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A novel therapy for acute ischaemic stroke could challenge alteplase – the only approved treatment, research suggests.
The phase 2B trial of 75 patients published in the New England Journal of Medicine found that tenecteplase 0.25mg/kg was associated with significantly better reperfusion than alteplase when administered less than six hours after the clinical event.
Authors led by Dr Mark Parsons (John Hunter Hospitals, Newcastle, Australia) randomly assigned 75 patients who had experienced an ischaemic stroke within the past six hours to receive 0.9mg/kg alteplase or 0.1mg/kg or 0.235mg/kg tenecteplase – a genetically engineered mutant tissue plasminogen activator.
Patients selected for the study, on the grounds that they were more likely to benefit from thrombolytic therapy, had a perfusion lesion at least a fifth larger than the infarct core on baseline computed tomography (CT) imaging and a blocked vessel, according to CT angiography.
Patients in each treatment group had a mean National Institutes of Health Stroke Scale Score of 14.4+/-2.6 and a mean time to treatment of 2.9+/-0.8 hours. Compared with patients given alteplase, those in the two tenecteplase groups combined had better reperfusion (P+0.004) and clinical improvement (P<0.001) one day (24 hours) after treatment.
The 0.25mg/kg tenecteplase dose was associated with the best results for all endpoints.
Freedom from serious disability at 90 days was markedly more common among patients given 0.25mg/kg tenecteplase than those who received alteplase, at 72% versus 40% (p=0.02).
“Tenecteplase was associated with significantly better reperfusion and clinical outcomes than alteplase in patients with stroke who were selected on the basis of CT perfusion imaging,” the authors conclude.
New England Journal of Medicine
