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Enhanced Recovery From Ischemic Occlusion With Combined Lytic Therapy and Ultrasound Monitoring: Presented at ESC

By Michael J. Worthington

MANNHEIM-HEIDELBERG, GERMANY -- May 18, 2004 -- Ischemic stroke patients treated with lytic therapy have earlier recovery rates if they are monitored with transcranial ultrasound, said researchers here May 15^th at the 13^th European Stroke Conference.

The CLOTBUST Trial (Combined Lysis of Thrombosis in Brain Ischemia using 2 MHz Transcranial Ultrasound and Systemic tPA) was a phase 2 multicenter, randomized trial with the aim of determining the efficacy and safety of combining systemic treatment with tissue plasminogen activator (tPA) in patients undergoing ischemic stroke.

Principal investigator Dr. Andrei Alexandrov, Assistant Professor, Department of Neurology, University of Texas Medical Center, Houston, Texas, reported that pilot studies have shown transcranial Doppler (TCD) monitoring results in complete recanalization and "dramatic clinical recovery" in patients treated with lytic therapy. Therefore, they designed a Phase II trial with 126 patients to examine the treatment further.

Patients were enrolled, fitted with a TCD device and treated with tPA 0.9 mg/kg within 3 hours of symptom onset. All patients had a TCD-confirmed middle cerebral artery occlusion (Thrombolysis in Brain Ischemia obstructive residual flow grades 0-3) prior to receiving the tPA bolus. Patients in the control arm were fitted with the head-frame device but did not receive TCD monitoring.

TCD monitoring in the active group was done before tPA bolus delivery and up to 2 hours after bolus. Both groups received a TCD diagnosis at the end of that period. National Institutes of Health Stroke Scale (NIHSS) scores were taken throughout the monitoring period, at 24 hours after onset of symptoms, and at 3 months.

According to Dr. Alexandrov, 49% of the TCD monitored patients achieved the primary combined end point at 2 hours or more after bolus (i.e. combined complete recanalization or total NIHSS 3 or more, or recovery by 10 or more NIHSS points), compared to 30% of control patients (P </=.02). Complete recanalization was seen in 46% of the monitored patients compared with 17.5% of controls, and 27% of the monitored patients did not achieve recanalization compared with 49.5% of controls (P <.001 for both).

The difference in clinical end points between the groups were not statistically significant at 2 hours and 24 hours, however, there was a trend for better scores in the monitored group, Dr. Alexandrov said. He cautioned that the trial was not powered to detect differences in clinical outcomes.

In terms of safety, although intracranial hemorrhages were detected in both groups during therapy during TCD monitoring (4.8% in each), none were detected during TCD monitoring. This led the investigators to conclude that continuous monitoring of intracranial occlusion with 2 MHz TCD is safe and effective.


[Presentation title: CLOTBUST]

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