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

Gruber, Philipp; García-Esperón, Carlos; Berberat, Jatta; Kahles, Timo; Hlavica, Martin; Añon, Javier; Diepers, Michael; Nedeltchev, Krassen; Remonda, Luca

doi:10.1136/neurintsurg-2017-013699

Cited by 46 publications

(52 citation statements)

References 31 publications

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“…In addition, no complications with DCB-PTA occurred in that study 12. The results of the present study using the SeQuent Please NEO DCB system further support these observations.…”

Section: Discussionsupporting

confidence: 85%

“…A recent study showed that Neuro Elutax SV, a specifically dedicated DCB for intracranial use, had similar effectiveness and lower restenosis rates than Wingspan stents in patients with symptomatic high-grade stenosis 12. In addition, no complications with DCB-PTA occurred in that study 12.…”

Section: Discussionmentioning

confidence: 91%

“…Antiproliferative agents, such as the highly lipophilic microtubular stabilizer paclitaxel, prevent neointimal hyperplasia by inhibiting migration and cell division (figure 1). 11 A recent retrospective study of 19 patients with symptomatic ICAD showed promising results for a paclitaxel-coated DCB compared with the Wingspan stent system, with a lower recurrence rate 12…”

Section: Introductionmentioning

confidence: 99%

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Percutaneous transluminal angioplasty using the novel drug-coated balloon catheter SeQuent Please NEO for the treatment of symptomatic intracranial severe stenosis: feasibility and safety study

Gruber

Braun

Kahles

et al. 2018

J NeuroIntervent Surg

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ObjectivesIntracranial arteriosclerotic disease is a relevant cause of ischemic stroke worldwide with a high recurrence rate despite best medical treatment. Following the SAMMPRIS trial, endovascular treatment has remained a second-line therapy. Meanwhile, there has been significant advances in device technology. SeQuent Please NEO is a novel polymer-free, drug-coated (paclitaxel/iopromide) balloon (DCB) primarily designed for cardiology. Because of its high flexibility and pushability, it may also be suitable for intracranial use. The aim of this study was to assess the feasibility and safety of SeQuent Please NEO DCB in symptomatic intracranial severe stenosis.MethodsA single-center retrospective cohort study of patients with symptomatic intracranial severe stenosis treated with SeQuent Please NEO DCB was performed at a tertiary stroke center.ResultsTen patients (all men, median age 73 years (IQR 69–77)) were included. Median pre-treatment stenosis grade was 78% (IQR 75–80%) with four internal carotid artery, two mid-basilar artery, and four vertebral artery lesions. Median post-treatment stenosis grade was 50% (IQR 45–53%). Successful angioplasty was achieved in all cases without technical failure. There were no cases of peri-procedural reocclusion and no deaths at median follow-up of 3 months (IQR 2–3).ConclusionIn this pilot study, SeQuent Please NEO DCB was feasible and safe in the treatment of symptomatic intracranial severe stenosis. It might represent a promising alternative to medical treatment in selected cases.

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“…In addition, no complications with DCB-PTA occurred in that study 12. The results of the present study using the SeQuent Please NEO DCB system further support these observations.…”

Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 91%

Section: Introductionmentioning

confidence: 99%

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Percutaneous transluminal angioplasty using the novel drug-coated balloon catheter SeQuent Please NEO for the treatment of symptomatic intracranial severe stenosis: feasibility and safety study

Gruber

Braun

Kahles

et al. 2018

J NeuroIntervent Surg

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“…Recent research suggested that a paclitaxel DCB is a viable alternative to drug-eluting stents,17 with the added advantage of avoiding a permanent implant. The new advent of Neuro Elutax DCB further increased the feasibility of using a DCB in intracranial arteries 18. However, the application of a DCB has not been systematically explored for intracranial de novo atherosclerosis disease.…”

Section: Introductionmentioning

confidence: 99%

Drug-coated balloons for the treatment of symptomatic intracranial atherosclerosis: initial experience and follow-up outcome

