Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial

• Type of Material: Article
• Authors: Raul Nogueira, Emory University; Helmi L Lutsep, Oregon Health and Science University; Rishi Gupta, Emory University; Tudor G Jovin, University of Pittsburgh; Gregory W Albers, Stanford University; Gary A Walker, Stryker Neurovascular; David S Liebeskind, University of California Los Angeles; Wade S Smith, University of California San Francisco
• Language: English
• Date: 2012-10-06
• Publisher: Elsevier: Lancet
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2012 Elsevier Ltd. All rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.1016/S0140-6736(12)61299-9
• Title of Journal or Parent Work: Lancet
• ISSN: 0140-6736
• Volume: 380
• Issue: 9849
• Start Page: 1231
• End Page: 1240
• Grant/Funding Information: Stryker Neurovascular.
• Keywords: THROMBOLYSIS; Medicine, General & Internal; DEVICES; Science & Technology; EFFICACY; RT-PA STROKE; RECANALIZATION; TISSUE-PLASMINOGEN ACTIVATOR; DISEASE; Life Sciences & Biomedicine; General & Internal Medicine; SAFETY
• Research Categories: Health Sciences, Epidemiology; Health Sciences, Medicine and Surgery; Biology, Neuroscience

Abstract

Background: Present mechanical devices are unable to achieve recanalisation in up to 20-40% of large vessel occlusion strokes. We compared effi cacy 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. 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.