Journal Article

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

Lutsep, Helmi L, Liebeskind, David S, Smith, Wade S, Albers, Gregory W, Gupta, Rishi, Jovin, Tudor G, Walker, Gary A, Nogueira, Raul G

2012

نظرة عامة

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. 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. 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; psuperiority<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). 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. Stryker Neurovascular.

• الناشر: Elsevier Ltd,Elsevier,Elsevier Limited
• موضوع: adults / Aged / Aged, 80 and over / Biological and medical sciences / Blood pressure / Brain Ischemia - complications / Brain Ischemia - diagnostic imaging / Brain Ischemia - surgery / Cerebral Angiography / Clinical trials / Female / General aspects / Humans / infarction / Internal Medicine / intravenous injection / Male / Medical imaging / Medical sciences / National Institutes of Health / Neurology / odds ratio / patients / randomized clinical trials / Regulatory approval / Safety / Spain / Stents / Stroke / Stroke - diagnostic imaging / Stroke - etiology / Stroke - surgery / t-plasminogen activator / Thrombectomy - adverse effects / Thrombectomy - instrumentation / United States / Vascular diseases and vascular malformations of the nervous system / Veins & arteries