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Intracranial Angioplasty & Stenting Position Statement Intracranial Angioplasty & Stenting for Cerebral Atherosclerosis: A Position Statement of the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, and the American Society of Neuroradiology Stroke is the third leading cause of death and the 20) with the definitive National Institutes of Health leading cause of adult disability in North America, (NIH) study demonstrating a first year ischemic Europe, and Asia (1, 2). Intracranial cerebral athero- stroke rate in the pertinent vascular territory of at sclerosis accounts for approximately 8–10% of all least 11% (17). ischemic strokes with a higher reported incidence in the Asian, African, and Hispanic descent populations (3–5). Risk factors include insulin-dependent diabe- Review of Studies tes mellitus, hypercholesterolemia, hypertension, and Surgical Revascularization—EC/IC Bypass Trial cigarette smoking (6–8). In the United States, it is (Extracranial to Intracranial): In 1985, the EC/IC By- estimated that 40,000–60,000 new strokes per year pass Study Group published the results of a trial that are due to intracranial cerebral atherosclerosis. attempted to prove benefit for a surgical approach to treating intracranial atherosclerotic stenoses or occlu- Intracranial Atherosclerosis sion (18). This extracranial to intracranial arterial bypass trial was a prospective, multicenter, interna- Etiology tional study involving 1377 patients and attempted to Four mechanisms for ischemic stroke secondary to show that patients with an intracranial atherosclerotic intracranial atherosclerosis have been proposed: (1) stenosis or occlusion could benefit by an EC/IC by- hypoperfusion; (2) thrombosis at the site of stenosis pass. This trial failed for all subgroups, and in partic- due to plaque rupture, intraplaque hemorrhage, or ular for those with middle cerebral artery stenosis. occlusive plaque growth; (3) thromboembolic events There is therefore currently no approved surgical distal to the site of stenosis; or (4) direct occlusion of option for the patient population with intracranial small penetrating arteries at the site of the plaque arterial stenosis. The EC/IC bypass trial likely failed (9–14). due to lack of identification of the sub-segment of patients with a hypoperfusion mechanism as the pri- mary and underlying cause for their stroke. Stroke Risk Overview Review of Medical Therapy: The EC/IC Bypass The annual stroke risk from all causes in patients Study also provided data on the risk of stroke in with intracranial atherosclerosis is estimated to be patients with symptomatic carotid siphon or middle from at least 3.6% to more than 13% annually (14– cerebral artery stenosis or occlusion (18). Patients treated with medical therapy including management Members of the Writing Group: Randall T. Higashida (Chair), of stroke risk factors and aspirin (1300 mg per day) Departments of Radiology, Neurology, Neurological Surgery, and were evaluated as the control arm of this study. A Anesthesiology, Neurointerventional Radiology Division, Univer- defined subset analysis of the EC/IC Trial data found sity of California, San Francisco Medical Center, San Francisco, middle cerebral artery stenoses to have an annual CA; Philip M. Meyers, Departments of Radiology and Neurologi- ipsilateral ischemic stroke rate of 7.8% (14). cal Surgery, Neuroendovascular Service, Columbia University Medical Center, New York, NY; John J. Connors III, Interven- Thijs and Albers reported on 52 patients with doc- tional Neuroradiology Division, Baptist Hospital of Miami, Miami, umented symptomatic intracranial stenosis (16). Of FL; David Sacks, Department of Radiology, Reading Hospital and these 52 patients, 29 (56%) had a second documented Medical Center, West Reading, PA; Charles M. Strother, Depart- event (transient ischemic attack ͓TIA͔ or stroke) ment of Radiology, Division of Interventional Neuroradiology, Methodist Hospital, Houston, TX; John D. Barr, Interventional while on anti-thrombotic therapy (warfarin, heparin, Neuroradiology, Baptist Memorial Hospitals, Memphis, TN; Joan or antiplatelet agent). Of these 29 patients that failed C. Wojak, Interventional Neuroradiology, Our Lady of Lourdes medical treatment, 15 (52%) had another treatment Regional Medical Center, Lafayette, LA; and Gary R. Duckwiler, failure within a median of 36 days, and 8 of these 15 Department of Radiology, Division of Endovascular Neuroradiol- therapeutic failures were major stroke or death. In ogy, University of California–Los Angeles, Los Angeles, CA. This article will also appear in the October issue of the Journal of summary, out of 52 patients, 8 (15%) had a major Vascular and Interventional Radiology. stroke or were dead within a median time of 36 