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01-08-2016 | Interventional Neuroradiology

GREAT—a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results

Authors: Christian A. Taschner, René Chapot, Vincent Costalat, Paolo Machi, Patrick Courthéoux, Xavier Barreau, Jérôme Berge, Laurent Pierot, Kryzsztof Kadziolka, Betty Jean, Raphaël Blanc, Alessandra Biondi, Hervé Brunel, Sophie Gallas, Ansgar Berlis, Denis Herbreteau, Joachim Berkefeld, Horst Urbach, Samer El Shikh, Jens Fiehler, Hubert Desal, Erika Graf, Alain Bonafé

Published in: Neuroradiology | Issue 8/2016

Abstract

Introduction

Hybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial.

Methods

Web-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up.

Results

Five hundred thirteen patients were randomized (hydrogel n = 256, bare platinum n = 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel n = 243, bare platinum n = 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel n = 28, bare platinum n = 30, p = 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively (p < 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate (p = 0.8).

Conclusion

Second-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils.

Trial registration

http://www.germanctr.de, DRKS00003132

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Title: GREAT—a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results
Authors: Christian A. Taschner
René Chapot
Vincent Costalat
Paolo Machi
Patrick Courthéoux
Xavier Barreau
Jérôme Berge
Laurent Pierot
Kryzsztof Kadziolka
Betty Jean
Raphaël Blanc
Alessandra Biondi
Hervé Brunel
Sophie Gallas
Ansgar Berlis
Denis Herbreteau
Joachim Berkefeld
Horst Urbach
Samer El Shikh
Jens Fiehler
Hubert Desal
Erika Graf
Alain Bonafé
Publication date: 01-08-2016
Publisher: Springer Berlin Heidelberg
Published in: Neuroradiology / Issue 8/2016
Print ISSN: 0028-3940
Electronic ISSN: 1432-1920
DOI: https://doi.org/10.1007/s00234-016-1693-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

GREAT—a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results

Abstract

Introduction

Methods

Results

Conclusion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusion

Trial registration

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