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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. 1Department of Neuroradiology, Cantonal Hospital, Aarau, Switzerland
  2. 2Department 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

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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.

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