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From the Medical College of Wisconsin/Froedtert Hospital (O.O.Z.), Milwaukee; Methodist Hospital (R.K.), Houston, TX; Duke University (M.J.A.), Durham, NC; University of Iowa (J.C.), Iowa City; Oregon Health and Science University (H.L., S.B.), Portland; Baylor College of Medicine (M.M.), Houston, TX; and Emory University (B.L., M.J.L., M.C.), Atlanta, GA.
Address correspondence and reprint requests to Dr. Osama O. Zaidat, Associate Professor of Neurology and Neurosurgery, Medical College of Wisconsin/Froedtert Hospital, 9200 W Wisconsin Avenue, Milwaukee, WI 53226 szaidat{at}mcw.edu
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.
GLOSSARY: FDA = Food and Drug Administration; HDE = Humanitarian Device Exemption; ICH = intracerebral hemorrhage; WASID = Warfarin-Aspirin Symptomatic Intracranial Disease.
Received June 5, 2007. Accepted in final form November 5, 2007.
Editorial, page 1508
e-Pub ahead of print on January 30, 2008, at www.neurology.org.
*Investigators of the NIH Multi-center Wingspan Intracranial Stent Registry Study Group are listed in the appendix.
Funded by NIH/National Institute of Neurological Disorders and Stroke Grant R01 NS051688-01 to Dr. Marc Chimowitz.
Disclosure: O.O.Z., M.J.A., S.B., H.L., J.C., and M.M. consult for or have received an honorarium from Boston Scientific Inc., the manufacturers of the Wingspan stent.
Presented in the Late-Breaking Science Oral Abstracts, International Stroke Conference, San Francisco, CA, February 9, 2007.
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