Peri-procedural brain lesions prevention in CAS (3PCAS): Randomized trial comparing CGuard™ stent vs. Wallstent™.


Journal

International journal of cardiology
ISSN: 1874-1754
Titre abrégé: Int J Cardiol
Pays: Netherlands
ID NLM: 8200291

Informations de publication

Date de publication:
15 Mar 2019
Historique:
received: 30 03 2018
revised: 17 08 2018
accepted: 19 09 2018
pubmed: 30 9 2018
medline: 18 12 2019
entrez: 30 9 2018
Statut: ppublish

Résumé

Aim of this study was to evaluate peri-procedural incidence of new diffusion-weighted-magnetic-resonance-imaging (DWMRI) brain lesions in CAS patients treated by carotid mesh stent (CGuard™) or closed-cell stent (Wallstent™). Consecutive patients with asymptomatic carotid stenosis ≥ 70% were submitted to preoperative DW-MRI scan, to exclude the presence of preoperative silent cerebral lesions. Patients were randomized to CGuard or Wallstent. DWMRI was performed immediately after the intervention and at 72-hour postoperatively. Moreover, pre and postoperative Mini-Mental-State-Examination Test (MMSE) and a Montreal-Cognitive-Assessment (MoCA) test were conducted, and S100β and NSE neurobiomarkers were measured at 5-time points (preoperatively, 2, 12, 24, and 48 h postoperatively). From January 2015 to October 2016, sixty-one consecutive eligible patients were submitted to preoperative DWMRI scan. Three patients were excluded because of preoperative silent cerebral lesions. In 29 CGuard patients, 1 developed a minor stroke and 8 silent new lesions were observed in the 72 h-DWMRI (31%): 4 lesions were ipsilateral, and 4 lesions were contra or bilateral. In 29 Wallstent patients, 7 clinically-silent new lesions were found in the 72 h-DWMRI (24.1%; p = 0.38). In 4 cases lesions were ipsilateral and in 3 cases contra or bilateral. S100B values doubled at 48 h in 24 patients, and among them 12 presented new DWMRI lesions. 48-h S100B increase was significantly related to 72-h DWMRI lesions (p = 0.012). In our experience both stents showed an acceptable rate of subclinical neurological events with no significant differences at 72-hour DWMRI between groups. Bilateral/contralateral lesions suggest that periprocedural neurological damage may have extra-carotid sources.

Sections du résumé

BACKGROUND BACKGROUND
Aim of this study was to evaluate peri-procedural incidence of new diffusion-weighted-magnetic-resonance-imaging (DWMRI) brain lesions in CAS patients treated by carotid mesh stent (CGuard™) or closed-cell stent (Wallstent™).
METHODS METHODS
Consecutive patients with asymptomatic carotid stenosis ≥ 70% were submitted to preoperative DW-MRI scan, to exclude the presence of preoperative silent cerebral lesions. Patients were randomized to CGuard or Wallstent. DWMRI was performed immediately after the intervention and at 72-hour postoperatively. Moreover, pre and postoperative Mini-Mental-State-Examination Test (MMSE) and a Montreal-Cognitive-Assessment (MoCA) test were conducted, and S100β and NSE neurobiomarkers were measured at 5-time points (preoperatively, 2, 12, 24, and 48 h postoperatively).
RESULTS RESULTS
From January 2015 to October 2016, sixty-one consecutive eligible patients were submitted to preoperative DWMRI scan. Three patients were excluded because of preoperative silent cerebral lesions. In 29 CGuard patients, 1 developed a minor stroke and 8 silent new lesions were observed in the 72 h-DWMRI (31%): 4 lesions were ipsilateral, and 4 lesions were contra or bilateral. In 29 Wallstent patients, 7 clinically-silent new lesions were found in the 72 h-DWMRI (24.1%; p = 0.38). In 4 cases lesions were ipsilateral and in 3 cases contra or bilateral. S100B values doubled at 48 h in 24 patients, and among them 12 presented new DWMRI lesions. 48-h S100B increase was significantly related to 72-h DWMRI lesions (p = 0.012).
CONCLUSIONS CONCLUSIONS
In our experience both stents showed an acceptable rate of subclinical neurological events with no significant differences at 72-hour DWMRI between groups. Bilateral/contralateral lesions suggest that periprocedural neurological damage may have extra-carotid sources.

Identifiants

pubmed: 30266356
pii: S0167-5273(18)32131-4
doi: 10.1016/j.ijcard.2018.09.066
pii:
doi:

Types de publication

Comparative Study Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

148-153

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Auteurs

Laura Capoccia (L)

Vascular and Endovascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "La Sapienza" University of Rome, 155 Viale del Policlinico, 00161 Rome, Italy. Electronic address: laura.capoccia@uniroma1.it.

Pasqualino Sirignano (P)

Vascular and Endovascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "La Sapienza" University of Rome, 155 Viale del Policlinico, 00161 Rome, Italy. Electronic address: pasqualino.sirignano@uniroma1.it.

Wassim Mansour (W)

Vascular and Endovascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "La Sapienza" University of Rome, 155 Viale del Policlinico, 00161 Rome, Italy.

Alessandro d'Adamo (A)

Vascular and Endovascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "La Sapienza" University of Rome, 155 Viale del Policlinico, 00161 Rome, Italy.

Enrico Sbarigia (E)

Vascular and Endovascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "La Sapienza" University of Rome, 155 Viale del Policlinico, 00161 Rome, Italy. Electronic address: enrico.sbarigia@uniroma1.it.

Paola Mariani (P)

Clinical Pathology Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "La Sapienza" University of Rome, 155 Viale del Policlinico, 00161 Rome, Italy. Electronic address: paola.mariani@uniroma1.it.

Claudio Di Biasi (C)

Department of Radiology, Policlinico Umberto I, "La Sapienza" University of Rome, 155 Viale del Policlinico, 00161 Rome, Italy. Electronic address: claudio.dibiasi@uniroma1.it.

Francesco Speziale (F)

Vascular and Endovascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "La Sapienza" University of Rome, 155 Viale del Policlinico, 00161 Rome, Italy. Electronic address: francesco.speziale@uniroma1.it.

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Classifications MeSH