Submaximal angioplasty for symptomatic intracranial atherosclerosis: A prospective Phase i study

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.