Abstract 3980: Early Results of Stenting for Acute Stroke Intervention Following Full Dose IV Alteplase (SASI-1 Study)
Background and Purpose: Strategies for rapid restoration of flow using fibrinolytic therapy followed by acute stenting have been well studied for myocardial infarction. Previously reported data, on older stent designs, suggested that there may be an unacceptably high risk of Intracerebral Hemorrhage (ICH). Also reported were high rates of technical failure when using this strategy for ischemic stroke treatment. The SAS-1 study was designed to address this safety concern and look into the technical feasibility of the procedure.
Methods: Patients were enrolled prospectively at a university-affiliated community hospital for this phase I trial from November 2009 to June 2011. Standard angiographic techniques, self expanding stents (SES) and anti-GIIb-IIIa were used following lack of improvement after administration of IV Alteplase. Angiographic recannalization (R) was recorded using modified TIMI and Qureshi grading scales. CT scans were performed immediate post procedure and at 24 hours. Clinical evaluations were performed at presentation, 24 hours, 7 to 10 days and/or at discharge, and 3 months after the treatment. All adverse events were noted. Safety stopping rules were prespecified. Results were analyzed using SPSS (11.0) software.
Results: Of the 1012 ischemic stroke patients 64 were screened for the study. Nineteen patients met the study criteria (Mean Age 68.9, Range 38-93, Males = 7(36.84%), Females - 12(63.16%)). For this early analysis primary outcomes of interest were: (1) Technical feasibility (2) Recannalization Rates (Complete and Partial); and (3) serious adverse events within 72 hours (4) neurologic outcome within the first week. Fifteen patients had intracranial stenting (MCA n=12, basilar n=1, IC n=1) and 5 had extracranial carotid stents. There were no technical failures. In 2 patients stents were retrieved following complete recannalization. Comparison with historical studies suggests high recannalization rates (Complete Recannalization - 47.37%, Partial Recannalization - 47.37%), low occurrence of symptomatic ICH (n=1, 5%) and asymptomatic ICH (n=3, 15%). No other serious adverse events were noted. Early Neurological Improvement was seen in 63.16% (n=19). Three month follow-up are still not complete for all patients.
Conclusion: The observed proportions of neurologic deterioration and serious adverse events were below the prespecified safety thresholds. There were no technical failures. The results form the basis of a larger randomized trial addressing the efficacy of full dose intravenous alteplase followed by acute stenting.
- © 2012 by American Heart Association, Inc.