Primary Stenting for Acute Ischemic Stroke Using the Enterprise Intracranial Stent: 2-Year Results of a Phase-I Trial.

ABSTRACT

BACKGROUND: The preliminary results of a prospective consecutive series of 20 patients who underwent Enterprise-assisted recanalization for acute ischemic stroke were recently reported. Recanalization to thrombolysis in myocardial infarction (TIMI) grade 2 (n = 6) or 3 (n = 12) flow was achieved in 18 patients (90% revascularization rate). Good outcome (modified Rankin Scale [mRS] score of ≤2) was obtained in 10 patients (50%) at 30 days. Here, we report the 2-year clinical follow-up data for patients enrolled in that prospective study. METHODS: Study patients were scheduled for examinations 2 years postprocedure at which time mRS and Barthel indices were obtained. RESULTS: Among 12 survivors at 2 years, 11 of the 20 (55%) study patients improved to mRS score ≤2 and 1 (5%) patient was disabled with an mRS 4. Of the 11 patients with mRS 0-2 scores, 10 patients had a Barthel index of 100, and the 11th had a Barthel index of 95. One patient improved from mRS 3 to 2 during the interval between the 6- and 12-month postintervention evaluations after intervention. Eight of 13 (62%) survivors underwent follow-up imaging at 6 months without evidence of instent stenosis or thrombosis. CONCLUSION: At 2 years of follow-up, improvement in quality of life after acute stroke intervention was sustained; and 11 of 12 (92%) survivors had an excellent functional outcome. Improvement in functional status can occur even up to 1 year after stroke intervention. These results 2 years after acute stroke intervention demonstrate sustained benefit from acute intervention. ABBREVIATIONS AISacute ischemic strokeCTcomputed tomographicFDAFood and Drug AdministrationIVintravenousMCAmiddle cerebral arterymRSmodified Rankin ScaleNIHSSNational Institutes of Health Stroke Scale ScoreSWIFTSolitaire FR With the Intention For Thrombectomy (SWIFT)TIMIthrombolysis in myocardial infarctiontPAtissue plasminogen activatorTREVOThrombectomy REvascularization of large Vessel Occlusions.