Abstract
Background: Solitaire flow restoration device have showed advantages in comparison with Merci device that is most used in endovascular therapy trials. We compared the effectiveness and safety of the additional Solitaire treatment and intravenous t-PA alone for stroke patients. Subjects and Methods: Consecutive patients with proximal intracranial occlusion who received intra-arterial reperfusion procedures by mechanical recanalization retrievable self-expanding stent (Solitaire group) after IV t-PA were studied. They were compared with patients from our prospective IV t-PA database with middle cerebral artery or basilar artery occlusion (IV group). Arterial occlusions were assessed with computed tomography angiography before IV t-PA treatment. Patients in Solitaire group underwent angiography as soon as possible after IV t-PA, and those with a vascular occlusion received endovascular intervention with Solitaire FR revascularization device. Clinical evaluation was assessed by National Institutes of Health Stroke Scale at baseline, 24 hours, and at discharge. Symptomatic intracranial hemorrhage was defined according to the National Institute of Neurological Disorders and Stroke trial. Functional evaluation was determined by modified Rankin Scale, with functional independence defined by modified Rankin Scale score of 2 at 3 months. Results: Thirty patients in the Solitaire group were compared with 74 patients in the IV group. The mean age was 59.7±12.5 years. 46 patients (44.2%) were women, and baseline median National Institutes of Health Stroke Scale score was 17 (interquartile range, 6). Mean time from symptoms to IV tPA was 151.4±47.9 minutes. More patients had good 3-month neurological outcome with Solitaire than with IV alone (56.7% vs 35.1%, p=0.04). Symptomatic intracranial hemorrhage was similar (Solitaire 6.7% versus IV 5.4%, P =1). Mortality at 3 months was 13.3% in the Solitaire group and 20.3% in the IV group (p=0.57). Conclusions: In this non-randomized study, compared with intravenous t-PA alone, additional Solitaire treatment was associated with better clinical outcome in in stroke patients with proximal intracranial occlusion.
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