days. Address correspondence to Randall T. Higashida, MD, Neu- The WASID Studies (Warfarin vs. Aspirin for Symp- rointerventional Radiology Division, University of California, San tomatic Intracranial Disease): There have been 2 stud- Francisco Medical Center, 505 Parnassus Avenue, Room L-352, San Francisco, CA 94143-0628. ies of medical therapy that evaluated the efficacy and safety of warfarin and aspirin for intracranial athero- © American Society of Neuroradiology sclerotic stenosis and thus documented the natural 2323 2324 POSITION STATEMENT AJNR: 26, October 2005 history and attempted to determine “best medical investigators concluded that aspirin should be used in therapy”. The first was a retrospective study of con- preference to warfarin for patients with intracranial secutive patients with symptomatic intracranial steno- arterial stenosis. However, neither therapy offered sis evaluated by angiography between 1985 and 1991 acceptable protection from stroke. at participating institutions (15). Patients with symp- tomatic intracranial large artery stenosis Ͼ50% treated either with aspirin or warfarin (at the treating Intracranial Angioplasty and Stenting physician’s discretion) were evaluated for success of medical therapy (15). During a mean follow-up of Over the past 2 decades, a number of individual 14.7 months in the warfarin-treated group, there was reports, and 2 prospective multicenter trials, have an 8.4% stroke or death rate, and in the aspirin been published regarding intracranial angioplasty and treated group (mean follow-up 19.3 months) there stenting. Patients with symptomatic or asymptomatic, was an 18.1% rate of major stroke or death, with 9% severe intracranial atherosclerotic stenosis who were stroke in the same vascular territory. In a subset with at high risk for stroke or death were included posterior circulation stenosis, with follow-up of 100 (22–41). patient years and a mean follow-up of 13.8 months, the annualized stroke rate in the territory of a stenotic basilar artery was 10.7% and in the territory of the Literature Review vertebral artery it was 7.8%. The earliest reports of balloon angioplasty for in- Based upon these data, a second pivotal trial was tracranial atherosclerosis were reported in the mid subsequently performed. The multi-center, random- 1980’s. However, by the late 1990’s, the development ized, double-blind NIH-sponsored Warfarin-Aspirin of improved micro-balloon catheters and smaller bal- Symptomatic Intracranial Disease Trial ͓WASID͔) loon expandable stents, initially for coronary applica- was performed from 1998–2003. It was hypothesized tions, lead to an increasing number of reports on that the optimal anti-thrombotic therapy for symp- revascularization of cerebral blood vessels for intra- tomatic intracranial arterial stenosis was uncertain cranial atherosclerosis. In a number of individual se- (17). Patients with transient ischemic attack or minor ries of cases reported, the technical success rates have stroke caused by an angiographically verified stenosis exceeded Ͼ90%, with clinical complication rates of Ͼ50%, of a major intracranial artery and with no ranging from 0–20% (22–38). other apparent etiology, were randomized to receive Gress et al published the results of intracranial either warfarin (INR 2–3) or aspirin (1300 mg/day). angioplasty in 25 patients for symptomatic vertebro- The primary endpoint was prevention of stroke and basilar ischemia in whom medical therapy had failed vascular death. The WASID trial was prematurely (30). Angioplasty was effective in reducing the degree halted by the NIH on the recommendation of the of stenosis by Ͼ40% in all 25 vessels. These authors external Performance and Safety Monitoring Com- concluded that intracranial angioplasty is effective in mittee “after 569 patients had undergone randomiza- the reduction of stenosis and can be performed with tion because of concerns about the safety of the pa- relative safety. tients who had been assigned to receive warfarin” In 1999, Marks et al reported upon 23 patients who (17). underwent successful angioplasty for atherosclerotic These 569 patients (out of a projected 806) were intracranial stenosis, describing both the immediate followed for a mean of 1.8 years. In the aspirin and long-term outcomes (40). They reported a 91.3% treated patients, ischemic stroke in the same vascular success rate in decreasing the stenosis and one territory occurred in one year at the rate of 12%, and periprocedural death. Follow-up ranged from 16 to 74 in warfarin treated patients at the rate of 11%. Death months (mean 35.4 months) and there was an annual occurred in 4.3% of patients in the aspirin group, rate of 3.2% for strokes in the territory appropriate to versus 9.7% death in the
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