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Ischemic stroke
Common design and data elements reported in active mechanical thrombectomy trials focusing on distal medium vessel occlusions and minor strokes: a systematic review
  1. Cem Bilgin1,
  2. Marisabel L Bolsegui2,
  3. Sherief Ghozy1,
  4. Amir Hassankhani1,
  5. Hassan Kobeissi1,
  6. Mohamed Sobhi Jabal1,
  7. Rishabh Gupta1,
  8. Gianluca De Rubeis3,
  9. Ramanathan Kadirvel1,4,
  10. Waleed Brinjikji1,
  11. Luca Saba5,
  12. David F Kallmes1
  1. 1Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
  2. 2Department of Vascular and Interventional Radiology, The Johns Hopkins University, Baltimore, Maryland, USA
  3. 3Department of Diagnostic, San Camillo Forlanini Hospital, Roma, Italy
  4. 4Department of Neurologic Surgery, Mayo Clinic, Rochester, Minnesota, USA
  5. 5Department of Medical Imaging, Università degli Studi di Cagliari, Cagliari, Sardegna, Italy
  1. Correspondence to Dr Cem Bilgin, Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA; bilgin.cem{at}mayo.edu

Abstract

Background Distal medium vessel occlusions (DMVOs) and minor strokes represent emerging frontiers in mechanical thrombectomy (MT). Although several randomized clinical trials (RCTs) are underway, the design characteristics of these trials and the specific questions they aim to address have not been extensively explored. This current study sought to investigate the design and data elements reported in active prospective DMVO and minor stroke studies.

Methods The ClinicalTrials.gov database was searched for ongoing prospective studies assessing the role of MT in patients with DMVOs or minor strokes. The Nested Knowledge AutoLit platform was utilized to categorize reported outcomes and inclusion/exclusion criteria. Frequencies of reported data elements were extracted from study protocols.

Results A total of 10 (8 DMVO and 2 minor stroke) studies enrolling 3520 patients were included. All DMVO studies employ different criteria regarding target occlusion locations. Five DMVO studies use stent retrievers as the first-line thrombectomy technique (62.5%, 5/8), while three studies allow any MT techniques, generally at the operator’s discretion. Four DMVO studies permit intravenous thrombolysis (IVT) utilization in both intervention and control arms (50%, 4/8). The DISTALS trial excludes patients receiving IVT, while the DUSK trial and Tigertriever registry only enroll patients who are ineligible for IVT or for whom IVT failed to achieve reperfusion. DMVO studies exhibit notable heterogeneity in symptom onset duration thresholds for inclusion (<6 hours: 2 studies; <12 hours: 2 studies; <24 hours: 3 studies). Minor stroke trials employ similar inclusion criteria and outcome measures except for symptom duration thresholds for inclusion (8 hours for ENDOLOW and 23 hours for MOSTE).

Conclusions There is considerable heterogeneity among active DMVO trials regarding potential target DMVO locations and time thresholds for inclusion based on the last known well time. Furthermore, our review indicates that the utility of aspiration thrombectomy in DMVOs and the advantages of MT without IVT over IVT alone will remain largely unexplored even after completion of active DMVO trials.

  • Stroke
  • Thrombectomy
  • Thrombolysis

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/jnis-2023-021073

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @cembilgincb, @SobhiJabal

    • Contributors All authors contributed to the conception and design of the work. CB, ML, HK, SG, and MSJ were responsible for data extraction, literature search, and risk of bias assessment. All authors were involved in the drafting of the article, critical revision of the article, and final approval of the version to be published. CB is responsible for the overall content as guarantor.

    • 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 RK received research support from Cerenovus Inc, Medtronic, Endovascular Engineering, Frontier Bio, Sensome Inc, Endomimetics, Ancure LLC, Neurogami Medical, MIVI Biosciences, Monarch Biosciences, Stryker, Conway Medical, Piraeus Medical, and Bionaut Labs. WB holds equity in Nested Knowledge, Superior Medical Experts, Piraeus Medical, Sonoris Medical, and MIVI Neurosciences; he receives royalties from Medtronic; he receives consulting fees from Medtronic, Stryker, Imperative Care, Microvention, MIVI Neurosciences, Cerenovus, Asahi, and Balt; he serves in a leadership or fiduciary role for MIVI Neurosciences, Marblehead Medical LLC, Interventional Neuroradiology (editor in chief), Piraeus Medical, and WFITN. DFK holds equity in Nested Knowledge, Superior Medical Experts, and Conway Medical, Marblehead Medical, and Piraeus Medical; he has received grant support from Microvention, Medtronic, Neurogami, Cerenovus, Brainomix, MIVI Neurosciences, Stryker, Balt, and Insera Therapeutics; he has served on the Data Safety Monitoring Board for Vesalio and NoNo Inc; and received royalties from Medtronic. The remaining authors report no conflicts of interest.

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