Safety and efficacy of stent retrievers plus contact aspiration in patients with acute ischaemic anterior circulation stroke and positive susceptibility vessel sign in France (VECTOR): a randomised, single-blind trial.


Journal

The Lancet. Neurology
ISSN: 1474-4465
Titre abrégé: Lancet Neurol
Pays: England
ID NLM: 101139309

Informations de publication

Date de publication:
Jul 2024
Historique:
received: 17 02 2024
revised: 03 04 2024
accepted: 08 04 2024
medline: 15 6 2024
pubmed: 15 6 2024
entrez: 14 6 2024
Statut: ppublish

Résumé

Positive susceptibility vessel sign (SVS) in patients with acute ischaemic stroke has been associated with friable red blood cell-rich clots and more effective recanalisation using stent retrievers versus contact aspiration. We compared the safety and efficacy of stent retrievers plus contact aspiration (combined technique) versus contact aspiration alone as the first-line thrombectomy technique in patients with acute ischaemic anterior circulation stroke and SVS-positive occlusions. Adaptive Endovascular Strategy to the Clot MRI in Large Intracranial Vessel Occlusion (VECTOR) was a prospective, randomised, open-label study with blinded evaluation. Patients with SVS-positive anterior circulation occlusions on pretreatment MRI and arterial puncture within 24 h of symptom onset were enrolled from 22 centres in France. A centralised web-based method was used by interventional neuroradiologists for dynamic randomisation by minimisation. Patients were randomly assigned 1:1 to the combined technique or contact aspiration alone. The primary outcome was expanded Thrombolysis in Cerebral Infarction (eTICI) grade 2c or 3 reperfusion after three or fewer passes on post-treatment angiogram, adjudicated by a blinded independent central imaging core laboratory. The intention-to-treat population was used to assess the primary and secondary outcomes. This trial is registered with ClinicalTrials.gov (NCT04139486) and is complete. Between Nov 26, 2019, and Feb 14, 2022, 526 patients were enrolled, of whom 521 constituted the intention-to-treat population (combined technique, n=263; contact aspiration alone, n=258). The median age of participants was 74·9 years (IQR 64·4-83·3); 284 (55%) were female and 237 (45%) male. The primary outcome did not differ significantly between groups (152 [58%] of 263 patients for the combined technique vs 135 [52%] of 258 for contact aspiration; odds ratio [OR] 1·27; 95% CI 0·88-1·83; p=0·19). Procedure-related adverse events occurred in 32 (12%) of 263 patients in the combined technique group and 27 (11%) of 257 in the contact aspiration group (OR 1·14; 0·65-2·00; p=0·65). The most common adverse event was intracerebral haemorrhage (146 [56%] of 259 patients for the combined technique vs 123 [49%] of 251 for contact aspiration; OR 1·32; 0·91-1·90; p=0·13). All-cause mortality at 3 months occurred in 57 (23%) of 251 patients in the combined technique group and 48 (19%) of 247 in the contact aspiration group (OR 1·19; 0·76-1·86; p=0·45), none of which was treatment-related. The results of the VECTOR trial do not show superiority of the combined stent retriever plus contact aspiration technique over contact aspiration alone in patients with SVS-positive occlusion with respect to achieving eTICI 2c-3 within three passes. These findings support the use of either the combined technique or contact aspiration alone as the initial thrombectomy strategy in patients with acute anterior circulation stroke with SVS on pretreatment MRI. Cerenovus.

