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

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).

• Authors: 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
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 6 Issue 4 Pg. 386-91 (Apr 2013) ISSN: 1876-7605 [Electronic] United States
• PMID: 23523460 (Publication Type: Clinical Trial, Journal Article)
• Copyright: Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Topics

• Aged
• Aged, 80 and over
• Brain Ischemia (diagnosis, mortality, physiopathology, therapy)
• Cerebrovascular Circulation
• Disability Evaluation
• Feasibility Studies
• Female
• Germany
• Humans
• Male
• Mechanical Thrombolysis (adverse effects, instrumentation, mortality)
• Middle Aged
• Predictive Value of Tests
• Prospective Studies
• Prosthesis Design
• Recovery of Function
• Stents
• Stroke (diagnosis, mortality, physiopathology, therapy)
• Time Factors
• Tomography, X-Ray Computed
• Treatment Outcome