Summary 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; 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). 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.
Introduction The efficacy and safety of endovascular thrombectomy (EVT) beyond 6 hours from acute ischaemic stroke (AIS) onset for patients with proximal large vessel occlusion (LVO) selected without ...CT perfusion or MR imaging is undetermined in routine clinical practice. Methods In this single centre study, we identified consecutive AIS patients with an ICA or M1 MCA segment occlusion who were eligible for EVT based on non‐contrast CT/CT angiography (without CT perfusion or MR imaging) using an Alberta Stroke Program Early CT Score (ASPECTS) of ≥ 6, and an NIHSS score of≥ 6, presenting beyond 6 hours from stroke onset, between January 2018 and March 2022. During the study period, EVT capacity limitations meant EVT‐eligible patients presenting out of regular working hours (between 18.00 and 08.00 on weekdays) or on weekends, consistently received best medical management (BMM). This systemic unavailability of EVT, allows a comparison of EVT and BMM in patients who meet the same inclusion criteria, in which selection based on physician‐related bias is significantly reduced. Functional outcomes (modified Rankin Scale (mRS) at 90 days), symptomatic intracranial haemorrhage (sICH) and mortality at 90 days were compared between patients receiving EVT or BMM following multivariable adjustment for age, sex, baseline stroke severity, ASPECTS, onset‐to‐neuroimaging time, IV thrombolysis, and clot location.Pre‐specified subgroup analyses were performed. Results Among 4802 AIS patients, 150 patients (3.1%) presenting beyond 6‐hours of onset were eligible for EVT: 74 (49%) treated with EVT and 76 (51%) with BMM. Compared to the BMM group, patients treated with EVT had significantly improved functional outcome (mRS) (adjusted common OR = 2.23, 95%CI 1.18‐4.22, p = 0.013), and higher rates of functional independence (mRS≤2; 39.2.% vs 9.2%; aOR = 4.73, 95%CI 1.64‐13.63, p = 0.004). No significant difference was observed between the EVT and BMM groups in the sICH (5.4% vs 2.6%, p = 0.94) or mortality (20.2% vs 47.3%, p = 0.16) rates, respectively. EVT remained effective within the 6–12 hour and >12 hour time window subgroups. No significant treatment interaction was observed in all subgroups. Conclusions In routine clinical practice, of the 3.1% of patients in our AIS population presenting after 6 hours from stroke onset who were deemed eligible for EVT by NCCT/CTA alone, those treated with EVT achieved significantly improved functional outcome, compared to patients treated with BMM only. No significant differences were noted between the two groups with respect to sICH and mortality. While confirmatory randomised trials are awaited, these findings suggest that EVT is effective and safe when performed in AIS patients selected without CTP or MRI beyond 6 hours from stroke onset.
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