Document Detail


Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial.
MedLine Citation:
PMID:  22932714     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Present mechanical devices are unable to achieve recanalisation in up to 20-40% of large vessel occlusion strokes. We compared efficacy and safety of the Trevo Retriever, a new stent-like device, with its US Food and Drug Administration-cleared predecessor, the Merci Retriever.
METHODS: In this open-label randomised controlled trial, we recruited patients at 26 sites in the USA and one in Spain. We included adults aged 18-85 years with angiographically confirmed large vessel occlusion strokes and US National Institutes of Health Stroke Scale (NIHSS) scores of 8-29 within 8 h of symptom onset. We randomly assigned patients (1:1) with sequentially numbered sealed envelopes to thrombectomy with Trevo or Merci devices. Randomisation was stratified by age (≤68 years vs 69-85 years) and NIHSS scores (≤18 vs 19-29) with alternating blocks of various sizes. The primary efficacy endpoint, assessed by an unmasked core laboratory, was thrombolysis in cerebral infarction (TICI) scores of 2 or greater reperfusion with the assigned device alone. The primary safety endpoint was a composite of procedure-related adverse events. Analyses were done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01270867.
FINDINGS: Between Feb 3, 2011, and Dec 1, 2011, we randomly assigned 88 patients to the Trevo Retriever group and 90 patients to Merci Retriever group. 76 (86%) patients in the Trevo group and 54 (60%) in the Merci group met the primary endpoint after the assigned device was used (odds ratio 4·22, 95% CI 1·92-9·69; p(superiority)<0·0001). Incidence of the primary safety endpoint did not differ between groups (13 [15%] patients in the Trevo group vs 21 [23%] in the Merci group; p=0·1826).
INTERPRETATION: Patients who have had large vessel occlusion strokes but are ineligible for (or refractory to) intravenous tissue plasminogen activator should be treated with the Trevo Retriever in preference to the Merci Retriever.
FUNDING: Stryker Neurovascular.
Authors:
Raul G Nogueira; Helmi L Lutsep; Rishi Gupta; Tudor G Jovin; Gregory W Albers; Gary A Walker; David S Liebeskind; Wade S Smith;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-08-26
Journal Detail:
Title:  Lancet     Volume:  380     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-08     Completed Date:  2012-10-15     Revised Date:  2014-10-15    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  1231-40     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 Elsevier Ltd. All rights reserved.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01270867
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Brain Ischemia / complications,  radiography,  surgery
Cerebral Angiography
Female
Humans
Male
Stroke / etiology,  radiography,  surgery*
Thrombectomy / adverse effects,  instrumentation*
Grant Support
ID/Acronym/Agency:
K24 NS072272/NS/NINDS NIH HHS
Investigator
Investigator/Affiliation:
H L Lutsep / ; R G Nogueira / ; W S Smith / ; G Albers / ; P Meyers / ; R Roberts / ; J English / ; A Flint / ; A Rai / ; D S Liebeskind / ; N Sanossian / ; C Jahans / ; P McMahon / ; K Valley / ; G Walker / ; R P Chiacchierini / ; B Xiang / ; N Akhtar / ; J Barr / ; B Baxter / ; M Berlet / ; P Blom / ; R Budzik / ; T Devlin / ; C Given / ; R Gupta / ; F Hellinger / ; T Jovin / ; E Levy / ; I Linfante / ; D Lopes / ; H Lutsep / ; J Macho / ; R Malek / ; M Mawad / ; P Ng / ; A Nohara / ; R Rosenwasser / ; N Rutledge / ; M Rymer / ; Q Shah / ; H Shownkeen / ; A Siddiqui / ; S Starkman / ; E Veznedaroglu / ; A Xavier / ; C Zylak /
Comments/Corrections
Comment In:
Nat Rev Neurol. 2012 Oct;8(10):531   [PMID:  22986434 ]
Lancet. 2012 Oct 6;380(9849):1208-10   [PMID:  22932712 ]
Radiologe. 2013 Jul;53(7):580-1   [PMID:  23719754 ]
Erratum In:
Lancet. 2012 Oct 6;380(9849):1230

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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