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Trevo Versus Merci Retrievers for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischaemic Stroke (TREVO 2): A Randomised Trial
Study Questions:
What is the efficacy and safety of the Trevo Retriever, a new stent-like device, compared with the Merci Retriever?
Methods:
In TREVO 2, an open-label randomized controlled trial, the investigators recruited patients at 26 sites in the United States and one in Spain. The investigators included adults ages 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 hours of symptom onset. They randomly assigned patients (1:1) with sequentially numbered sealed envelopes to thrombectomy with Trevo or Merci devices. Randomization 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.
Results:
Between February 3, 2011, and December 1, 2011, investigators randomly assigned 88 patients to the Trevo Retriever group and 90 patients to Merci Retriever group. A total of 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% confidence interval, 2.01-8.86; 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).
Conclusions:
The authors concluded that 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.
Perspective:
This study reports that the Trevo Retriever was superior to the Merci Retriever for arterial revascularization in terms of reperfusion to TICI 2 or greater in the setting of acute ischemic stroke. Notably, increased frequency and extent of reperfusion was associated with improved clinical outcomes at 24 hours, shorter hospital stays, and improved independence. However, definitive demonstration of benefit of mechanical thrombectomy with Trevo Retriever can only come from the undertaking of randomized trials to directly compare mechanical thrombectomy using Trevo Retriever with intravenous thrombolysis and to supportive medical care alone. Future studies will also need to compare the Trevo Retriever with the Solitaire Flow Restoration device.
Keywords: Stroke, Cerebral Infarction, Thrombectomy, Spain, National Institutes of Health (U.S.), Stents
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