Abstract 57: Tenecteplase versus Alteplase for Acute Ischemic Stroke (TAAIS) trial: A Randomized Trial using Advanced CT Selection.
Background. Intravenous alteplase remains the only approved treatment for acute ischemic stroke. In pilot studies, intravenous tenecteplase shows promise as a potentially safer and more effective thrombolytic.
Methods. TAAIS was a prospective, randomized, blinded-endpoint phase IIB trial. Seventy-five patients were centrally randomized to receive alteplase or one of two doses of tenecteplase (0.1 mg/kg and 0.25 mg/kg) <6 h after onset of ischemic stroke. Advanced CT imaging selection criteria included a perfusion CT (CTP) lesion at least 20% greater than the infarct core, with an associated vessel occlusion on CT angiography (‘dual-target’). Co-primary endpoints were: (i) Extent of reperfusion from baseline CTP to 24 hour perfusion-MR, and (ii) clinical improvement in acute to 24 h National Institutes of Health Stroke Scale (NIHSS) score. Secondary efficacy endpoints included excellent functional outcome at 90 days (modified Rankin Scale 0-1). Safety endpoints included large parenchymal hematoma (PH2).
Results Twenty-five patients each were randomized to the 3 treatment groups. Mean baseline NIHSS for all patients was 14.4 (SD 2.6), and time to treatment was 2.9 h (SD 0.8). The pooled tenecteplase group showed both greater reperfusion and clinical improvement at 24 hours than the alteplase group (p<0.001). Despite superior efficacy, there was a trend (p=0.09) towards less PH2 in the pooled tenecteplase patients (2/50, 4%) than in the alteplase group (4/25, 16%). The higher dose of tenecteplase (0.25 mg/kg) was superior for all efficacy outcomes compared to alteplase, or tenecteplase 0.1 mg/kg. This included a high rate of 3-month excellent functional outcome (72%, vs 40% for alteplase, p=0.023).
Conclusions Advanced CT selection identified stroke patients with improved clinical outcomes from tenecteplase compared to alteplase. This related to superior reperfusion seen with tenecteplase, particularly at the 0.25 mg dose.
- © 2012 by American Heart Association, Inc.