Article Text

PDF
Original research
TREVO stent-retriever mechanical thrombectomy for acute ischemic stroke secondary to large vessel occlusion registry
  1. Osama O Zaidat1,2,
  2. Alicia C Castonguay3,
  3. Raul G Nogueira4,
  4. Diogo C Haussen4,
  5. Joey D English5,
  6. Sudhakar R Satti6,
  7. Jennifer Chen7,
  8. Hamed Farid8,
  9. Candace Borders9,
  10. Erol Veznedaroglu10,
  11. Mandy J Binning10,
  12. Ajit Puri11,
  13. Nirav A Vora12,
  14. Ron F Budzik12,
  15. Guilherme Dabus13,
  16. Italo Linfante13,
  17. Vallabh Janardhan14,
  18. Amer Alshekhlee15,
  19. Michael G Abraham16,
  20. Randall Edgell17,
  21. Muhammad Asif Taqi18,
  22. Ramy El Khoury19,
  23. Maxim Mokin20,
  24. Aniel Q Majjhoo21,
  25. Mouhammed R Kabbani22,
  26. Michael T Froehler23,
  27. Ira Finch24,
  28. Sameer A Ansari25,
  29. Roberta Novakovic26,
  30. Thanh N Nguyen27
  1. 1Departments of Endovascular Neurosurgery and Stroke, St Vincent Mercy Medical Center, Toledo, Ohio, USA
  2. 2Neuroscience & Stroke Center, Mercy Health St Vincent Hospital, Toledo, OH, USA
  3. 3Department of Biostatistics, University of Texas, Houston, Texas, USA
  4. 4Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA
  5. 5California Pacific Medical Center, Atlanta, Florida, USA
  6. 6Department of Neurointerventional Surgery, Christiana Care Health System, Newark, Delaware, USA
  7. 7Sidney Kimmel Medical College, Philadelphia, Pennsylvania, USA
  8. 8Department of Neurointerventional Radiology, St Jude Medical Center, Fullerton, USA
  9. 9University of California, Irvine School of Medicine, Irvine, California, USA
  10. 10Department of Neurosurgery, Drexel Neurosciences Institute, Philadelphia, Pennsylvania, USA
  11. 11Department of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA
  12. 12Department of Radiology, Riverside Radiology and Interventional Associates, Columbus, Ohio, USA
  13. 13Department of Neurointerventional Surgery, Baptist Cardiac and Vascular Institute, Miami, Florida, USA
  14. 14Texas Stroke Institute, Plano, Texas, USA
  15. 15Department of Vascular and Interventional Neurology, DePaul Stroke Center-SSM Neuroscience Institutes, St Louis University, St Louis, Missouri, USA
  16. 16Departments of Neurology and Interventional Radiology, University of Kansas Medical Center, Kansas, USA
  17. 17Department of Neurology, St Louis University, St Louis, Missouri, USA
  18. 18Department of Neurology and Neurosurgery, Los Robles Hospital and Medical Center, Thousand Oaks, California, USA
  19. 19Department of Neurology, Tulane University, New Orleans, Louisiana, USA
  20. 20Department of Neurosurgery and Brain Repair, University of South Florida, Tampa, Florida, USA
  21. 21Department of Neurology, Wayne State School of Medicine, Detroit, Michigan, USA
  22. 22Department of Neurosurgery, Gundersen Health System, La Crosse, Wisconsin, USA
  23. 23Departments of Neurology, Neurosurgery, and Radiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  24. 24John Muir Health, Walnut Creek, California, USA
  25. 25Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA
  26. 26Departments of Radiology, Neurology, and Neurotherapeutics, UT Southwestern Medical Center, Dallas, Texas, USA
  27. 27Department of Neurology, Neurosurgery, and Radiology, Boston Medical Center, Boston, Massachusetts, USA
  1. Correspondence to Dr Osama O Zaidat, Director Neuroscience & Stroke Program Mercy Health St.Vincent Hospital, Toledo 43608, Ohio, USA; ozaidat{at}hotmail.com

Abstract

Background Recent randomized clinical trials (RCTs) demonstrated the efficacy of mechanical thrombectomy using stent-retrievers in patients with acute ischemic stroke (AIS) with large vessel occlusions; however, it remains unclear if these results translate to a real-world setting. The TREVO Stent-Retriever Acute Stroke (TRACK) multicenter Registry aimed to evaluate the use of the Trevo device in everyday clinical practice.

Methods Twenty-three centers enrolled consecutive AIS patients treated from March 2013 through August 2015 with the Trevo device. The primary outcome was defined as achieving a Thrombolysis in Cerebral Infarction (TICI) score of ≥2b. Secondary outcomes included 90-day modified Rankin Scale (mRS), mortality, and symptomatic intracranial hemorrhage (sICH).

Results A total of 634patients were included. Mean age was 66.1±14.8 years and mean baseline NIH Stroke Scale (NIHSS) score was 17.4±6.7; 86.7% had an anterior circulation occlusion. Mean time from symptom onset to puncture and time to revascularization were 363.1±264.5 min and 78.8±49.6 min, respectively. 80.3% achieved TICI ≥2b. 90-day mRS ≤2 was achieved in 47.9%, compared with 51.4% when restricting the analysis to the anterior circulation and within 6 hours (similar to recent AHA/ASA guidelines), and 54.3% for those who achieved complete revascularization. The 90-day mortality rate was 19.8%. Independent predictors of clinical outcome included age, baseline NIHSS, use of balloon guide catheter, revascularization, and sICH.

Conclusion The TRACK Registry results demonstrate the generalizability of the recent thrombectomy RCTs in real-world clinical practice. No differences in clinical and angiographic outcomes were shown between patients treated within the AHA/ASA guidelines and those treated outside the recommendations.

  • stroke
  • stent-retriever
  • trevo
  • mechanical
  • thrombectomy
  • revascularization

Statistics from Altmetric.com

Footnotes

  • Contributors All authors participated in the design, conception, data gathering, writing, meaningful editing, suggestions, and feedback on the final manuscript.

  • Funding Stryker Neurovascular; limited coordinating center administrative grant. No per patient cost was provided.

  • Competing interests IL is consultant for Metronic, Stryker, Penumbra, and Cordis. MM is consultant for Claret Medical, Nogueira-Stryker Neurovascular (Trevo-2 Trial Principal Investigator – modest; DAWN Trial Principal Investigator – no compensation, TREVO Registry Steering Committee – no compensation), Medtronic (SWIFT Trial Steering Committee – modest; SWIFT-Prime Trial Steering Committee – no compensation; STAR Trial Angiographic Core Lab – significant), Penumbra (3D Separator Trial Executive Committee – no compensation), Neuravi (ARISE-2 Steering Committee – no compensation), Genentech (Physician Advisory Board – modest), Allm Inc (Physician Advisory Board – no compensation), Editor-In-Chief Interventional Neurology Journal (no compensation). SRS is a consultant for Stryker Neurovascular. OOZ is overall PI for TRACK – no compensation, Arise II – modest, Co-PI Therapy Trial – modest, Steering committee STRATIS registry – modest.

  • Ethics approval Ethics approval was provided by Mercy Health St. Vincent Hospital institutional review board and the ethics committee at each participating institution.

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

  • Data sharing statement There are no additional unpublished data from this particular study comparing the post marketing experience of the TREVO device with the industry sponsored prospective study. Additional questions are being addressed by other sub-papers currently under development.

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.