Abstract W MP6: SAVER I: Superselective Administration of VErapamil during Recanalization in Acute Ischemic Stroke. A Phase I Feasibility Study
Large vessel occlusive ischemic stroke results in high rates of morbidity and mortality. While intravenous t-PA and intra-arterial (IA) thrombectomy are mainstays in acute stroke therapy, clinical outcomes lag significantly behind improving rates of acute revascularization. Thus, there is a critical need for a novel adjunctive therapy to reduce stroke burden and to improve outcome. Previous neuroprotective drug studies failed due to long intervals between symptom onset and drug administration, lack of concordant thrombolytic revascularization, and lack of targeted administration to the affected vessel. Through a retro-engineered mouse model of large vessel stroke allowing concomitant recanalization and selective intra-arterial (IA) administration we previously evaluated verapamil, a calcium channel blocker (CCB) that is already safely injected intra-arterially (IA) for vasospasm. In this clinically relevant model, verapamil was highly neuroprotective when combined with vessel recanalization. Based on this data, we conducted a single-institution Phase I study to evaluate the feasibility and safety of superselective IA verapamil (10mg) administration immediately following mechanical thrombectomy. We collected information about demographics, location of the occlusion, last known normal time, time to and recanalization. Evaluation of CTA collateralization was performed using a previously a published grading scale (Souza et al. AJNR. 2012). The primary endpoint was symptomatic intracranial hemorrhage (ICH) within 24 hours post-procedure as defined by the Interventional Management Stroke (IMS) III Trial (Broderick et al. NEJM. 2013). Patients were monitored and graded at 3 months with the modified Rankin Score (mRS). Of the enrolled patients, none had a significant ICH, and none died as a direct result of the procedure. Clinical outcome results for patients were encouraging, and warrant further study. These results will be used to support a Phase II dose selection study.
Author Disclosures: J.F. Fraser: Research Grant; Modest; Grant Support NIH UL1TR000117. M.E. Maniskas: Research Grant; Significant; NIH T32 Training Grant. A. Alhajeri: None. G.J. Bix: None.
- © 2015 by American Heart Association, Inc.