Background: Fast recanalization has been shown to be one of the most important factors for good clinical outcome in stroke patients with acute large vessel occlusion. While intravenous thrombolysis has been shown to be of limited effect in patients with large clot burden, intra-arterial neurothrombectomy offers a new and promising possibility to achieve high recanalization rates within a short time. The Trevo device is a stent-like retriever and was primarily designed to remove thrombus in patients experiencing an acute ischemic stroke. We report on the results of the TREVO Study, which was a prospective, multicenter study in acute stroke patients treated with the Trevo device.
Methods: Patients were recruited in seven European centers under the control of an external monitor. Centers were selected because of their long experience with interventional stroke therapy especially with neurothrombectomy. We included adults aged 18-85 years with angiographically confirmed large vessel occlusion strokes and NIHSS scores of 8-30 and treatable within 8 h of symptom onset. The primary endpoint was revascularization, defined as at least TICI (thrombolysis in cerebral infarction) 2a. The revascularization scores were assessed by an independent core lab. Secondary endpoints were clinical outcome at 90 days (mRS 90), any device-related serious adverse events and the rate of symptomatic intracerebral hemorrhages.
Results: 60 patients were enrolled. The overall recanalization rate (≥TICI 2a) was 91.7% and TICI 2b and 3 was achieved in 78.3%. At 90 days, 55% of the patients had a favorable neurological outcome (mRS 0-2) and 20% had died. Patients with successful recanalization (TICI 2a,b/3) had a good 90-day neurological outcome (mRS 0-2) in 60%, whereas no patient without recanalization had a mRS 90 <3. The overall rate of symptomatic intracerebral hemorrhage according to the SITS-MOST criteria was 5% (3/60).
Conclusions: The study suggest that the Trevo Stentriever™ is a safe and effective device, which may offer the possibility of a high reperfusion rate and a high rate of patients with good clinical outcome after acute ischemic stroke due to proximal arterial occlusion. Randomized trials comparing intravenous thrombolysis with neurothrombectomy are now urgently needed to evaluate this new approach of interventional stroke therapy.
Copyright © 2013 S. Karger AG, Basel.