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Original research
Direct mechanical thrombectomy in tPA-ineligible and -eligible patients versus the bridging approach: a meta-analysis
  1. Johannes Kaesmacher1,2,
  2. Pasquale Mordasini2,
  3. Marcel Arnold1,
  4. Elena López-Cancio3,
  5. Neus Cerdá4,
  6. Tobias Boeckh-Behrens5,
  7. Justus F Kleine6,
  8. Mayank Goyal7,
  9. Michael D Hill8,
  10. Vitor Mendes Pereira9,
  11. Jeffrey L Saver10,
  12. Jan Gralla2,
  13. Urs Fischer1
  1. 1 Department of Neurology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland
  2. 2 Institute of Diagnostic and Interventional Neuroradiology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland
  3. 3 Department of Neurology, Stroke Unit Hospital Universitario Central de Asturias (HUCA), Oviedo, Spain
  4. 4 Biostatistics Unit, Bioclever CRO, Barcelona, Spain
  5. 5 Institute of Diagnostic and Interventional Neuroradiology, Technical University Munich, Klinikum rechts der Isar, München, Germany
  6. 6 Institute of Neuroradiology, Berlin, Germany
  7. 7 Department of Diagnostic Imaging, University of Calgary, Calgary, Alberta, Canada
  8. 8 Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada
  9. 9 Division of Neuroradiology, Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada
  10. 10 Comprehensive Stroke Center, Geffen School of Medicine, University of California, Los Angeles, California, USA
  1. Correspondence to Dr Urs Fischer, Department of Neurology, University of Bern, Bern 3012, Switzerland; urs.fischer{at}insel.ch

Abstract

Background Whether pretreatment with intravenous thrombolysis prior to mechanical thrombectomy (IVT+MTE) adds additional benefit over direct mechanical thrombectomy (dMTE) in patients with large vessel occlusions (LVO) is a matter of debate.

Methods This study-level meta-analysis was presented in accord with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Pooled effect sizes were calculated using the inverse variance heterogeneity model and displayed as summary Odds Ratio (sOR) and corresponding 95% confidence interval (95% CI). Sensitivity analysis was performed by distinguishing between studies including dMTE patients eligible for IVT (IVT-E) or ineligible for IVT (IVT-IN). Primary outcome measures were functional independence (modified Rankin Scale≤2) and mortality at day 90, successful reperfusion, and symptomatic intracerebral hemorrhage.

Results Twenty studies, incorporating 5279 patients, were included. There was no evidence that rates of successful reperfusion differed in dMTE and IVT+MTE patients (sOR 0.93, 95% CI 0.68 to 1.28). In studies including IVT-IN dMTE patients, patients undergoing dMTE tended to have lower rates of functional independence and had higher odds for a fatal outcome as compared with IVT+MTE patients (sOR 0.78, 95% CI 0.61 to 1.01 and sOR 1.45, 95% CI 1.22 to 1.73). However, no such treatment group effect was found when analyses were confined to cohorts with a lower risk of selection bias (including IVT-E dMTE patients).

Conclusion The quality of evidence regarding the relative merits of IVT+MTE versus dMTE is low. When considering studies with lower selection bias, the data suggest that dMTE may offer comparable safety and efficacy as compared with IVT+MTE. The conduct of randomized-controlled clinical trials seems justified.

  • stroke
  • thrombectomy
  • thrombolysis

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Footnotes

  • Contributors All authors contributed to the presented work by substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work and drafting the work or revising it critically for important intellectual content and final approval of the version to be published and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

  • Funding The work of JK was supported by the SAMW/Bangerter Foundation through the Young Talents in Clinical Research Program. All other 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 Related: UF and JG are global PIs for the SWIFT DIRECT trial and are consultants for Medtronic. VMP is a PI for the SWIFT DIRECT trial and is a consultant for Medtronic. Unrelated: MA received honoraria for lectures and advisory boards from Bayer, Boehringer Ingelheim, Bristol Meyer Squibbs, Pfizer, and Covidien. MG is a consultant for Medtronic, Stryker, Microvention/ and Ablynx and received grants from Medtronic and Stryker provided to the University of Calgary. He has a licensing agreement with GE for systems of stroke diagnosis. MDH received a grant from Alberta Innovates for stroke program in Alberta. VMP is a consultant for Stryker (SC for DAWN trial), Penumbra (SC for PROMISE study), BALT (proctorship of products unrelated to ischemic stroke), Phenox, Rapid Medical, Neurovasc and receives research a grant from Philips. JLS is a consultant about trial design and conduct for Covidien and Stryker, and employee of the University of California, which holds a patent on retriever devices for stroke. JG is a global PI of STAR, CEC member of the PROMISE study (Penumbra), Consultancy; and receives SNSF grants for magnetic resonance imaging in stroke. UF receives research grants from Swiss National Science Foundation (SNSF). All other authors have nothing to disclose.

  • Patient consent Not required.

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

  • Data sharing statement Raw data and frequency counts can be found by accessing the provided Online Dataset 1.