title: Submaximal angioplasty for symptomatic intracranial atherosclerosis: a prospective Phase I study.
abstract: OBJECTIVE Intracranial atherosclerotic disease (ICAD) accounts for approximately 10% of ischemic strokes. The recent Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study demonstrated a high incidence of perioperative complications (15%) for treatment of ICAD with stenting. Although the incidence of stroke was lower in the medical arm, recurrent stroke was found in 12% of patients despite aggressive medical management, suggesting that intervention may remain a viable option for ICAD if perioperative risk is minimized. Angioplasty without stenting represents an alternative and understudied revascularization treatment for ICAD. Submaximal angioplasty limits the risks of thromboembolism, vessel perforation, and reperfusion hemorrhage that were frequently reported with stenting in the SAMMPRIS trial. The authors conducted a prospective Phase I trial designed to assess the safety of submaximal angioplasty in patients with symptomatic ICAD. METHODS This study was approved by the local institutional review board. Demographic and clinical data were prospectively collected. Angioplasty was performed with a balloon undersized to approximately 50%-70% of the nondiseased vessel diameter in patients with symptomatic ICAD who had angiographically significant stenosis of ≥ 70%. The primary outcome measure was the incidence of periprocedural complications (combined rate of death, stroke, and hemorrhage occurring within 30 days and at 1 year). RESULTS Among the 65 patients with symptomatic ICAD who were screened, 24 had significant angiographic stenosis that met the inclusion criteria of this study. The mean age was 64.08 years (median 65 years; SD ± 11.24 years), most were men (62.5%), and most were white (66.67%). Many patients had concomitants of vascular disease, including hypertension (95.8%), hyperlipidemia (70.83%), smoking history (54.1%), and diabetes mellitus (50.0%). Coronary artery disease (41.66%) and previous stroke or transient ischemic attack (45.83%) were frequently present. Most patients (75%) had anterior circulation stenosis. The mean preprocedure stenosis was 80.16% (median 80%, range 70%-95%). Submaximal angioplasty was performed in patients who met the inclusion criteria, with a mean postangioplasty stenosis rate of 54.62% (median 55.5%, range 31%-78%). Rates of ischemic stroke in the territory of the treated artery were 0% within 30 days and 5.55% (in the only patient who presented with recurrent stroke) at 1 year. The mortality and hemorrhage rates in this series were 0%. CONCLUSIONS This study demonstrates the safety of the submaximal angioplasty technique, with no permanent periprocedural complications in 24 treated patients.
authors.affiliation: Department of Neurosurgery, Division of Surgery, and Department of Medical Imaging, University of Arizona, Tucson, Arizona;|Departments of 2 Neurosurgery.|Department of Neurosurgery, Gates Vascular Institute/Kaleida Health, Buffalo.
authors.forename: Travis M
authors.initials: TM
authors.lastname: Dumont
authors.affiliation: Departments of 2 Neurosurgery.|Department of Neurosurgery, Gates Vascular Institute/Kaleida Health, Buffalo.
authors.forename: Ashish
authors.initials: A
authors.lastname: Sonig
authors.affiliation: Departments of 2 Neurosurgery.|Department of Neurosurgery, Gates Vascular Institute/Kaleida Health, Buffalo.|Departments of Neurology and Neurosurgery, University of South Florida College of Medicine, Tampa, Florida; and.
authors.forename: Maxim
authors.initials: M
authors.lastname: Mokin
authors.affiliation: Departments of 2 Neurosurgery.|Department of Neurosurgery, Gates Vascular Institute/Kaleida Health, Buffalo.|Cerebrovascular Neurosurgery, Oregon Heart and Vascular Institute, Springfield, Oregon.
authors.forename: Jorge L
authors.initials: JL
authors.lastname: Eller
authors.affiliation: Departments of 2 Neurosurgery.|Department of Neurosurgery, Gates Vascular Institute/Kaleida Health, Buffalo.
authors.forename: Grant C
authors.initials: GC
authors.lastname: Sorkin
authors.affiliation: Departments of 2 Neurosurgery.|Radiology, and.|Neurology, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York.|Department of Neurosurgery, Gates Vascular Institute/Kaleida Health, Buffalo.
authors.forename: Kenneth V
authors.initials: KV
authors.lastname: Snyder
authors.affiliation: Departments of 2 Neurosurgery.|Radiology, and.|Department of Neurosurgery, Gates Vascular Institute/Kaleida Health, Buffalo.|Toshiba Stroke & Vascular Research Center, University at Buffalo, State University of New York; and.|Jacobs Institute, Buffalo, New York.
authors.forename: L Nelson
authors.initials: LN
authors.lastname: Hopkins
authors.affiliation: Departments of 2 Neurosurgery.|Radiology, and.|Department of Neurosurgery, Gates Vascular Institute/Kaleida Health, Buffalo.|Toshiba Stroke & Vascular Research Center, University at Buffalo, State University of New York; and.
authors.forename: Elad I
authors.initials: EI
authors.lastname: Levy
authors.affiliation: Departments of 2 Neurosurgery.|Radiology, and.|Department of Neurosurgery, Gates Vascular Institute/Kaleida Health, Buffalo.|Toshiba Stroke & Vascular Research Center, University at Buffalo, State University of New York; and.|Jacobs Institute, Buffalo, New York.
authors.forename: Adnan H
authors.initials: AH
authors.lastname: Siddiqui
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000379:methods*; D005260:Female; D006801:Humans; D002537:Intracranial Arteriosclerosis / Q000175:diagnosis / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
keywords: BI = Barthel Index; COSS = Carotid Occlusion Surgery Study; ICAD = intracranial atherosclerotic disease; MCA = middle cerebral artery; NIHSS = National Institutes of Health Stroke Scale; SAMMPRIS = Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis; TIA = transient ischemic attack; angioplasty; endovascular; intracranial atherosclerosis; mRS = modified Rankin Scale; stroke; vascular disorders