32. 32Neurology and Neurosurgery, Westchester Medical Center, Valhalla, New York, USA
  33. 33Stroke Unit, Department of Neurology, Hospital Germans Trias i Pujol, Barcelona, Spain
  34. 34Medicine - Div. Neurology, Toronto Western Hospital, Toronto, Ontario, Canada
  35. 35Neurointerventional Department C.D.I, Hospital Clinic de Barcelona, Barcelona, Spain
  36. 36Kaiser Permanente Southern California, Los Angeles, California, USA
  37. 37University of Texas at Austin Dell Seton Medical Center, Austin, Texas, USA
  38. 38Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
  39. 39Cleveland Clinic, Cleveland, Ohio, USA
  40. 40Neurological Surgery, University Hospitals, Cleveland, Ohio, USA
  41. 41Radiology, University Hospitals-Case Medical Center, Cleveland, Ohio, USA
  42. 42Neurology, The University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
  43. 43Neurology, Boston University School of Medicine, Boston, Massachusetts, USA
  44. 44Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA
  45. 45Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
  46. 46Division of Neuroradiology, Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, University Health Network - Toronto Western Hospital, Toronto, Ontario, Canada
  47. 47Department of Neurology, Stanford Stroke Center, Stanford University, Stanford, California, USA
  48. 48Neurological Institute, University Hospitals- Case Medical Center, Cleveland, Ohio, USA
  49. 49Neurology, Case Western Reserve University School of Medicine
  50. 50Neurological Surgery, University Hospitals Case Medical Center, Cleveland, Ohio, USA
  51. 51University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA
  52. 52Neurology & Neurological Sciences, Stanford University, Stanford, California, USA
  53. 53Neurology, Memorial Hermann Hospital/UT Houston, Houston, Texas, USA
  54. 54Stroke Unit, Neurology, Hospital Vall d'Hebron, Barcelona, Spain
  55. 55Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain
  56. 56Department of Neurology, University of Texas Rio Grande Valley, Harlingen, Texas, USA
  57. 57Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada
  58. 58Clinical Neurosciences, Foothills Medical Centre, Calgary, Alberta, Canada
  59. 59Neurology, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA
  1. Correspondence to Dr Amrou Sarraj, Neurology, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA; Amrou.sarraj{at}uhhospitals.org

Abstract

Background The incidence of intracerebral hemorrhage (ICH) and its effect on the outcomes after endovascular thrombectomy (EVT) for patients with large core infarcts have not been well-characterized.

Methods SELECT2 trial follow-up imaging was evaluated using the Heidelberg Bleeding Classification (HBC) to define hemorrhage grade. The association of ICH with clinical outcomes and treatment effect was examined.

Results Of 351 included patients, 194 (55%) and 189 (54%) demonstrated intracranial and intracerebral hemorrhage, respectively, with a higher incidence in EVT (134 (75%) and 130 (73%)) versus medical management (MM) (60 (35%) and 59 (34%), both P<0.001). Hemorrhagic infarction type 1 (HBC=1a) and type 2 (HBC=1b) accounted for 93% of all hemorrhages. Parenchymal hematoma (PH) type 1 (HBC=1c) and type 2 (HBC=2) were observed in 1 (0.6%) EVT-treated and 4 (2.2%) MM patients. Symptomatic ICH (sICH) (SITS-MOST definition) was seen in 0.6% EVT patients and 1.2% MM patients. No trend for ICH with core volumes (P=0.10) or Alberta Stroke Program Early CT Score (ASPECTS) (P=0.74) was observed. Among EVT patients, the presence of any ICH did not worsen clinical outcome (modified Rankin Scale (mRS) at 90 days: 4 (3–6) vs 4 (3–6); adjusted generalized OR 1.00, 95% CI 0.68 to 1.47, P>0.99) or modify EVT treatment effect (Pinteraction=0.77).

Conclusions ICH was present in 75% of the EVT population, but PH or sICH were infrequent. The presence of any ICH did not worsen functional outcomes or modify EVT treatment effect at 90-day follow-up. The high rate of hemorrhages overall still represents an opportunity for adjunctive therapies in EVT patients with a large ischemic core.

  • Thrombectomy
  • Hemorrhage
  • Complication
  • Stroke
  • Thrombolysis

Data availability statement

The individual patient data will not be made available. After a written request to the corresponding author is reviewed and approved by the steering committee, statistical codes and outputs will be made available for the purpose of reproducing results.

https://doi.org/10.1136/jnis-2023-021219

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    Data availability statement

    The individual patient data will not be made available. After a written request to the corresponding author is reviewed and approved by the steering committee, statistical codes and outputs will be made available for the purpose of reproducing results.

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    Footnotes

    • Twitter @dr_mchen, @Michael3Abraham, @CerebrovascLab, @@NabeelHerial, @JPTsaiMD, @DrPatchiz, @drnimajax, @almuftifawaz, @TimothyKleinig, @Faris_Shaker, @esamaniego, @NguyenThanhMD, @stavtjouamakris, @PascalJabbourMD, @VitorMendesPer1, @marcriboj, @mihill68, @amrsarrajMD

    • Contributors MC and KJ wrote the first draft of the report, with inputs from MH, BC, DP and AS. DP performed statistical analyses. All authors had full access to all the included data and all authors had final responsibility for the decision to submit for publication. AS accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

    • Funding SELECT2 trial was funded by Stryker Neurovascular through institutional grants to University Hospitals Cleveland Medical Center and UT McGovern Medical School. This secondary analysis of the SELECT2 trial did not receive any funding.

    • Competing interests MC has received consulting fees from Medtronic and Microvention. AH has received grants from RESCUE - ICAD – Medtronic. He has also reported consulting fees from Medtronic, Microvention, Stryker, and Cerenovus. SO-G has received grants from Stryker Neurovascular and Microvention. He has also received modest consulting fees from Medtronic, Stryker Neurovascular, and Microvention. JB is a member of the speakers’ bureau for Stryker Neurovascular and Microvention, and holds leadership roles in Inspire S and A registries (Medtronics). TNN is a DSMB member for the SELECT2 trial and has received grants from Medtronic. SD is a DSMB member for the SELECT2 trial and on the advisory board for Medtronic. JF and LW are DSMB members for the SELECT2 trial. GA reports compensation from iSchemaView for consultant services; and stock holdings in iSchemaView. AS has received grant support from Stryker Neurovascular for the SELECT2 trial. He is also a member of the speaker’s bureau and advisory board for Stryker Neurovascular. The other authors have no competing interest relevant to this study.

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

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.