Background: Although tissue plasminogen activator (tPA) has been approved for use in acute ischemic stroke, concerns linger regarding its safety. We analyzed whether patients in special subgroups (i.e., age >70 years, baseline National Institute of Health Stroke Scale (NIHSS) score >20, diabetes, congestive heart failure (CHF), and of Hispanic origin) have a higher risk of symptomatic intracerebral hemorrhage (SICH) than patients without these characteristics.
Methods: Four prospective observational studies of acute ischemic stroke patients treated within 3 h with Alteplase were identified and individual patient data were pooled for this analysis. These included the Standard Treatment with Alteplase to Reverse Stroke Study [STARS, N = 389], Epidemiology Study of Ischemic Stroke [ESIS, N = 236], University Of Texas Houston Stroke Study [UT, N = 241], and Canadian Activase For Stroke Effectiveness Study [CASES, N = 1100]. The risk of SICH was calculated for all patients and for each of five subgroups.
Results: A total of 1966 patients were studied. Overall the risk of symptomatic ICH was 4.7% (95%CI, 3.8-5.8%) and the risk was similar among patients with and without each of the five characteristics. Patients with advanced age, baseline NIHSS score >20, CHF or diabetes had increased mortality and significantly lower rate of functional recovery.
Conclusions: The present study suggests that these specified subgroups of patients are not at increased risk of SICH after stroke thrombolysis compared to those without these characteristics.