The NIH registry on use of the Wingspan stent for symptomatic70–99% intracranial arterial stenosis
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.
GLOSSARY: FDA = Food and Drug Administration; HDE = Humanitarian Device Exemption; ICH = intracerebral hemorrhage; WASID = Warfarin-Aspirin Symptomatic Intracranial Disease.
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Published online: January 30, 2008
Published in print: April 22, 2008
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We read with interest that a relatively high rate of in-stent restenosis (ISR) (25%) was revealed in the NIH Wingspan registry. [1] This figure may not be an overestimate.
In our cohort of 40 patients with self-expandable stenting for symptomatic intracranial stenosis, 19 had repeat digital subtraction angiography (DSA) in 12 months. ISR (>50% stenosis) developed in five patients (26.3%) which was apparently independent of cardiovascular risk factor control. ISR may be more frequent in daily practice than the rate in the Wingspan phase I study. [2]
Although most patients with ISR remain asymptomatic, neo-intimal hyperplasia in intracranial vasculature may not be as benign as the authors suggested. [1] In a coronary model, ISR may cause branch occlusion and symptom recurrence. [3] In cerebral circulation, neo-intimal proliferation may similarly occlude perforators arising from middle cerebral artery (MCA) or basilar artery (BA) and cause infarction in the perforator territory where collateral is minimal. Furthermore, given the small luminal diameter of intracranial vessels, ISR predisposes to perfusion failure apart from thrombo-embolic risk. ISR could be an important factor governing the long-term outcome after intracranial stenting.
A randomized trial is warranted to investigate the efficacy of stenting in symptomatic intracranial stenosis, and it is encouraging to know that one is currently planned in the US. [1] In a country where intracranial stenosis is particularly prevalent, we have been conducting a pilot, randomized study comparing optimal medical treatment vs early adjunctive self-expandable stenting in patients with high risk of recurrence (i.e., recent cerebral ischemic event attributed to a high-grade (>70%) intracranial stenosis). Some issues encountered during the planning of our study may warrant discussion.
First, we randomized patients based on digital subtraction angiography (DSA) rather than CT angiography (CTA). CTA is invaluable for screening, but is insufficient to accurately quantify the severity of stenosis. In a few patients who had initially consented to the study, subtle vascular anomalies adjacent to the stenosis (like fenestrated MCA or BA) could only be revealed in three-dimensional reconstruction of DSA but not in CTA. Catastrophic complications may have occurred if CTA alone was relied upon.
Secondly, although double anti-platelet regimen has not been shown to be more effective than single anti-platelet treatment in symptomatic intracranial stenosis, combination therapy has been shown to decrease microembolic signal in symptomatic carotid stenosis. [4] To avoid this potential confounder, patients in both stenting and medical groups are offered dual anti-platelets.
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4. Markus HS, Droste DW, Kaps M, et al. Dual antiplatelet therapy with clopidogrel and aspirin in symptomatic carotid stenosis evaluated using doppler embolic signal detection: the clopidogrel and aspirin for reduction of emboli in symptomatic carotid stenosis (CARESS) trial. Circulation 2005;111:2233-2240.
Disclosure: The authors report no disclosures.
We thank Dr. Leung et al for their insightful comments and their interest in the NIH Wingspan intracranial stent registry study article. [1] The authors raise several important issues.
The group provided their local experience with re-stenosis after intracranial stenting with a self-expanding stent and report a re-stenosis rate of (5/19, 26.3%) which is similar to the rate we found. [1] Although most cases of re-stenosis were asymptomatic in our registry, we recognize the short follow-up of most patients in this registry (mean follow-up was only 5.8 months) does not exclude the possibility that some of these stenoses could become symptomatic over a longer follow-up period.
We agree that longer follow-up of a larger cohort of patients who undergo intracranial stenting is necessary to clarify this issue. This will be achieved in the randomized trial comparing stenting with medical therapy in patients with intracranial stenosis that our group will be initiating in the US in 2008. In the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial, 764 patients (382 patients in each arm) will be followed for a mean period of approximately 2 years.
We also agree that it is important to confirm intracranial stenosis by catheter angiography and the use of dual anti-platetelet therapy in clinical trials evaluating the safety and efficacy of stenting.
In SAMMPRIS, conventional digital subtraction angiography evidence of 70-99% intracranial arterial stenosis will be required for eligibility for the trial and aspirin and clopidogrel will be used for 90 days after enrollment in both treatment arms followed by aspirin monotherapy.
Disclosure: Dr. Zaidat consults for Boston Scientific Inc., the manufacturers of the Wingspan stent. Dr. Chimowitz reports no disclosures.