The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis.
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 >or=50% restenosis on follow-up angiography was 13/52 (25%).


CONCLUSIONS
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.
Zaidat
O O
OO
Associate Medical College of Wisconsin/Froedtert Hospital, 9200 W Wisconsin Avenue, Milwaukee, WI 53226, USA. szaidat@mcw.edu
Klucznik
R
R
Alexander
M J
MJ
Chaloupka
J
J
Lutsep
H
H
Barnwell
S
S
Mawad
M
M
Lane
B
B
Lynn
M J
MJ
Chimowitz
M
M
D000368:Aged; D003251:Constriction, Pathologic / Q000473:pathology / Q000601:surgery*; D018795:Device Approval; D006801:Humans; D002537:Intracranial Arteriosclerosis / Q000473:pathology / Q000601:surgery; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009316:National Institutes of Health (U.S.); D016032:Randomized Controlled Trials as Topic; D012042:Registries; D012307:Risk Factors; D015607:Stents / Q000009:adverse effects / Q000706:statistics & numerical data; D020521:Stroke / Q000209:etiology; D016896:Treatment Outcome; D014481:United States