Mechanical recanalization with flow restoration in acute ischemic stroke: the ReFlow (mechanical recanalization with flow restoration in acute ischemic stroke) study

Christian Roth, Wolfgang Reith, Silke Walter, Stefanie Behnke, Michael Kettner, Julio Viera, Umut Yilmaz, Maria Alexandrou, Maria Politi, Panagiotis Kostopoulos, Heiko Körner, Christoph Krick, Anton Haass, Klaus Fassbender, Panagiotis Papanagiotou, Christian Roth, Wolfgang Reith, Silke Walter, Stefanie Behnke, Michael Kettner, Julio Viera, Umut Yilmaz, Maria Alexandrou, Maria Politi, Panagiotis Kostopoulos, Heiko Körner, Christoph Krick, Anton Haass, Klaus Fassbender, Panagiotis Papanagiotou

Abstract

Objectives: This study sought to assess the feasibility and safety of a recently described technique of mechanical recanalization with the help of a stent-like device.

Background: In the special group of acute stroke patients with an intracranial large vessel occlusion, intravenous tissue-type plasminogen activator on its own leads to a good clinical outcome (mRS ≤ 2) in only 15% to 25% of cases. The aforementioned technique of mechanical recanalization showed very promising clinical results.

Methods: Forty patients presenting within 6 h from stroke symptom onset were enrolled. Mechanical recanalization was performed using a Solitaire FR revascularization device. The primary endpoint of the study was the clinical outcome rated with the help of the modified Rankin Scale (mRS) after 90 days.

Results: Twenty-four patients (60%) showed a good clinical outcome (mRS ≤ 2) at 90 days. One symptomatic hemorrhage was detected on follow-up computed tomography. The death rate was 12.5% (5 patients). Successful recanalization (Thrombolysis In Cerebral Infarction score ≥ 2b) of the target vessel was achieved in 95% of the patients with a mean of 1.8 runs with the device.

Conclusions: The ReFlow (Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke) study shows that mechanical recanalization with flow restoration is highly effective in stroke patients with a large intracranial vessel occlusion presenting within 4.5 h after symptom onset. (Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke [ReFlow]; NCT01210729).

Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Source: PubMed

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