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  • Neuro Elutax SV drug-eluting balloon versus Wingspan stent system in symptomatic intracranial high-grade stenosis: a single-center experience

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Ischemic Stroke
Original research
Neuro Elutax SV drug-eluting balloon versus Wingspan stent system in symptomatic intracranial high-grade stenosis: a single-center experience
  1. Philipp Gruber1,2,
  2. Carlos Garcia-Esperon2,
  3. Jatta Berberat1,
  4. Timo Kahles2,
  5. Martin Hlavica1,
  6. Javier Anon1,
  7. Michael Diepers1,
  8. Krassen Nedeltchev2,
  9. Luca Remonda1
  1. 1 Department of Neuroradiology, Cantonal Hospital, Aarau, Switzerland
  2. 2 Department of Neurology, Cantonal Hospital, Aarau, Switzerland
  1. Correspondence to Dr Philipp Gruber, Department of Neuroradiology, Cantonal Hospital, Aarau 5001, Switzerland; philipp.gruber{at}ksa.ch

Abstract

Background Intracranial atherosclerotic disease is a well-known cause of ischemic stroke. Following the SAMMPRIS trial, medical treatment is favored over stenting. Drug-eluting balloons (DEB) are widely used in coronary angioplasty, showing better results than bare-surface balloons. There is little evidence of DEB employment in intracranial stenosis, especially of paclitaxel-eluted balloons (pDEB). The Neuro Elutax SV (Aachen Resonance) is the first CE certificated pDEB for intracranial use.

Objective To compare pDEB Neuro Elutax SV (ElutaxDEB) with the Wingspan/Gateway stent system (WingspanStent).

Materials and methods A single-center, open-label, retrospective cohort study of 19 patients with symptomatic atherosclerotic intracranial high-grade stenosis treated with either ElutaxDEB or WingspanStent from a tertiary stroke center in Switzerland.

Results Eight patients (42%) received ElutaxDEB. Median clinical follow-up was 10 months for the WingspanStent and 9.5 months for ElutaxDEB (P=0.36). No differences were found in the clinical baseline characteristics, with a median stenosis grade of 80% for the WingspanStent and 81% for the ElutaxDEB (P=0.87). The compound endpoint ‘ischemic re-event and/or restenosis’ was significantly lower for ElutaxDEB (13% vs 64%; P=0.03, OR 0.08 (95% CI 0.007 to 0.93; P=0.043) than for the WingspanStent.

Conclusions The ElutaxDEB may be a promising alternative treatment for patients with symptomatic high-grade intracranial stenosis showing a significantly lower rate of ischemic re-events or restenosis in comparison with the WingspanStent-treated patients with a similar safety profile. Further studies will be needed to definitively elucidate the role of pDEB in the management of symptomatic intracranial high-grade stenosis.

  • angioplasty
  • balloon
  • atherosclerosis
  • stenosis
  • stroke

https://doi.org/10.1136/neurintsurg-2017-013699

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    Footnotes

    • Contributors PG made substantial contributions to the conception and design of the work, and to acquisition, analysis, and interpretation of data for the work; CG-E, JB, TK made substantial contributions to the conception and design of the work, and revised it critically for important intellectual content; MH, JA, MD, KN revised the paper critically for important intellectual content; LR conceived and designed the work, revising it critically for important intellectual content, and gave final approval of the version to be published.

    • 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 None declared.

    • Patient consent Not required.

    • Ethics approval EKNZ.

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