Enterprise Stent for the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis: an Initial Experience of 44 Patients

Background: Wingspan stenting for the treatment of complex intracranial atherosclerotic stenosis (ICAS), i.e., that involving tortuous vascular pathways, long (>15 mm) lesions or arterial bifurcations, has a relatively high risk of complications. This retrospective study assessed the safety and efficacy of undersized balloon angioplasty followed by deployment of the more flexible Enterprise stent for the treatment of complex symptomatic ICAS.

Methods: Forty-four patients on combined antiplatelet therapy and intensive risk factor management and a symptomatic 70-99% stenosis of a major intracranial artery in complex settings that was treated with balloon angioplasty and Enterprise stent deployment between July 2009 and August 2013 were enrolled. Primary outcome was occurrence of ischemic or hemorrhagic stroke or death within 30 days after intervention. Secondary outcomes included procedural success (defined as achievement of <50% immediate residual stenosis), and follow-up clinical and angiographic outcomes.

Results: With a procedural success rate of 100%, stenosis was reduced from 79.3 ± 8.1-14.9 ± 2.3%. Three (6.8%) ischemic and 1 (2.2%) hemorrhagic strokes occurred during the periprocedural period, with no further transient ischemic attacks or strokes in the 42 patients available at median 25.6 (range, 12-57) months follow-up. Of the 38 (86.4%) patients who underwent angiographic follow-up, 3 (6.81%) developed >50% in-stent restenosis after mean 22 months follow-up.

Conclusion: In this retrospective, single-center experience, undersized balloon angioplasty followed by Enterprise stent deployment appears technically feasible with a relatively low rate of complications for the treatment of complex symptomatic ICAS. Prospective, multicenter, randomized controlled trials against optimal medical management are warranted.