Han

Zhang

Xiao

et al. 2018

J NeuroIntervent Surg

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BackgroundThe optimal treatment for patients with symptomatic severe intracranial atherosclerotic disease is not well established. Angioplasty and stenting have been attempted, with controversial results, mainly attributed to perioperative complications and a high incidence of restenosis or in-stent restenosis. Drug-coated balloons (DCBs) have shown encouraging results for coronary and peripheral artery disease, without convincing data for intracranial vasculature.ObjectivesTo assess the feasibility, clinical and angiographic outcomes of DCBs for patients with intracranial de novo atherosclerotic disease.MethodsBetween September 2016 and September 2017, details of 30 patients with 31 arteries treated with DCBs for symptomatic severe intracranial atherosclerotic disease (≥70% stenosis or chronic total occlusion) were retrospectively collected in our centre. All lesions were predilated with conventional balloons. Periprocedural complications and clinical and vascular imaging follow-up outcomes were analysed.ResultsAll arteries were successfully dilated with DCBs and 29 (93.5%) arteries achieved good antegrade perfusion, with remedial stenting for two arteries. Two patients presented with new ischemic stroke after the procedure. Over a mean follow-up of 9.8±2.6 months, no patient had recurrent ischemic symptoms. Repeat vascular imaging was performed at 7.0±1.1 months, with cerebral angiography in 24 patients (25 arteries) and MR angiography in six patients (six arteries). Only one (3.2%) artery presented with angiographic asymptomatic restenosis.ConclusionsThis study suggests that DCB dilatation may be a safe and effective alternative for intracranial de novo atherosclerotic disease.

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“…Case series demonstrated the technical feasibility and good results regarding angiographic recurrence rates also with respect to ICAS [47,48]. In a retrospective comparison, the paclitaxelcoated Elutax DEB (drug-eluting balloon) (Aachen Resonance, Aachen, Germany) even showed a clear superiority over the Wingspan stent with respect to clinical recurrence and angiographic restentosis rate [49]. In a retrospective comparison of two drugeluting stents (DES), 100 successful procedures showed a low restenosis rate of 3.6 % exclusively after treatment with zotarolimus-coated Resolute Integrity TM (Medtronic Inc., Santa Rosa, CA, USA), and in no single case after treatment using paclitaxelcoated Taxus Element TM (Boston Scientific Corporation, Natick, MA, USA).…”

Section: Drug-coated Balloons and Stentsmentioning

confidence: 93%

Endovascular Treatment of Intracranial Atherosclerotic Stenosis

Nordmeyer

Chapot

Haage

2019

Fortschr Röntgenstr

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Background Intracranial atherosclerotic stenosis (ICAS) causes 5 – 10 % of all ischemic strokes in the European population. Indication for endovascular treatment is a special challenge and the selection of material as well as interventional techniques essentially differs from the treatment of extracranial stenoses. According to recent studies patient selection became evidence based; however the method should not be abandoned. New technical approaches can contribute to avoid complications. Method We performed a review of the literature with regard to conservative as well as endovascular treatment of ICAS. Different technical approaches are discussed and strategies to avoid complications are stressed. Based on the treatment indication, the positions of the authorities and the professional societies are taken into account. Results and Conclusion A single self-expanding stent is approved for the treatment of ICAS. Balloon mounted and other self-expanding Stents are available for off-label use. Anatomical conditions and features of the stenosis determine the choice of material. Distal wire perforations causing intracranial bleedings may occur during exchange manoeuvres and constitute one of the technical complications in the treatment of ICAS. In contrast, there is hardly any efficient way to eliminate the risk of ischemia in the territory of perforating arteries arising from the intracranial posterior circulation and the middle cerebral artery. The results of the randomized prospective trials strengthen the conservative treatment of ICAS. Endovascular treatment should not be withheld from patients with either hemodynamic stenosis, recurrent ischemic events under best medical treatment in the territory of the stenosed vessel or acute occlusions of a stenosis. Key Points: Citation Format

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

Cited by 46 publications

References 31 publications

Percutaneous transluminal angioplasty using the novel drug-coated balloon catheter SeQuent Please NEO for the treatment of symptomatic intracranial severe stenosis: feasibility and safety study

Percutaneous transluminal angioplasty using the novel drug-coated balloon catheter SeQuent Please NEO for the treatment of symptomatic intracranial severe stenosis: feasibility and safety study

Drug-coated balloons for the treatment of symptomatic intracranial atherosclerosis: initial experience and follow-up outcome

Endovascular Treatment of Intracranial Atherosclerotic Stenosis

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