Sections du résumé

BACKGROUND BACKGROUND
Positive susceptibility vessel sign (SVS) in patients with acute ischaemic stroke has been associated with friable red blood cell-rich clots and more effective recanalisation using stent retrievers versus contact aspiration. We compared the safety and efficacy of stent retrievers plus contact aspiration (combined technique) versus contact aspiration alone as the first-line thrombectomy technique in patients with acute ischaemic anterior circulation stroke and SVS-positive occlusions.
METHODS METHODS
Adaptive Endovascular Strategy to the Clot MRI in Large Intracranial Vessel Occlusion (VECTOR) was a prospective, randomised, open-label study with blinded evaluation. Patients with SVS-positive anterior circulation occlusions on pretreatment MRI and arterial puncture within 24 h of symptom onset were enrolled from 22 centres in France. A centralised web-based method was used by interventional neuroradiologists for dynamic randomisation by minimisation. Patients were randomly assigned 1:1 to the combined technique or contact aspiration alone. The primary outcome was expanded Thrombolysis in Cerebral Infarction (eTICI) grade 2c or 3 reperfusion after three or fewer passes on post-treatment angiogram, adjudicated by a blinded independent central imaging core laboratory. The intention-to-treat population was used to assess the primary and secondary outcomes. This trial is registered with ClinicalTrials.gov (NCT04139486) and is complete.
FINDINGS RESULTS
Between Nov 26, 2019, and Feb 14, 2022, 526 patients were enrolled, of whom 521 constituted the intention-to-treat population (combined technique, n=263; contact aspiration alone, n=258). The median age of participants was 74·9 years (IQR 64·4-83·3); 284 (55%) were female and 237 (45%) male. The primary outcome did not differ significantly between groups (152 [58%] of 263 patients for the combined technique vs 135 [52%] of 258 for contact aspiration; odds ratio [OR] 1·27; 95% CI 0·88-1·83; p=0·19). Procedure-related adverse events occurred in 32 (12%) of 263 patients in the combined technique group and 27 (11%) of 257 in the contact aspiration group (OR 1·14; 0·65-2·00; p=0·65). The most common adverse event was intracerebral haemorrhage (146 [56%] of 259 patients for the combined technique vs 123 [49%] of 251 for contact aspiration; OR 1·32; 0·91-1·90; p=0·13). All-cause mortality at 3 months occurred in 57 (23%) of 251 patients in the combined technique group and 48 (19%) of 247 in the contact aspiration group (OR 1·19; 0·76-1·86; p=0·45), none of which was treatment-related.
INTERPRETATION CONCLUSIONS
The results of the VECTOR trial do not show superiority of the combined stent retriever plus contact aspiration technique over contact aspiration alone in patients with SVS-positive occlusion with respect to achieving eTICI 2c-3 within three passes. These findings support the use of either the combined technique or contact aspiration alone as the initial thrombectomy strategy in patients with acute anterior circulation stroke with SVS on pretreatment MRI.
FUNDING BACKGROUND
Cerenovus.

Identifiants

pubmed: 38876748
pii: S1474-4422(24)00165-0
doi: 10.1016/S1474-4422(24)00165-0
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT04139486']

Types de publication

Journal Article Randomized Controlled Trial Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

700-711

Investigateurs

Wagih Benhassen (W)
Olivier Naggara (O)
Célia Tuttle (C)
Louis Veunac (L)
Alain Duhamel (A)
Roberto Riva (R)
Lili Détraz (L)
Simon Escalard (S)
Lorenzo Piergallini (L)
Hocine Redjem (H)
Anthony Reyre (A)
Vanessa Chalumeau (V)
Nicolas Pangon (N)
Thomas Personnic (T)
Grègoire Boulouis (G)
Xavier Carle (X)
Solène Hebert (S)
Alexis Gonnet (A)
Cedric Lenoble (C)
Benjamin Maïer (B)
Helene Raoult (H)
Laurent Lagoarde-Segot (L)
Frederico Di Maria (F)
Pierre-Louis Alexandre (PL)
Matteo Cappucci (M)
Benjamin Gory (B)
Florent Gariel (F)
Christophe Paya (C)
Fouzi Bala (F)
Martin Bretzner (M)
Géraud Forestier (G)
Pierre François Manceau (PF)
Quentin Alias (Q)
Jean Baptiste Girot (JB)
Imad Derraz (I)
Julien Ognard (J)

Informations de copyright

Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

Déclaration de conflit d'intérêts

Declaration of interests RB reports paid lectures for Microvention, Medtronic, Penumbra, and Johnson & Johnson (Cerenovus). GM reports consulting for Balt, Microvention Europe, and Stryker Neurovascular; and paid lectures for Phenox, Medtronic, Johnson & Johnson (Cerenovus), and Bracco. KJ reports consulting for Balt. J-CG reports consulting for Balt, Stryker, Phenox, and Medtronic. FC reports consulting for Medtronic, Balt Extrusion, Penumbra, Microvention, and Stryker; being a board member of Artedrone; and having stock options with Intradys and Letsgetproof. XB reports consulting for Stryker and Microvention. SS reports consulting for Phillips Healthcare; support for attending meetings and travel from Cerenovus, Microvention, and Balt; and paid lectures for EISAI. JSR reports paid lectures for Medtronic and Johnson & Johnson (Cerenovus). All other authors declare no competing interests.

