The use of perfusion imaging to guide selection of ischaemic stroke patients for thrombolytic therapy remains controversial. Using two large independent cohorts, Bivard et al. demonstrate that perfusion imaging is able to identify patients who will benefit from treatment and that these patients are not readily identifiable using clinical assessments.

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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.

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