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Acute ischemic stroke

Imaging-guided tenecteplase treatment in an extended time window

From the Departments of Neurology, Radiology, and Centre for Clinical Epidemiology and Biostatistics, John Hunter Hospital/Hunter Medical Research Institute, University of Newcastle, Australia.

Address correspondence and reprint requests to Dr. Mark W. Parsons, Department of Neurology, John Hunter Hospital, Locked Bag No. 1, Hunter Region Mail Centre, New South Wales, Australia 2310 mark.parsons{at}hnehealth.nsw.gov.au

Background: Tenecteplase is a modified tissue plasminogen activator with a longer half-life and higher fibrin specificity than alteplase.

Methods: We conducted a prospective, nonrandomized, pilot study of 0.1 mg/kg IV tenecteplase given 3 to 6 hours after ischemic stroke onset. For a control group, we used patients contemporaneously treated with sub–3-hour 0.9 mg/kg IV alteplase following standard selection criteria. All patients underwent pretreatment and 24-hour perfusion/angiographic imaging with CT or MRI. Eligibility criteria for tenecteplase (but not alteplase) treatment included a perfusion lesion at least 20% greater than the infarct core, with an associated vessel occlusion. Primary outcomes, assessed blind to treatment group, were reperfusion (reduction in baseline–24-hour mean transit time lesion) and major vessel recanalization.

Results: Fifteen patients received tenecteplase, and 35 patients received alteplase. The tenecteplase group had greater reperfusion (mean 74% vs 44% in the alteplase group, p = 0.01) and major vessel recanalization (10/15 tenecteplase vs 7/29 alteplase, p = 0.01). Despite later time to treatment, more tenecteplase patients (10/15 vs 7/35 alteplase, p = 0.001) had major neurologic improvement at 24 hours (NIH Stroke Scale reduction 8). Four of the alteplase patients and none of the tenecteplase patients had parenchymal hematoma at 24 hours.

Conclusions: Tenecteplase 0.1 mg/kg, using advanced imaging guidance in an extended time window, may have significant biologic efficacy in acute ischemic stroke. The imaging selection differences between the tenecteplase and alteplase groups prevent a conclusive efficacy comparison. Nonetheless, these results lend support for randomized trials comparing tenecteplase with alteplase, preferably incorporating penumbral/angiographic imaging selection.

CBV = cerebral blood volume; CTA = CT angiography; CTP = perfusion CT; DWI = diffusion-weighted echo-planar spin-echo sequence; ICH = intracranial hemorrhage; MNI = major neurologic improvement; MR = magnetic resonance; mRS = modified Rankin Scale; MTT = mean transit time; NCCT = noncontrast CT; NIHSS = NIH Stroke Scale; PH = parenchymal hematoma; TIMI = Thrombolysis in Myocardial Infarction.

Supplemental data at www.neurology.org

Disclosure: M.W.P. and C.R.L. have received honoraria to speak at educational symposia sponsored by Boehringer-Ingelheim (who market alteplase and tenecteplase in Australia). All remaining authors have no disclosures.

Received April 16, 2008. Accepted in final form December 12, 2008.

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