109 Submaximal Angioplasty Prospective Registry: Preliminary Report

INTRODUCTION:Intracranial atherosclerotic disease (ICAD) accounts for approximately 10% of ischemic strokes. A recent study displayed high perioperative complications (15%) for treatment of ICAD with stenting. Recurrent stroke was found in 12% of patients treated with aggressive medical management, suggesting intervention may remain a viable option if perioperative risk is minimized. Angioplasty without stenting represents an alternative and understudied revascularization treatment for ICAD. A submaximal angioplasty limits the risk of thromboembolism, vessel perforation, and reperfusion hemorrhage frequently reported with stenting in the SAMMPRIS trial. Preliminary results of an ongoing registry are reported. METHODS:A phase 1 prospective registry for treatment of symptomatic ICAD with submaximal angioplasty was designed and 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. Neurological status measured by NIHSS and modified Rankin score were collected on days 0, 4, 30, 90, and at 1 year. The primary outcome measure is incidence of perioperative complications (combined endpoint includes death, stroke, and hemorrhage). Secondary outcome measure is stroke free survival at 90 days and 1 year. RESULTS:To date, 16 patients have been enrolled in this registry (81% men; mean age 63 years), with no intraoperative or perioperative complications. In follow-up (median 155 days) 15 patients remain stroke-free, with a single mild delayed stroke the only event in follow-up. CONCLUSION:We report interim analysis of a phase 1 prospective registry to assess the safety of submaximal angioplasty for ICAD. No perioperative complications have occurred to date in 16 patients. Long-term follow-up data at this point are limited to a single mild stroke in 2,588 person-days of follow-up. Updated material will be presented for the October conference.