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

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.