The Safety and Efficacy of Recombinant Tissue Plasminogen Activator (r-tPA) in Ischemic Stroke Patients in a Community-based Hospital

ABSTRACT

BACKGROUND: The results of the National Institute of Neurological Disorders and Stroke (NINDS) r-tPA Stroke Trial generated considerable hope, but also concerns about whether their results could be replicated in clinical practice. We investigated whether r-tPA infusion could be administered in a community-based hospital, safely and effectively. METHODS: We analyzed, retrospectively, the data of 33 patients having suffered acute ischemic strokes and treated with intravenous r-tPA from February 2003 to December 2006. Safety was evaluated by intracranial hemorrhage, symptomatic intracranial hemorrhage, and mortality. Clinical neurological status was measured by National Institutes of Health Stroke Scale (NIHSS) at baseline, 24 hours, and 7 days after r-tPA treatment. Efficacy was assessed by the response rate of r-tPA using an improvement in the NIHSS by 4 or more points at 24 hours after treatment and the long-term out-come measured with the modified Rankin Scale (mRS) at 3 months after stroke. RESULTS: The median NIHSS was 18. Mean onset to needle time was 140+/-30 minutes. Of the 33 patients, 10 had intracranial hemorrhage and 2 had symptomatic intracranial hemorrhage. No deaths occurred. Fifteen patients showed improvement in their NIHSS by 4 or more points at 24 hours after r-tPA. On the mRS, 12 patients had a good outcome at 3 months. More specifically, 9 patients had no or minimal symptoms, 7 patients had mild to moderate disability, 10 patients had severe disability and 7 patients died. CONCLUSION: The safety andrd efficacy of administering intravenous r-tPA for acute ischemic stroke in a community-based hospital mirror the results of the NINDS stroke trial.