The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis

• Authors: O. O. Zaidat, Froedert &Medical College of Wisconsin; R. Klucznik, Methodist Hospital Houston; M. J. Alexander, Duke University; J. Chaloupka, University of Iowa; H. Lutsep, Oregon Health and Science University; S. Barnwell, Oregon Health and Science University; M. Mawad, Baylor College of Medicine; B. Lane, Emory University; Michael Lynn, Emory University; M. Chimowitz, Emory University
• Journal Title: Neurology
• Volume: Volume 70, Number 17
• Publisher: American Academy of Neurology (AAN) | 2008-01-01, Pages 1518-1524
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1212/01.wnl.0000306308.08229.a3
• Subjects: Biology, Neuroscience; Health Sciences, Medicine and Surgery; Biology, Biostatistics
• Keywords: Aged; Constriction, Pathologic; Device Approval; Humans; Intracranial Arteriosclerosis; Kaplan-Meier Estimate; Male; Middle Aged; National Institutes of Health (U.S.); Randomized Controlled Trials as Topic; Registries; Risk Factors; Stents; Stroke; Treatment Outcome; United States

Abstract

BACKGROUND: The Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial showed that patients with symptomatic 70% to 99% intracranial arterial stenosis are at particularly high risk of ipsilateral stroke on medical therapy: 18% at 1 year (95% CI = 3% to 24%). The Wingspan intracranial stent is another therapeutic option but there are limited data on the technical success of stenting and outcome of patients with 70% to 99% stenosis treated with a Wingspan stent. METHODS: Sixteen medical centers enrolled consecutive patients treated with a Wingspan stent in this registry between November 2005 and October 2006. Data on stenting indication, severity of stenosis, technical success (stent placement across the target lesion with <50% residual stenosis), follow-up angiography, and outcome were collected. RESULTS: A total of 129 patients with symptomatic 70% to 99% intracranial stenosis were enrolled. The technical success rate was 96.7%. The mean pre and post-stent stenoses were 82% and 20%. The frequency of any stroke, intracerebral hemorrhage, or death within 30 days or ipsilateral stroke beyond 30 days was 14.0% at 6 months (95% CI = 8.7% to 22.1%). The frequency of ≥50% restenosis on follow-up angiography was 13/52 (25%). CONCLUSION: The use of a Wingspan stent in patients with severe intracranial stenosis is relatively safe with high rate of technical success with moderately high rate of restenosis. Comparison of the event rates in high-risk patients in Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) vs this registry do not rule out either that stenting could be associated with a substantial relative risk reduction (e.g., 50%) or has no advantage compared with medical therapy. A randomized trial comparing stenting with medical therapy is needed.