Original title: Mechanical Recanalization with Flow Restoration in Acute Ischemic Stroke. The Mechanical Recanalization with Flow Restoration in Acute Ischemic Stroke (ReFlow) Study. Reference: Christian Roth et al. J Am Coll Cardiol Intv 2013. Article in press.
The intravenous tissue-type plasminogen activator (tPA) has proved to reduce morbidity and mortality in patients with acute ischemic stroke. In the sub group of acute stroke patients with an intracranial large vessel occlusion, thrombolysis has favorable results (modified Rankin scale ≤2) only in 15 to 25% of cases. These patients could benefit from an additional mechanical like procedure; however there is no evidence to support this.
The recently described mechanical recanalization with the help of a stent-like device has promising results both technical and clinical, and this prospective study sought to assess the feasibility and safety of the described technique. Eligible patients were those admitted within 6 hours of stroke symptom onset with a >10 NIHSS (National Institutes of Health Stroke Scale) and an angiotomography to discard hemorrhage and prove a larger intracranial vessel occlusion. Within a 4.5 hr window, tPA was indicated and patient was sent to catheterization. The primary endpoint of the study was the clinical outcome rated with the modified Rankin Scale after 90 days, considering a ≤2 score as good clinical outcome.
Safety end point was intracranial hemorrhage complicating neurological status to 4 points in the NIHSS scale and all cause mortality. Between 2010 and 2011, forty patients presenting within 6 h from stroke symptom onset were enrolled. Mechanical recanalization was performed using a Solitaire FR revascularization device (ev3, Irvine, California). 80% were admitted within 3 hrs of symptom onset and the remaining 20% within 4.5 hours. At 90 days, 60% presented a modified Rankin score of ≤2. Hemorrhage transformation was observed in 4 patients but only one 80% were admitted within 3 hrs of symptom onset and the remaining 20% within 4.5 hours. At 90 days, 60% presented a modified Rankin score of ≤2. Hemorrhage transformation was observed in 4 patients but only one associated with a 4 point complication in the NIHSS scale was considered symptomatic,. All cause death rate was 12.5%. Successful recanalization of the target vessel was achieved in 95% of the patients.
Conclusion:
The ReFlow 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. A randomized study is required to compare this device associated with tPA vs. tPA alone.
Editorial Comment:
There is plenty of information on the endovascular treatment of acute ischemic stroke and, in general, outcomes have been neutral. In this work, very good outcomes were observed; however, the absence of a control group hinders a deeper analysis. The swift treatment (80% within 3 hs and all within 4.5 hs) is a limitation that reduces external validation; on the other hand, it shows us that it is possible to be within the time guideline recommendations when there is a trained team to manage stroke.
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