Objectives: To examine a very large dataset to provide a robust answer to the question of whether visible infarction on computed tomography was (a) an independent predictor of functional outcome at all times up to 48 hours after stroke, and (b) independently associated with haemorrhagic transformation, with or without antithrombotic treatment.
Methods: The study assessed associations between visible infarction, time to randomisation, baseline neurological deficit, stroke syndrome, allocated aspirin or heparin treatment, recurrent haemorrhagic stroke, early death and six month functional outcome in the International Stroke Trial.
Results: Of 12 550 patients, 6267 (50%) had visible infarction up to 48 hours after stroke. The prevalence of visible infarction increased with increasing time from onset and extent of the stroke syndrome. Visible infarction was independently associated with increased death within 14 days (odds ratio (OR) 1.17, 95% CI 1.02 to 1.35), and of death or dependency at six months (OR 1.42, 95% CI 1.31 to 1.55), an absolute increase of 13%, or 130 per 1000 more dead or dependent patients with visible infarction than without it. There was no significant independent relation between visible infarction and fatal or non-fatal haemorrhagic transformation, or interaction between visible infarction and aspirin or heparin treatment allocation with six month functional outcome.
Conclusions: Visible infarction on computed tomography up to 48 hours after stroke is an independent adverse prognostic sign.