Published online before print January 30, 2008, doi:10.1212/01.wnl.0000306308.08229.a3)
NEUROLOGY 2008;70:1518-1524
© 2008 American Academy of Neurology
The NIH registry on use of the Wingspan stent for symptomatic70–99% intracranial arterial stenosis
O. O. Zaidat, MD, MS,
R. Klucznik, MD,
M. J. Alexander, MD, FACS,
J. Chaloupka, MD,
H. Lutsep, MD,
S. Barnwell, MD,
M. Mawad, MD,
B. Lane, BSN, RN,
M. J. Lynn, MS,
M. Chimowitz, MD For the NIH Multi-center Wingspan Intracranial Stent Registry Study Group*
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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Correspondence:
Read all Correspondence
- The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis
- Thomas W. Leung, et al.
- Neurology Online, 27 Mar 2008
[Full text]
- Reply from the authors
- Osama O Zaidat, et al.
- Neurology Online, 27 Mar 2008
[Full text]
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