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      Abciximab Safe and Effective for Supratentorial Ischemic Stroke: Presented at ESC

      By Michael J. Worthington

      MANNHEIM-HEIDELBERG, GERMANY -- May 18, 2004 -- Abciximab, a treatment commonly used for acute coronary syndromes and percutaneous coronary interventions, is safe and effective for the short-term treatment of supratentorial ischemic stroke, according to researchers speaking here on May 14th at the 13th European Stroke Conference.

      Lead investigator, Panayiotis Mitsias, MD, Department of Neurology, Henry Ford Health System, Detroit, Michigan, explained that although abciximab is not approved for the treatment of acute stroke, an earlier study by the Abciximab in Ischemic Stroke Investigators showed the agent was safe and effective for stroke when administered within 24 hours of onset and the findings suggested there was improved functional outcome.

      To determine the safety and efficacy of abciximab on clinical recovery after supratentorial stroke, Dr. Mitsias and colleagues conducted a pilot study. They were also interested in assessing the effect of abciximab on the evolution of ischemic lesion size, as determined by magnetic resonance imaging (MRI).

      They enrolled 29 patients with supratentorial stroke and a National Institutes of Health Stroke Score (NIHSS) of 4 or greater. Patients were treated with intravenous abciximab 0.25 mg/kg bolus for 1 minute, followed by 0.125 mcg/kg/min (max 10 mcg/min) continuous infusion over 12 hours.

      Patients underwent MRI at baseline, 24 hours after treatment completion, and 1 to 3 months after onset of symptoms. Other evaluations included NIHSS evaluation at baseline, 48 hours and 1-3 months after symptom onset and Trial of ORG 10172 in Acute Stroke Treatment (TOAST) classification at the time of outcome assessment. Results were compared to 39 untreated historical controls. The investigators also performed an MRI analyses to assess lesion size change from baseline.

      According to Dr. Mitsias, the mean time interval from stroke onset to treatment was 14.8 hours. At 48 hours, patients treated with abciximab showed a median NIHSS improvement of 4 points, compared to 0 for controls (P =.0097). At that same time point, MRI images of patients with non-lacunar stroke revealed a 25% decrease in lesion size in treated patients, compared to a 39% increase in control patients (P = 0.0018). At 1 to 3 months, NIHSS had improved by 5 points, compared to 4 points for controls (P = NS). At that same time point, the baseline diffusion-weighted imaging (DWI) to outcome T2-weighted imaging (T2WI) lesion size increased by 18%, compared to 17% for controls.

      Although the study was small, results indicate that abciximab has a positive effect on MRI parameters of stroke, at least in the short-term, Dr. Mitsias said. Abciximab decreased the ischemic lesion size, however, this was not maintained over the 1 to 3 months of follow-up.

      "It seems there is an initial influence on the evolution of these lesions but this doesn't hold until the end -- this is a mystery we have to uncover," Dr. Mitsias said. "Maybe we need to combine abciximab with something else; this alone does not seem to be sufficient," he said.

      "Certainly, early improvement is good. People can go home quicker, but the final outcome is not as good as we expected," he added. "The good part is that [treatment] is very safe; we didn't see the bleeds you would see with [tissue plasminogen activator]."

      Dr. Mitsias and colleagues are now conducting a randomized study of about 100 patients to explore further the effects of abciximab treatment in stroke patients.


      Presentation title: "Clinical and MRI Response to Abciximab Treatment of Supratentorial Stroke"



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