Auteurs

Romain Bourcier (R)

Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nantes, Thorax Institute, Nantes, France. Electronic address: romain.bourcier@chu-nantes.fr.

Gaultier Marnat (G)

Department of Neuroradiology, University Hospital of Bordeaux, Bordeaux, France.

Cyril Dargazanli (C)

Institut de Génomique Fonctionnelle, Université de Montpellier, Montpellier, France.

François Zhu (F)

Department of Diagnostic and Interventional Neuroradiology, University Hospital of Nancy, Nancy, France.

Arturo Consoli (A)

Diagnostic and Interventional Neuroradiology, Foch Hospital, Suresnes, University of Versailles Saint-Quentin-des-Yvelines, Versailles, France.

Eimad Shotar (E)

Department of Neuroradiology, La Pitie Salpetrière Hospital, Paris, France.

Kevin Premat (K)

Department of Neuroradiology, La Pitie Salpetrière Hospital, Paris, France.

François Eugene (F)

Department of Medical Imaging, University Hospital of Rennes, Rennes, France.

Kevin Janot (K)

Department of Neuroradiology, University Hospital of Tours, Tours, France.

Vincent L'Allinec (V)

Department of Radiology, University Hospital of Angers, Angers, France.

Julien Ognard (J)

Brest University Hospital, Radiology Department, GETBO Research Unit, Brest, France.

Jean-Philippe Desilles (JP)

Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France.

Raphael Blanc (R)

Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France.

Jean-Christophe Gentric (JC)

Brest University Hospital, Radiology Department, GETBO Research Unit, Brest, France.

Frédéric Bourdain (F)

Department of Neurology, Regional Hospital of Bayonne, Bayonne, France.

Julien Labreuche (J)

Department of Biostatistics, University Hospital of Lille, Lille, France.

Liang Liao (L)

Department of Diagnostic and Interventional Neuroradiology, University Hospital of Nancy, Nancy, France.

Frédéric Clarençon (F)

Department of Neuroradiology, La Pitie Salpetrière Hospital, Paris, France.

Xavier Barreau (X)

Department of Neuroradiology, University Hospital of Bordeaux, Bordeaux, France.

Héloïse Ifergan (H)

Department of Neuroradiology, University Hospital of Tours, Tours, France.

Jean-François Hak (JF)

Department of Neuroradiology, University Hospital of Marseille, Marseille, France.

Basile Kerleroux (B)

Department of Neuroradiology, University Hospital of Marseille, Marseille, France.

Raoul Pop (R)

Interventional Neuroradiology Department, Strasbourg University Hospitals, Strasbourg, France.

Sébastien Soize (S)

Department of Neuroradiology, University Hospital of Reims, Reims, France.

Nicolas Bricout (N)

Interventional Neuroradiology, Hospital Center University of Lille, Lille, France.

Jildaz Caroff (J)

Department of Neuroradiology, Bicêtre Hospital, Paris Saclay University, Le Kremlin-Bicêtre, Île-de-France, France.

Johann Sebastian Richter (JS)

Department of Radiology, Hospital Center of Pau, Pau, France.

Hubert Desal (H)

Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nantes, Thorax Institute, Nantes, France.

Bertrand Lapergue (B)

Department of Neuroradiology and Stroke Unit, Foch Hospital, Suresnes, France, University of Versailles Saint-Quentin-des-Yvelines, Versailles, France.

Aymeric Rouchaud (A)

Department of Interventional Neuroradiology, Limoges University Hospital, Limoges, France.

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