Abstract
Intravenous thrombolysis with recombinant tissue plasminogen activator (rtPA) improves the outcome for ischemic stroke patients who can be treated within 3 hours of symptom onset. The efficacy of thrombolysis has been demonstrated despite an increased risk of severe hemorrhagic transformation (HT) in patients treated with rtPA. We performed an analysis of risk factors for severe HT in the second European-Australasian Acute Stroke Study (ECASS II). HTs were classified by using clinical and radiological criteria as follows: hemorrhagic infarction (HI), parenchymal hemorrhage (PH), and symptomatic intracranial hemorrhage (SICH). Potential risk factors for HT were tested by stepwise logistic regression analysis, including rtPA-by-variable interactions. In addition, the distribution of bad outcome (modified Rankin score 5 to 6) at day 90 was stratified according to each category of HT. PH and SICH but not HI were associated with rtPA. Also, PH and SICH but not HI were more severe in rtPA-treated patients than in those receiving placebo. Risk factors for PH were rtPA, extent of parenchymal hypoattenuation on baseline CT, congestive heart failure, increasing age, and baseline systolic blood pressure. The risk of PH on rtPA was increased in older patients and in those who were treated with aspirin before thrombolysis. Risk factors for SICH were rtPA, congestive heart failure, extent of parenchymal hypoattenuation, and increasing age. The risk of SICH on rtPA was increased in patients who were treated with aspirin before thrombolysis. This secondary analysis of ECASS II has confirmed the importance of the extent of hypoattenuation as a risk factor for severe HT. The findings also suggest that older patients and those who have used aspirin before stroke are at higher risk of a severe HT on rtPA.
Highlights
Background and PurposeIntravenous thrombolysis with recombinant tissue plasminogen activator improves the outcome for ischemic stroke patients who can be treated within 3 hours of symptom onset
The findings suggest that older patients and those who have used aspirin before stroke are at higher risk of a severe hemorrhagic transformation (HT) on recombinant tissue plasminogen activator (rtPA). (Stroke. 2001;32:438-441.)
The efficacy of thrombolysis has been demonstrated despite an increased risk of severe hemorrhagic transformation (HT) in patients treated with rtPA.[1]
Summary
HTs were classified by using clinical and radiological criteria as follows: hemorrhagic infarction (HI), parenchymal hemorrhage (PH), and symptomatic intracranial hemorrhage (SICH). Potential risk factors for HT were tested by stepwise logistic regression analysis, including rtPA-by-variable interactions. The methods and primary results of ECASS II have been reported in detail elsewhere.[5] Briefly, ECASS II was a nonangiographic, randomized, placebo-controlled, double-blind trial of intravenous rtPA (0.9 mg/kg body wt, maximum dose 90 mg) in acute ischemic stroke. Eligible patients were men or women aged 18 to 80 years who had a clinical diagnosis of moderate to severe ischemic hemispheric stroke and who could be treated within 6 hours of symptom onset. The present analysis was performed on 793 patients because 7 patients were randomized but not treated
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